ML20027B968

Discusses Review of Hosp Rept Re Misadministration of I-125 Seed Implant Therapy.Rept Does Adequate Job of Defining Magnitude of Misadministration.Contributing Causes Unclear. Related Info Encl

ML20027B968
Person / Time
Issue date:	03/09/1981
From:	Miller V NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Nussbaumer D NRC OFFICE OF STATE PROGRAMS (OSP)
Shared Package
ML20027A639	List: ML20027A638 ML20027B955 ML20027B956 ML20027B957 ML20027B958 ML20027B960 ML20027B962 ML20027B968 ML20027B969 ML20027B971 ML20027B972 ML20027B973 ML20027B974
References
FOIA-82-335 NUDOCS 8210120055
Download: ML20027B968 (82)

Text

{{#Wiki_filter:- p Kac, o UNITED STATES 8 o 8 ).,., NUCLEAR REGULATORY COMMISSION W ASHINGTON, D. C. 20555 ~.* \\ /: E C .%7 9:: MEMORANDUM FOR: Donald A. Nussbaumer, Assistant Director for Agreement States Program Office of State Programs FROM: Vandy L. Miller, Chief. Material Licensing Branch Division of Fuel Cycle and Material Safety, NMSS

SUBJECT:

REVIEW 0F HOSPITAL REPORT ON MISADMINISTRATION OF I-125 SEED IMPLANT THERAPY We have reviewed the subject report, as you requested, In general, the report does an adequate job of defining the magnitude of the misadministrations. The report does not make it clear, however, whether the physicians, although board certified, did not have sufficient training or whether there were other contributing causes for what they did. Based on the report, we will ask the appropriate members of the Advisory Committee on the Medical Uses of Isotopes if certification in radiology by the American Board of Radiology is sufficient evidence of training and experience to use any of the sealed sources for therapy listed in 10 CFR 35.100, Schedule A, Group VI. t {y r 0-gyindy L. Mil ller, Chief Material Licensing Branch Division of Fuel Cycle and Material Safety, NMSS l-AE l 8210120055 820020 PDR FOIA DAVIESS2-335 PDR

s a 1 ..s -( 0 "+T 4 y O1 .oo oa University of Colorado Health Sciences Center gpa^ University Hospitais

200 East N'ntn Avenue.

[A>~M School of Mecicine Denver. Co:crade 80262

• ' E '1 A Schoo; of Nursing

/ Sct col of Centistry v March'10, 1981 Mr. Alphonso A. Topp, Jr. Program Manager Licensing and Registration Section State of New Mexico Environmental Improvement Division Post Office Box 968 Santa Fe, New Mexico 87503

Dear Mr. Topp:

This is a report of my review of materials received on February 27 describing apparent misadministrations associated with iodine 125 seed implant therapy over the period December, 1977 to July, 1979 at St. Joseph Hospital in Albuquerque, New Mexico. Materials reviewed were: 1. Letter dated February 23, 1981 from G. Wayne Kerr to me requesting my participation in the review 2. Guidelines for consultants 3. Instructions for consultants and advisors for obtaining reimbursements 4. Summary of DOE-OHER program 5. Letter dated December 31, 1980 from Alphonso Topp to Sister Celestia Koebel 6. Letter dated February 2, 1981 from Sister Celestia Koebel, President of St. Joseph Hospital, to Mr. Alphonso Topp, Program Manager, Licensing and Registration Section, Environmental Improvement Division, State of New Mexico 7. Summary report dated January 27, 1981 from Charles Kelsey, Ph.D. 8. Letter dated February 3, 1981 from Theodore A. Wolff to Donald A. Nussbaumer requesting an independent cechnical review '9. Article dated February 3, 1981 frca The Albuquerque-Journal ontitled "St. Joseph's Says 13 ?ier2 Overirradiated". k Iht Uruversity Of CCloradQ os 8119 UJI 0000ftunt:V et?'ployer.

Mr. Alphonso A. Topp, Jr. March 10, 1981 - Page Number Two ,As part of my review, the following telephone conversations were held: 1. Alphonso Topp (2) March 6, 1981 2. Charles Kelsey, March 6, 1981 3. Lowell Anderson, Sloan Kettering Institute and Memorial Hospital, New York City, March 6, 1981 4. Dennis Leavitt (2) Medical Physicist, University of Utah, March 9, 1981. This report is structured in two parts: 1. Critique of the report dated January 27, 1981 from Charles Kelsey, Ph.D. 2. Critique of the letter dated February 2, 1981 from Sister Celestia Koebel to Alphonso Topp CRITIQUE OF THE REPORT DATED JANUARY 27, 1981 FROM CHARLES KELSEY, PH.D. Page 1: No comments. Page 2: With respect to the installation of the treatment planning system at St. Joseph Hospital, it may be helpful to separate this sytem into two components. The first component is the computer hardware which apparently was + purchased from a regional distributor of Tektronix Computer Systems in the summer of 1977 without the direct involvement of Dennis Leavitt, Ph.D. This hardware system was apparently the third Tektronix system purchased for radiation therapy treatment planning,with the two systems purchased earlier installed at institutions in Ogden, Utah and York, Pennsylvania. The second component is the treatment planning software which apparently was brought to the attention of representatives of St. Joseph Hospital following a talk in Albuquerque by Dr. Leavitt at a meeting on Computer Applications in Radiology. Following the talk, St. Joseph inquired about the availability of the software and then visited the University of Utah foi a demonstration. Subsequent actions appear to follow the-schedule below: Summer '77 visit.by Mr. Sachs to University of Utah Fall '77 Installation'of Tektronix hardware ~ Fall '77 Visit by Dr. Leavitt to St. Joseph

l;..: Sk. Alphonso A. Topp, Jr. -lf - March 10, 1981 ' Page Number Three L I December78 Visit by Dr. Leavitt to St. Joseph August '79-Visit by Dr. Leavitt to St. Joseph March '80 Visit by Mr. Sachs to University of Utah for I l computer software update October '80 Visit by associate of Dr. Leavitt to St. Joseph l i .The statement "The accuracy of the UNM CRTC and Universitv i of Utah program has been verified by independent dostmetry measurements" is unclear. According to Drs. Kelsey and Leavitt, the accuracy of the UNM' programs was verified by dosimetric f measurements made locally, whereas the accuracy of the t University of Utah programs was' verified by dosimetric l measurements made in other locations by individuals who used variants of the Utah software on their own treatment planning-computers. (Rad-8 and AECL). i Comments at the bottom of Page 2 concerning the prescription 'of tumor dose in I-125 prostate therapy are correct. It is also true that limiting doses to the bladder, rectum or other normal tissues are generally not prescribed. There.is no comment in the report concerning the volume of the prostate estimated before implantation or determined during the implantation procedure. At least the volume determined during the'implaht should be recorded in the patient's chart and. from this volume the number of seeds to be implanted can be determined according to well-formulated rules. In most of the patients described in Table II, the number of seeds greatly i i exceeds.tlut iumber anticipated for:the largest conceivable prostate volume. In addition, the number used greatly exceeds by far the number described for prostate treatment 1 in various articles in the literature. Page 3: In the statement "The Univergity of-Utah program used an iridium gamma factor of 1.7 rad-cm / mci hr.", the word " iridium" should.be replaced by " iodine-125". The value of i l.7 represents a preliminary value for the absorbed dose ratefconstant for I-125 which was generally' accepted in the i -early period of iodine implant therapy. However, a change'in i this;value was recommended in the summer of 1978 by the medical physics group at Memorial Hospital in New Yorg/=Ci-hr. At the present time, the recommended value is 1.1 rad-cm This value' represents the maximum dose rate 235t e curve of i dose rate versus distance in tissue-from an I seed.* In-l '*An inrermediail5value f 1.45 (or 1.47) also has,been reported for I..This value has units of R-cm / mci-h When/ corrected by an f-factor'of 0.9 and an average tran3 mission 1 factor of 0.86 ove; 4 3 geometry, the.value of:1.45 R-cm / mci-hr - t Jyields 1.1. rads-cm'/ mci-h.. i 1 g a-,-r r- -,., - ,w

Mr. Alphonso A. Topp, Jr. March 10, 1981~ Page: Number Four addition, the group at Memorial has determined that the dose rate fall off from the location of maximum dose rate is somewhat less rapid than thought earlier. Use of an absorbed dosg rate constant of 1.1 rad-cm / mci-hr in place of 1.7 rad-cm / mci-hr results in a considerable reduction in doses to tissues at some distance from an I-125 seed. This reduction in estimated dose is applicable to the doses in Table II. The reduction is not simply the ratio (1. 0 ) / (1. 7 ), as the dose fall off with distance in tissue is somewha less rapid than estimated originally for the value 1.7 rad-cm}/ mci-hr. Recomputation of these doses with up-to-date I-125 data'from Memorial Hospital is recommended. The remaining computations on Page 3 are correct and the analysis concerning the conversion from dose rate to total dose is also correct. Furthermore, the origin of the con-version coefficients of 445 and 2074 also appears to be correct, as does their applicability to source activities expressed in mci and mg-Ra-eq of I-125. Page 4: This reviewer agrees with the conclusion in Dr. Kelsey's report than an incorrect conversion of 445 was used to convert dose rate in rads /hr to total dose in rads. With this incorrect conversion, the total dose estimated for the I-125 seeds was too low by a factor of 4.7. Apparently these low estimated doses led to a compensatory technique of using an excess number of seeds and/or boost fields of external radiation. These compensatory techniques resulted in excessive absorbed doses of radiation to the prostate and surrounding normal tissues. The large number of seeds and the employment of intensive boost fields are so far beyond standard practice for.I-125 implant-therapy that it is s' difficult to imagine why these procedures were not questioned ~ by the radiation therapists, particularly since the standard practice for I-125 theracy is well described in the radiation oncology literature. The first recommendation at the bottom of Page 4 is probably the most important recommendation to be made to prevent a racurrence of these events. This recommendation should be extended as a general recommendation for any radiation oncology -operation in which implant, supervoltage or megavoltage therapy is practiced. Insistence upon this level of expertise should be included as a general condition of lincensure for radiation therapy employing sources of radioactivity governed by the Nuclear Regulatory Ccamission or state departments of health. s a w e '~

LMr. Alphonso A.-Topp, Jr. C March 10, 1981 j*- page Number'Five i page 5: This reviewer agrees with each of the recommendations on this page. [ Table II: Comments are offered above related to revision of the I-125 dosgs as a reflection of substitution o( the. value of 1.1 rad-cm / mci-hr for the value of 1.7 rad-cm~/ mci-hr i for.the absorbed dose rate constant for I-125. Additional comments on the total doses. listed in Table II are necessary because of the different dose rates administered by the I-125 seeds compared to the external fields. That is, the biologically f effective dose administered by the I-125 seeds would be different-from that delivered by the external fields even though the total doses may be equal. Consequently it is difficult to judge the relative biological effectiveness of total doses achieved by different combinations of I-125 seeds i and external fields. I CRITIQUE OF THE LETTER DATED FEBRUARY 2, 1981 FROM SISTER CELESTIA KOEBEL TO ALPHONSO TOPP Page 1: The efforts of St. Joseph Hospital to investigate the situation related to I-125 implant patients at the hospital appear to be both sincere and thorough. Each of the consultants is a highly respected professional in his or her field. Page 2: As described above, absorbed doses to all regions of anatomy will be somewhat different'if more up-to-date data concerning I-125 dosimetry are employed. This reviewer-recommends that the absorbed doses in Table II be recomputed using the more up-to-date data from Memorial Hospital in New York. Page 3: This reviewer also was unable to ascertain the reason why an incorrect multiplicative factor of 445 was used in converting dose rate to' total dose for I-125. -It probably is l true that the incorrect value represents a failure in communication ~ between medical physicists at the University of Utah and the representatives of St. Joseph's Hospital. How'this value remained in use for over 18 months without detection is even less clear. What happened between July, 1979 and December 1980 with regard to -125 therapy at St. Joseph Hospital is not described in any of.the material available to this reviewer. One possibility is that version III of the treatment planning program became available in July,-1979. Since this version provided total doses in rads as part of tho. computer output, a conversion factor for dose rate to total dose was no longer required. However, if this were the case, then the number of -seeds and the intensity of boost fields would have been dramatically reduced from'those employed previously.when the incorrect conversion factor was used. This dramatic' reduction e. v.-

Mri Alphonso A. Topp, Jr. Mnrch-10, 1981 Page' Number Six should have.been detected instantly by radiation oncology personnel at St. Joseph Hospital. With respect to item (3) of the measures proposed to avoid future problems, a few comments may be in order. The commercial availability of computerized treatment planning systems represents a distinct advancement in the thoroughness with which radiation treatments can be administered. However, these systems can lull radiation oncology personnel into a false sense of security and can result in serious errors if the use of the systems and their limitations are not thoroughly understood by the user. In all cases, the accuracy of the dosimetric data furnished by the computer should be verified for the particular treatment units and methodologies employed by the user. In addition, complete documentation of the applications and limitations of the j treatment planning systems should accompany the systems and should be emphasized to the purchaser during installation. This reviewer is unconvinced that this documentation and emphasis always occurs. Enclosed with-this report are copies of correspondence, scientific articles and manufacturer's literature cencerned with I-125 implant therapy and the dosimetry thereof. Also enclosed are a couple of documents related to levels of staffing appropriate for a radiation oncology operation. Any questions concerning this report should be brought to j the immediate attention of the author. Sincerely yours, s .d..L L_, v fA -N William R. Hendee, Ph.D. Professor and Chairman _ Department of Radiology School'of Medicine WRH:kjw enclosures cc:p/I Wayne Kerr r ~ t

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. Frost r!!F i swl R MtsFARt il sND 1R!MIstFN I i hN il R. I NIVI Rsil) Ut' Nt W sti sa e8 \\t ut 4 3 Rs.H I. New siEn o citi. rsA. COMPUTATION OF DOSE DISTRIBUTIONS FOR RADIOACTIVE SEED IMI't. ANTS 1.1. RosEN. R. G. l.ANE and C. A. KFI.NFY Interstitial and intraeavitary implants with is described. The program can hand!e up to.410 '"I radioactise seeds permit irradiation of localized or "':Ir seeds. Seed coordinates can be entered using tumors with higher doses to tumor and lower Joses either the keyboard or a sonie digitizer from either to surrounding normal tiwne than are powible with oithogonal or steieo tilms. I he pmgnun piodnees a external heams. Temporary implants are typically data file containing a dose matris. This output data used for earcinoma of the cervix. vagina, rectum, file can be combined with the output of other treat-ortd cavity, and oropharynx. Permanent implants ment planning programs to proside total treatment are typically used for malignancies in such sites as plans for combined modalities. Separate programs the prostate. lung, bladder. and ly mph nodes. Some display and plot the isodose distributions. The last review anieles on implantation technique. d nime-ease run is saved in a temporary life; therefore. until try. and clinical results include ANCERSON t 1975). a new case is entered. the last case can be recalled SYF.D & FEDER 419771. Hit.ARis i1968. 19761. easily for additional plans or for moditieation and list.ARis et coll. I1974 1975. 1976) and Kist & new plans if the implant was changed. The program HILARis t 1975). is run on a PDP-il/40 computer from a Tektronix Tumor and normal tiwue doses from an implant graphies terminal. A Versatee printer plotter is used are sensitive to source geometry because of the for hardcopy alphanumerie output and the isodose localized distribution of Jose from each seed. Al-distributions are plotted on a Houston Instruments - though some of these implants can be approsimated pen olotter. by models each implant is unique and, in general. The program manipulates seed information in requires a dose cateulation based on the actual units of

• ribbons', although this term is not appli-source contiguration. In principle, dose distributions cable to '"I sources. Each ribbon is detined by the of an implant could be calculated by hand from the user and may have from I to.4X) seeds; therefore. a distribution of the individual seeds: howeser, in ribbon may consist of a single seed an actual ribbon practice, hand calculations for doses at more than a

("':Irt, an eatiu ;iane. or esen the entire implant. few points are impractical. SWVALL & SHALEK .\\ll seeds in a given ribbon have the same activity; il972t hase summarized the computer metheds used howeser, the activity of the seeds in ditTerent rib- - for all types of interstitial and intraeavitary dosime. bons may be ditTerent. The souree coordinates are entered in groups by ribbon. try. When the sonic digiti 7er is used for computer in-put. the origms and ases of the films need be entered .\\laterial and Methods - only once. They can be re-entered if the films have .\\n interactive computer program for computation of dose' distributions from radioactive seed implants. Suommed for ruNicanon.m Juh tro 4 M m

42

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seed i t e.;. w I tsa s...i l Ir 0 to too 30 mg g AP VtEW 2 2 ciifs in 0'incons .y fAANSVEASE $nd coorenates 9"" ste so Oms ,F *. & WEW farget Er" n' stance *120 cm Osos.u ownt anme 8 m grees

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CA Change activity of a rsebon-tvos rumeer f# 6 LS List tne seeds--tvoe rieoon nurrber iO = sin f. 85 7<mt tr e suas on ene versatee l,j eS ..hge a s.ted-type aumcee ..t. Y 'I 'D ust fr e wikiose paarnt t 4 TER AL VtEW OP Deiste a pian--type m.moer AP Ast a pian .'z CO Io"h" 'e *'t "w uneau t on EPs te prograan u -- _..y..- outen N-~-. 'a 1 np 1. Etoente..=ndinate miem. Ilie 4.ual.ud planes of Fig. 2. \\l.un display inf the program. A summary of the nupt.i l ukui. tion Jubunny planes..f eaknLuson are speetfied '*> the with. hst of comm.utd opuons. %me or trte iTuons gise mo l etnudimites of three poims tslause to thi coerdiniate franie. Jet.nled informauon esbout the implant. heen moved between digitizing ribbons. The number whose coordinates are given using the patient unu - of seeds in a ribbon is entered at the keyboard and dinate frame. The location of the coordinate ',)stes the number entered via the digitizer is checked origin is arbitrary. However, the y-atis and the 1 against the number expected. position of the origin must be the same on both film For "*lr ',eeds the actisity of each seed is entered of an orthogonal or stereo pair. in equivalent mg of radium. 'Ihe program then com-The implant films are taken on a Picker isocent i pute3 a dose rate distribution in G !h. The Jose rate simulator. For orthogonal films the isocenter i 3 at i em in tissue is calculated from the gamma factor placed at the center of the implant. Antero-posterio and f. factor to t'e 0.0792 Gy!mg h (7.92 radi. Doses and lateral films are exposed sequentially by rotatim at all other points are calculated using the inserse the unit. The magnitientions are computed from ths square law. source.to-axis and source-to tilm distances. For ob The activity of '#1 seeds is enteied in NIBq. The raining stereo films. the patient is placed on a sur do',e rate as a function of distanee in GyimCikh is port frame with a 3 pace in it for the film ' cassette tabulated from the graph gisen by ANDF.RSON. The The film is located on the table top directly be!ow dose rates at all points are computed from the table the patient. The patient is raised so that the iso-using linear _ interpolation for intermediate salues. center of the machine is set at the film. The cente: Then. because these implanh are permanent. the of the tield is, therefore. the same point in space foi dose rate at each point is multiplied by the mean life both stereo films and is u. sed as the coordinate of'"I (2073.6 he to gise the dose at that ; mint result-origin uhen digitizing the films. Since the-field ing from the total decay of the seeds.. center appears on the films, no additional marker A reference coordinate sprem for all seed posi-is needed. The same displacement angle from thr tions is used based on standard antero-posterior, vertical about the y axis is used for both steret lateral, and transverse iiew, iFig.11. These stand. tilms f> pically. a source.to-111m distance of 120 em ard isodose plans including displacements ' from and a displacement angle of S' are used. the origin. mas h reytie ted directly. Allitrai3 .'itandard a.p., lateral, and tra. verse isoditse-planes of calculation are specilled by three points, plans can be requested by a single command. The w 4-s A.m -. A

4.1 ' d 2 t)mE t)isTulst rioNS von RAnio w rive. SEED istPtANTS origin of the plan may be entered. or the computer CS Change the coordinates of a single seed. will_ use the average value of all the actual seed LP List the isostose plans to be cafeulated on the coordinates. Displacements from the origin can be terminal. The infoimation presented is the specilled to give scetional views. The grid limits plan description, the eoordinates of the three define the area oser which the doses are to be caleu-points de0mng the plane. and the caleulation lated. They may be entered, or the computer will gr id limit s. use grid limits that are at least 2 em greater than DP Delete an isodose plan. the most extreme source coordinates in each diree-AP Add an isosiose plan. I'p to seven isodose tion, rounded otT to the nearest centimeter. plans can be speciGed. Standard antero pos-For both orthogonal and stereo films the y-coor. terior, lateral, and transserse views can be re- 'dinate of a source is independently computed from tiuested b) pecif>ing the option: AP.1.3 and each tilm. An uncertainty in the value. Ay. is then TR respectisely. Arbitrary views can be ob-calculated. This uneenainty is displayed or painted tained h> emeting the coordinates of three in addition to the <ource coordinates. This delta points denning the plane. When standard plans value is useful in determining if the patient moved are speci6ed. the three poin:s defining the substantially between the films or if a digitizing error plane are calculated by the computer and listed occurred. The y-value used for computing isodose with the LPeommand. distributions is the average of the two independent CO Continue on to the calculativa of the isodo3e values. plans. ICarriage return. Terminate the program The main display of the program appears in Fig.1 Two-letter mnemonics are used for 3pecifying com-without calculating an> isodose distributions. mand options. Where a seed. ribbon. or plan number All data ennentl> in the program are sased is required, that number may be entered with the until a new case is entered. command mnemonie. For example. isodose plan number I can be deleted by typing DPI' If the number is omitted the computer.will inue an ap-( nclusiams o propriate prompt..fhe available commands are commented upon as follows: this tieatment planning program is being used routinely for *l and *lr implants. It has been found EN Enter all new information. If an error is en-to be easy to use. For every implant both orthogonal countered in retriesmg the last case. this op-and stereo films are esposed. Whicheser pair is easier to evaluate is used for computer inrut. The tion is automatically invoked. SA Save this case in a permanent Gle. The perma-orthogonal pair is used for adding anatomy to the nent file. intended for statistical or other re-isodose distributions. The automatie choices for tro3pective analysis, will be named accortiing isodose plans make selection ea>> and reduee treat-to the patient's name and the isotope used. ment planning time both by reducing input time and CF Change the Gim factors. The factors changed by reducing errors resulting from incorrect specifi-depend on whether the films are orthogonal or eation of the desired plan. The program is eas;!y stereo. This option will cause a recomputation estendable to other seeds, such as radon and gold. of the actual coordinates and the A) values as the need arises. of the sources. 'DR Delete a ribbon. S U NI N1 A R Y Al< Add'a ribtwm. .CA Change the activity of a nbbon. An interactise treatment planning program for the com. l.S 1.i,1 the seed data on the_ leiminal. The data putation of Jose dntobnuens for 1 and Wir seed im- .are listed by ribiwm with the ribbon actisity plants of up to.W sourees is Jesenbed. The seed eoordi-nates kre entered u ine either the ke3 oard or a some b show n. Such data include t he' tilm com dinates, dMuzer kom either orthogunat or stereo films lhe pro-actual coordinates. and A) for each seed. gram produces a dose matns which can t e displayed and

PS Prmt the seed data on the printer. The same pioned directis or combmed widi thi outpm 4 other

.information as that in the La command is treatment plannmg programs tii pimide composne plans for treatments usine multiple modalities Seedsof different

printed, 1

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- 44 1 1. l<( blW. R. G. l. \\ N F. 5.N D C \\ KE1SEY ,,i astnities can tse sombmed withm a single plan. The pio. - Interstitial radi.ition with iodme 125. I'..nmincrus ined. iltam uses two-letter mnemonies for specih eng the asada. IX q IC6i. 28. bic optiiHis. aminne whish are conunanus for chosamg - Imi J. H..and l'ois t i s N. l.ow eneig) radionuelides 0;.,d;.r.1 anteto po letior, later:il..tnti trann et se pl:uts. l'or per tu.neent inlet slit i.il impi.mtationi \\ me r. .I Roentgenol. Ilh e lu'6.1 *l. - \\1 * :< ilNI N. !! \\ t \\ ! \\ N1..md th- )i ;11 E. J.: Intet sinial " "'d '"' i"" ' "' ""r' ' "b'e ' d ' # """"" "' 'h# '""4 \\l' K N i)W l. I'. Dt i). M E N TS .\\ nn, theias. Nut 2. Itl e l#5 *. J'81 l inesc ?"s estig:::.ons f.es e surg %uted in p.u t by l '.N. % Hi \\b H<l %. l.14 \\ t s i s \\l. T. and GN One u in il. l'ub.te llealth ses sie (irant s Ca.1612" ( ~ \\.14u42. and R.idiation therapy and pelue node dase : ion in the i \\ 2in?! trom.hc N..t onal t.mu; In lonie. til!! W

• uan..get uen t of sancet of the ;nosi.i.e.

\\mes. I Roentgenol.121 i 19?4i. 4.12. Kitt J. H. and Hit sais H.: lodine 123 sourec in interstitial tornos thenip>--clinical and isisilopeal considerations. it E F E R H N U ES Amer. J. Roentgenol.123 i t'875i.163. \\'.; 9 wws I. l.. lbsimetrs for interstuial radiotherapy. Stos\\11 \\l. and Sit \\t i A R. J.: \\ resiew of computer ler; lla:nibook of mien stitial ln ash > thenipy

p. M7 techniques foi dosimetry of interstitial and imracau-Edited by H. S. Ifil.nis. Publishmu Si.ience Group.

tar) radiotheraps. Computer l'rogr. Biomed. 2 il9721. Inc.. \\eton. N!.ns.105 12.; liu em H. S.: Techniques ofinterstitial and intracautars S) H> \\. N! and Frin-x B. H.: Technique of after. loading iadi.nion. Cancer 22 819Mi. 2 interstitial implanis. Radiol. chn. 4h a 'G. 4fx. 9 I i

.l vob. lis, NO. I LOW ENERGY RADIONUCLIDES FOR PERMANENT INTERSTITIAL IMPLASTATIOS* By B. S. HILARIS, M.D., J. H. KIM, M.D.. Pw.D., ad N. TOKITA, M.D. N EW YOR K, N EW YOR K A BsTR ACT: An analysis of IS permanent implants was carried out in an attempt to establish J the efectiveness ofiodine 1:5 as compared with radon ::: and iridium 19:; and to derive dose-response curves for iodine I:5 5 n comparison with i Analysis of the clinical results obtained with iodine I: radon ::: and iridium 19:in selected 2natomical sites demonstrated that iodine 1:5 has a higher therapeutic ratio than the other two radionuclides. A tumor control rate of at least So percent with iodine i:5 mplants micht be ex. i pected after a good geometrical dose distribution, with a planned initial minimum tumor dose of at least 14,oco 2,oco rads. Rapid tumor shrinkage ensures a more or less steady or even increased dose rate over a period of several weeks and im-proves the local tumor control. Tumors with a longer cell cycle are especially susceptible to irradiation with radionuclides oflong half-lives. THE treatment oilocalized cancer by is also important because it determines the permanent interstitial implantation, dose distribution and the protection neces-in our experience,is indicated in two cate-sary for exposed personnel. gories of patients. The first category con. Artificial radionuclides, such as gold 193 sists of patients with relatively small, ac. and iridium 19:, have certain practical ad-cessible cancers amenable to the insertion vantages when compared with radon :::: of radionuclides under local anesthesia, they include greater availability, lower usually on an outpatient basis, providing cost, and, to a certain degree. easier protec-quick and edective local tumor control. tion. A major advance, however, has been The seund category consists of patients the development of low energy iodine 1:5 with intrathoracic or intra-abdominal tu. seeds as a substitute for higher energy ra-mors, still localized, which cannot be re-dionuclides. They markedly reduce the moved because of local extension, because radiation exposure, and' are readily avail-of medical problems, or because their re-able, leading to a renaissance in the use of moval would cause severe functional dis-permanent implantation in cancer manage. ability. ment.2d Several considerations enter into the-The low energy and the low dose rate choice of a radionuclide for permanent im-have raised several dirliculties in attempe-plantation. Some are practical, such as cost, ing to establish optimal dose-response rela-availability, encapsulation problems, and tienships because of the multiplicity of the like. The most important, however, biological factors involved in the response from the biologic point of view,is the half. of normal and neoplastic tissues. life. This determines, together with the The purpose of this report is to present total activity, the dose rate and hence not dose-response data in normal and neoplastic only the treatment time but also the bio-tissues based on our clinical results ob-5 mplantation. i logic efect. The energy of the radionuclide tained after iodine 1:

• Presented at the Fifty seventh Annual Meeting of the American Rabem sectory.fata verde. Paereo Rico.May a-o,19 $.

F em the Departrnent o( Rasanon Therapy. Memorial s:can Kettering Cancer Center. %. Yora. % York. supported in part by Pdhe Health Service Grant ECan3 rom t. e Bureau of Ra6ological Hea:th. Rockede. Marrian.i. f 171

i i <,- B. S. Ilitaris, J. I1. Kim and N. Tokita J"i'". "ca dguration and volume of the implanted .urrr.uu. un sir.Twoo rumor to obtain the total minimal periph-Three hundred and ciehteen patients ~ e.ad rumor dose tTSIPD for each of the with cancer of the prostate or lung, or with iodme ::j study cases. In his repon, metastatic disease in lymph nodes of he t T11PD denotes ene dose delivered to the neck, treated bs inte-stith'! impiantation during the period 19 c through og t were suriaee of the, implanted tumor by com. A selected for this studv. lioth epidermoid plete decay or the radionuclide. assum, g m no changes in the si7e of the imilanted carcinomas and adenocarcinomas were rep. volume: a much higher dose than the one resented. Three radinnuclides were used: radon ::, iridium 19: and iodine :c. specified as TS1PD is received bv the core The method of implantation us'ed at ei the implant. Fi;ture : illustrates the dose Niemorial Hospitalis based on the uniform distribution for such an iodine 1:5 im-distribution of radioactive cources within plant. In this crn s section of a chest, both the rumor volume: the required radioac. the primary lung cancer and the hilar tivity for speciric volumes is obtained by lymph nodes were implanted. Although tiie multiplying the average of the three per. TAIPD is r6,cce rads, the center of the im-pendicular dimensions of the implanted plant has received,12.:co rads. vnhime by a concant of proportionality UU, which for iodine ::5 is 5.u This nes c r.rs method of im;slantation results in a non-e m s y,.,n g s,.cgi.u,,.s sont, umform distribution of the dose, the pe. A tora 1 of q: patients with unresectable riphery of the implanted rumor receivine about halini the dose given to the center o'i metastane eindermoid carcinoma to neck lympli nodes was analyzed in this category. the tumor. The peripheral dose varies ac-AII or, these patients had recurrent or per-cording to the implanted volume, larcer sisting cancer atter a course or external doses being given to smaller volumes.' 1 The computerized dosimeerv svstem de. rr diat on (4,occ-5,cco ra$ s m tour to tive veloped at Slemorial Hospir'al 'routinelv weeksh fonpseven panents, were im-provides isodose contours for each inter'. pl need with mdme i:5; :; paneryts )vith rad n :::: and twelve patients wyh ind-stitial irr. plant.A5 These dosimetric data I"A '9 ; patients implantec with :r,idium were reviewed and compared with the con. 19: had,.m general, larger tumors. Table lists the local tumor control and IODINE - 125 DOSE DISTRIBUTION complications according to the radionuchde P utilized forimplantation. Local control was a denned as complete tumor regression with , @i!. n.pp. m -. no subsequent local recurrence for tour or U // s\\. more months after implantation. The over. 1j all tumor control was 6 pc. cent: the tu-Q,4 3 mor control by iodine t:5 was : percent: Ni+ Td

• a

.~ [ ,j by radon :::,65, percent; and by iridium 7g /,./, \\'.' - _.A3.- 192,58 percent. Tne late comphcanon rate G00 '~, ' ' ' J

• "8 ' ' PC'"' II f*'C'"I' "'d 1 P##"I' 4

respectivelv. L' ate complications in this 8'000 ~ / eroup meluded n..orosis, carond rupture, 16.000 JMPlh u_ 32.000 skm ulcers, and necrosis. - Deca.ds at-the A clinical course ni these patients have been l.u..- i. l.. fine n y : uplant he.!.:stm*nt mn. 1 he '5C

• g*"

C'C# d " U "" S ' " gression rates were more pronounced.'" *he

• .. tai :m+ mum ;vr:pheerai dose.s 16..m raas but mt the er. re ni the inlantoi rumor receives ;:,:ce m

iodine group than the other two groups. rad s.

o v=.

26. so. i I ow Energy Radionuclides for Implantation 13 Figure : shows the pereentage tumor con.

WETAsTAric EPref*MCt0 CJaciscMA udare,~canecsr " " ~ " trol urius the TSIPD obtained by io, dine rLuoa cournoL.. ror!L ~

5 mplantation. The vertical bars corre-i

,,e spond to two standard deviations (95 per-i : ! l cent con 6dence limits). The horizontal bars so- ,4 ------- indicate the dose range. An do percent local control rate was obtained with a TSIPD of f l ; about 14, coo :, coo rads or more. 8 Eo;_ '/ 5 8 a Table in shows the relationship of the im-i planted volume (iodine I:5) :s. the tumor control and complications. Although the g r[ 'i observed di:Terences are not statistically 2 signi6 cant (x =o.4:), the trend is that the ~ to!- ^ smaller the implanted volume, the higher ~i 2 f the local control. No variation was ob. o served in the complication rate and severity ,,',g[caaL]ost t 8 i reasi of compl, cations according to the volume. Complications in this group included ribro. Fic. :. Percentage rumor Control rerst<s TMPD ob. 5 mplantation in patients with i sis (two patients), carotid rupture (one pa-tained by i.x!ine 1: muas:stiC epidermo,d Caremoma to nec'x lymph i tient) 2nd skin necrosis with ulceration nodes. (two patients). The erTect of tumor regression rate on local control is shown in Table ist. The 47 median regression time (days required to reach o percent tumor volume reduction); patients with iodine 1:5 mplants were di-i 3 vided into three groups, according to the again, due to the small samples, the ob. TABLEI METASTATIC EP! DERMOID CARCINOM A; NECK LYMPH NODES: TUMOR CONTROL AND COMPLICATIONS et. RADIONUCLIDES l Tumor Control l Late Complications N RadionuClide i Patients Percent No. Percent j No. { Iodine : 5 l c 34 5 is Radon ::: ? 23 l 65 i 8 3! Iridium 19: 7 l 58 { 5 4: 3: l 56 i 6-18 TAsLE II METAST4TtC Er! DERM 0!D CARCINOM 4; NECE LYMPH NODES lMPL4NTED WITH W;! TUMOR CONTROL AND COMPLICATION et. TUMOR VOLVME Tumor Control Complications h.o. or. a amor Volume j 'C" 9 - Patients No. Percent No. Percent i 35 l se < sc

D 2

t-II-jo I? It j 55 la 6c t ic 53r to 6 4 Total c ,u l 5 t!

fl. S. Hilaris, J. H. Kim and N. Tokita J.u.....,-- r74 TAsLE flI sunviva sc::ncma r woLaurea awcsvuuce '00 uKustitic ErroERuniu esRe:Nou u N ECK Li* MPH NODES; [g* RECRKsiin4 RATE 04. TUuGR CONTt0L S0- '{ N. i \\fedian Regre<sion N.o. Or. Tumor Cuntroi '\\ r 'in day 16 Patients yn, percent h i N 20

E

o s ',

i t. S4 i l \\ \\ \\ = i -t

i-4e ic 3

} g ' l-- \\ i 3i \\ \\

.m -s.,

h s 5 \\ \\ 1 L served di6erences are not statistically sig-8 N 2

• s nincant but the trend indicates that the j-N

,- ::122 s ! shorter the median regression time, the l.Ti-l=;i-l higher the local control. i t> UN R E! ECT 4 SLE C A::CER OF THE LUNG A total of 153 patients with epidermoid l l carcinoma and adenocarcinoma was studied i z 3 4 s naRs antr ?fERsMIAL wA&Nt in this category. Iodine 1:5 was used for 59 patients, radon ::: for 49, iridium 19: for Fic. 3. Percentage turvival of patients with unre. 4-Local control in this group of patients sectable cancer of the lung according to the radio-nuctide wh,ich was usea forimpiantst:en. was defined as complete regression of the implanted tumor as seen on serial chest roentgenograms, with no evidence of re-is eleven months; by radon :::,8 5 months; currence after a four month follow-up pe-and by iridium 19:, seven months. The five riod or ! ster. The over-all tumor control year survivalis 9 6 percent,3 7 percent and rate is 54 percent (Table iv). The tumor 3 3 percent, respectively. 5 s 66 percent; by Figure 4 shows the percentage tumor i control by iodine 1: radon :::,43 percent: and by iridium 192, control n. the TMPD for the patients im-49 percent. The complication rate is : per-planted with iodine 1:5. The vertical bars cent, :: percent and :o percent, respec-correspond to the 95 percent con 6dence tively. limits; the horizontal bars to the dose Figure 3 shows the survival rate, calcu. range. A 7o percent local control rate was obtained with a T. lPD of 6.xo rads or \\ lated by the Berkson Gage method. The median survivalbyiodine ::5 mplantation more;it should be clarided, however, that i T< stE IV - C 4RCINoM 4 oF THE LUNC: TUMOR toNTRoL AND CouPL: CAT 1oNs :t. R ADioNUCLIDES Complications h." " '. Tumor Control H2.!ionue!!Je P2 'i'"'5 No. Percent No. Percent insine i:5 9 4e. M i t.- R.14:un *1: 4')

I 4.1 18 22.o

') to.o Irdium I'); 4y 49 i J4

t

!4 1(i ' 3 ', +

i i a e ) vm. n, n. 1.ow Energy Radionuclides for Implantation 5 a unntstcraeLE cancen or int Lunc 6 trorsermo,e ca une.toenocare:nomas ,p. t rJMCn CCNrROL es roral MINIMAL PERIPMERAL CoSE -s f 10 0 t p T i i I . 90-8 L I d i i i i j F s E sor-l I i i-4' 8 = 40-i I o g g j 2or i l d 1 i i 2 s to i4 is rorAL MINIMAi, PERIPMER AL oosE (M roes) j O i l'ic. 4. Percentage tumor conerni versus TMPD for i. l patients with unresectable cancer of the lors m-N y u~',, p! anted w,ith iodine :25 3 L y-Patients with a TSIPD less than to'ooo Fic. 5. Lamply ois 5y par old patient with an un. l resectable epidermoid carcinoma of the left upper rads have routinely received supplemencarY lobe implanced with indine i:5 external irradiation (4, coo rads in four weeks with standard fractionation). The its longest dimension was found at thora- [ minimum erTective dose required to obtain cotomy in the left upper lobe extending a o percent tumor control with iodine 1:5 into the mediastinum and involving the alone is, therefore, about 14,ooo rads. main left pulmonary artery and peri-l Table v lists tumor control and complica-cardium. The mass was considered unre-l tions r.r the implanted volume for the pa-sectable and was implanted with iodine :5 [ tients treated by iodine :5 mplantation. seeds. The T>lPD was calculated to be l i There is no statistical dirierence in local to,oco rads. Four weeks after implantation, control among the three groups. he received a course of externalirradiation ( Figure 5 s an illustrative case of a lung therapy consisting of 4, coo rads in four i implant in a 59 year old patient with the weeks (:00 rad x:d. Figure 6 shows the diagnosis of epidermoid carcinoma of the same patient eleven months after implanta-l left upper lobe. A mass measuring to cm in tion. Note the marked regression of the T< s t E \\* CARCINoM4 or THE LUNC; IODf VE 1:t IMPi.4NTS: TUMOR CoNTRot. 4%D CottPLIC 4TIONS :'s. TUMOR VnLUME Tumor \\'olume No. or' i /cm ; Patients 8 yo, i p,7,,n, yo, p,7,,ng Less than to o o 6 t r.1o 8 5 ? 63 a o l More than 3: 4A .u ao l l I s ~

i l -6 B. S. Hilaris, J. H. Kim and N. Tokita j.,..... e t.oCALIZf.D C WCER o f TH E PROST 4TE @4' A total or. 33 patients with ch..mcal Stage 4 s and c adenocarcinoma of the prostate ' H" was studied in this category. All of these pat:ents were irnplanted with iodine 1:5 Local control was dedned in this' group of y patients as complete regression of the pal-i. pable prostatic nodule as determined by rectal examination, with no further evi-y

1. '

dence of recurrence during a follow-up pe-DE riod between r8 and 6o months. Local fail. M ' M. ures were de6ned as nodular or diriuse in- ^ duration persisting or reappearing during ' g* the same period of follow-up. j. Figure shows the percentage tumor control u. the TMPD. The response curve is similar to the ones observed in the pre-s ",' 'b ' viousiv discussed sites, but higher. Be- ' the entire prostatic gland is im- ".' ~' ' #' eause planted in this site (Fig. 3), the TMPD represents the minimum dose at the surface Fic. 6. Roentgenogram of the same patient taken of the gland, identidatile on roentgeno. eleven months after impiantation. Note the space grams by surgical clips positioned on the between the radioactive seeds is markedly de-prostatic capsule at the time of implanta-creased. :,ndicatmg rumor regression. tion. The minimum tumor dose (dose around the prostatic malignant nodule) in tumor; the spacing between the radioac-these patients is about 16, coo rads. tive seeds is markedly decreased. This pa-tient is alive and well at this time, six years after implantation. ACENoCaRCINCus CF %E 9"C$rart ,l- ,J: '...n.,:p rvMOR CCNrRC:. es r0Tas u:N w AL PE**P~ER n DCSC m e. M i. j (.7)f: h g "_ 1 S E k.- S 4 r e a,j 4 a M 60-x i 8 '- m% - L1J - W_ ~ +- . 4v A([ y t.? 'M,Y 2Cr

• Z

..& ? Q 2 6 'C to Fic. S. Schematic drawing of implant of prostate r3 Tat u% uat :>ta'o A.-w OCsE s se,, using iodine 1:5 sources. The entire giano is im-F:c.. Percentage run er control rerius TMPD of planted. Surgical cli;s are placed on ene prostatic patients with ajenocarcin,ma..I the prostate im-capsule for later identification vi the gland on in-l planted with :odine ::5 calization toentgenograms. 1 1 i

h v... i t. so. i I.ow Energy lbulinnuclides for implantation 177 Tiste VI %DDOC.4ILC3 %Okt 4 "6 TH E P An57 4TE* IODIN E 1:{ 3 %f Pt.1%TS rumor Control Comgbrions Tamor Voiurnc* %.. vt <em9 Patienr4 g Pera;nt k Percent < 19 11 l 100 C o

o-:rj 3 /,

l 33 di i o l C jo-vs 30 l .s4 I 5 40 24 96 4 17

• Endosed by the a6.m rads iandose contour.

Table vi shows the relationship of tumor volume because the sources approximate control and complications u. the volume each other. We feel that the observed good which received at least 16,0cc rads. The local control rate, despite relatively low diferences in local control rates among the initial dose rates, is due to this phenome-various groups are not statistically signiti-non. It is interesting to note that the tumor cant. The only complications were en-countered in patients with an implanted control rate is higherin the adenocarcinoma volume at least.p em.* They consisted of group than in the epidermoid carcinoma transient proetitis and cystitis, but there (Fig. 9). The reason for this diference is were no ulcerations nor tistulae. not apparent. It may be due to the better spatial dose distribution obtained, in gen-eral, in patients with adenocarcinoma of otscussios The distinct physical advantages of the prostate, making up the larger category 5 ave been described previously.' within the adenocarcinoma group of pa-h iodine 1 Previous analysis has also demonstrated tients. This higher tumor control rate may that iodine 1:5 implants have a higher also be related to the advantages of con-therapeutic ratio than implants with radon tinuous low dose rates in tumors with

or iridium 192.1 The apparently better longer cell cycle times, as pointed out by results with iodine 1:5 were confirmed in the present'studv.

ACEN0 CARCINOMA AND tecERuoto CARCINOMA N"C" C "'#" " m "'*'" "f"'""'t :Osc It has been postulatedt that the superior results of the low enerav :odine i:c seeds as '00 compared with radon'i:: and iriilium 19: L '*l#' are due either to the low dose rate, the con- _, ecL '[~~~i" T"~[ l! tinuous radiation over a long time or a eL p.g,-- g, --, 3 ;' higher radiobiological efectiveness (IllE). 8 g,, ,q - i i In general, a dose rate of Ic s than ten 5

/.om j

l j rads ;ser hour results in minimal cell killing !f / j

f I

i in a proliferating cell system. The initial g dof-t / j dose rate for an indine :5 mplant varies ! i according to the TalPD. Even with a zcL .'u i ? ~ l.ec 6.t e-.5 <","*o*

^ac"'c"'

i. TAIPD of i6,en rads, the dose rate is onlv 7. rads per hour;~ it is dificuit to explain r the cell killing e6cer oisuch a low dose rate. z s io i. is Our recent study' has.hown that there is

• ^' " '5 **"5. ac sr. oc,.. i an increase in the dose rate concomitant ic..,,. Tumne enneroi reesi,s Tst PD int an ; arients ic with shrinkage of the implanted tumor.

wi:n 2Jenocarcinoms an.! cedermokt care: noms.

ip B. S. Hilaris, J. H. Kim and. *, Tokita J m uv. ie N Lamerton and Courtenav,7 Studies of cell

. Hesseuxt, C. K., a,d Cave, P. Dimension i

ii"* kinetics of various types oihuman tumors " " d "F! 'im P ' * * ^ I I"'.,.d 5 * " 'T terstitial impiants. Rad. Bis T4rrary,19M, Indicate that adenocarc:nomas have a 3.,, g longer cell cycle time as measured by ~. H:L4m s, B S., H esssw ge, U. K., sn,2 Hott, doubling time and labelling ndex than do J.G.C!iniesicxrenence =ith onc halfi:ie and epidermnid carcinomas." lo.cnen;y encara da ed rad:" ace've v'urceun Possible eains in RBF. can neither be c2ncer rauiat:<.n therary. Re'<rt, W, 9e, in. ruled out no'r substantiated by the present

4. Hit sais, B. S. Techniques or interst:::al and.

study. he present ch. -mcal data suggest tracavitary radiat on. Cear, icH it. 45-a that a tumor which receives a dose below -n. the minimum eFective dose of about

5. Hit =nts. B. S., Hott, G. J., and Sr. Getu ras, J.

14,000 rads and does not reeress to *o per. Innal Repert. Cancer l'herapy by Interstitial ana [nencavinry Radge n. Project No. EC. ~ cent of the initial size within four to six

• • ";, PHS Bureau m Radi loccal Health, weeks after imIjantation will not reeress Rockville,5td., tc i.

comp!etely. T,nese tumors should receive a 3, gn,, y,,,,,,,a g,,,,,,, 3_ g ya;n,, :3,ou,,, ;n supplementary course of external trradia. interstitiai tumor therapy: clinical and bioiogic tion equiva!cnt to 4,000 rads in inur weeks considerations. Au. J. Rotsicexot., R io. with conventional fractionation; this course Tat 4rv & Nects n Stro., inty, i.v io.t- '4 of external irradiation,iiit is eiven within L '""' I 3 *"d C"" * '" Y U I" six to eight weeks after impla'ntation, will Dose Rate in Stammalian Radiology.0ak accelerate tumor shn. kage, and thus. m. Ridge,Tenn.), iWo rr i.i.t.n n crease the minimal tumor dose, leading to

s. SI4tust E., Cs iv co=4, N.. and Tuniix 4,51.

an improvement in the local tumor control Relationship between growth rate, labelf ng index and histological type 6 tumours. Euror. rate.

7. Cau, i9:3, o,. o5 j

Basil S. Hilaris,51.D.

9. Stow 4x, R. Siemcnal dose distribution com.

Department of Radiation Ther2rF putation service-BRACHY :nterstitial and Stemonal Hospital intracavitary dose computation program. I:75 York Avenue Users Guide, Starch, i974 New York, New York scc:: io. R4xo = LL, G., B *trza, S., Hott, J. G., and L4rCMtix, J. S. Stemorial impiant dosimetry REFERENCES automated system. Computer Prog. Biomed.,

s. Axotasos, L. L. Dosimetry fer interstitisi radia.

1970,i,I17-52. tion. In: Handbook oi Interstitial Brr.:hy. i t, Tontr *, N., Kru, J. H., and Hitin:5 B. Dese-therapy. Chapter six. Pablishing Sciences time. volume cons'.ierations in iodine.iti in. Group, Inc., Acton, Stass.,1975, terstitisi brachytherapy. To be published. r

IODINE 125 SOURCE IN INTERSTITIAL TUMOR THERAPY

• t CLINICAL AND BIOLOGIC CONSIDERATIONS By J. H. KIM, M.D., Pw.D.. and B. HIIARIS, M.D.

N EW YORK, N EW YORK T^nsI INTERSTITIAL cancer therapy is the treatment of a malignant tumor by ra-ruvsicu. enortaries or me.osecuocs diation from encapsulated radioactive esto as sztos rom istri.4xTATion sou-ces placed within the tumor. For the - ~ Radio. T s/: T HVL past 6o years, several encapsulated radio-nuclides (days) (r/me.hr. at i cm.) (cm. Pb) nuclides have been used at htemorial Hospital, New York City for interstitial naaen m:: .;. 8 s.:e i.4 cancer therapy. Radon 22: was used ini-Iridum in: 5 55 o.:4 tially, but since the advent of nuclear re-Iodine:25 60 i.4 <o.cci actors, gold 198 and iridium 192 were used; all these radionuclides have a high energy found unresectable at thoracotomy, gamma radiation. which were implanted either with In 19 5, iodine 1:5 sources, a low energy radon ::: or iodme I:Sseeds. 6 gamma-rsy emitting radionuclide, was introduced as a substitute for radon 22: or sf ATERI A1. AND NIETHoD gold 198 sources. One of the chief ad-cusicu.orr4 vantages in using iodine 1:5 was the reduc-The first group consists of 98 patients tion in exposure to personnel, patients and with metastatic neck lymph nodes im-their families. In Table r, a few selected planter', with iodine 125, radon ::: or phys, cal parameters are given of commonly iridium 19: encapsulated sources during i available radionuclides for interstitial ther-the period of 19 5 to 1972. Stost of these 6 apy, meludmg,todine 125 patients received external irradiation, usu-We have previously presented clinical ally 4,oco rads in 4 weeks, prior to inter-experience, with iodine 1:5 seed implants stitial implantation. The majority of tne in prostatic caremoma and in apical car-metastatic neck lymph nodes were from cinoma of the lung elsewhere." head and neck primary lesions with the This paper presents additional clinical histology of epidermoid carcinomas, data for groups of patients.Thisinforma-The second croup consists of to5 pa-tion was used to estimate the biologic ef-tients with prim'arv unresectable lung car-fects on normal and neoplastic tissues of cinoma, implanted either with radon ::: widely dirTering energies and dose rates of or iodine 1 5 seeds during the period 19 3 6 rad,onu-to 1971. The majority of these pr.tients encapsulated gamma-emitting i clides. were treated with interstitial implansation The 2 groups of patients studied were: only. Supplementary external irradiation

r. Those with metastatic carcinoma in of 4,cco rads in 4 weeks was given to 8 neck lymph nodes implanted with patients because of a poor geometric par-iodine 125, radon ::: or iridium 192 tern of the seed distribution (postoperative encapsulated sources; and irradiation), and to 5 patients because the primary tumor was too large before the

2. Those with primary lung tumors

• Pre =ented ar the Fiftysth Annual \\lectrg of the 4merisan Radium biety. Maui. Itawaii. April st-t$. iv4 From the Department of Itadiar.i Therapy, 5:emorial slaan.Kettering Cancer Center. Nw York, New York.

163

v,. 164 J. H. Kim and B. Hilaris smar, m exploratory thoracotomy (preoperative ir-tien for iodine r15 and radon n: is shown radiation). Most of the patients had a in Figure r. Stage m cancer of tiie lung, as defined by the American Joint Lommittee for Stagmg .g and End Results.

• '"5" " 8" " 8 "" 5 musimov noeEocas METASTArtC.VECK LYMPH XODES Table it shows the over-all results of th The implantation techniaue consists oi

^ local tumor contml rate and of the com-3 steps: plication rate in patients treated with First, unloaded stainless steel, i6 gauge iodine 125, radon n: or i needles are inserted into the tumor, spaced local tumor contm r cm. apart. The entire tumor volume is radon :n and iridium 19: were 78 implanted allowing for a i cm. peripheral (38,49), 65 per cent (r5 margin. 3 ) and 58 per 3 Tite second step involves the calculation cent (fr:), while the local complication of the radioactivity required for each im. rates were 17 per cent,,5 per cent and (; per cent, respectively. The local tumor con-plan t. This is done by tue " dimension trol was desned as complete rumor re-averaging" system, in use at Memorial llospital for the past r5 years. The details gression with no subsequent local recur-of the method, as well as the mathematical rence. The early local complications were mostly moist desquamation and occasion-analysis of this system were published ally ulcer and abscesses, usually develop-elsewhere.5 Brictly stated, the : dimensions ing in the firstd months after implantation. can be measured directly with a ruler, The late complications i while the third dimension is estimated by fistulae, ulcers and skin necro the length of the inserted needles. Afte'r averaging the 3 dimensions, the required The average regression rate of the im-activity is obtained by the use of the follow-planted tumors is shown in Figure. It is ing formula: Required Activity (me)= interesting to note that most of the tumors Average Dimension (cm.)XK, where K is implanted with iodine 1:5 seeds reache an empirical factor, specinc for a given the clinical nonpalpable level in a pe radionuci:de. The K for radon :n, iodine corresponding to the one-halflife ofiodine 125 and iridium 19 is to,5, and, respect-r:5 (i.e.,6o. days). The variation of the 5 ively. To find the number of sources gression rate was more pronounced in the needed, the millicurie value is divided by iodine group as compared to the the average activity of sources in stock. group. The third step is to insert the radioactive Table six shows the local tumor control seeds. Several seeds are introduced through rate as a function of the implanted mini mum tumor dose. It can be shown tha: the each needle, using the seed inserter iodine 1:5 implants with a delivery of the spaced no less than o.5 cm. and no more, minimal eH'ective tum than t. . drawn. 5 cm. apart, as each needle is with-rads have a higher therapeutic either radon :n or iridium 192. The dif-ference in the complication rate between oosace cucuurr " orthogonal and stereoradiographs, the 3After the se e the local control rates were equallv high in dimensional isodose distribution within an

mplant is generated by the computerized both groups. The equivalent single' dose (ESD), computed according to n'orthley,"

systems or dosimetry developed at Me. - morial Hospital." A representative dose dis-shows that the ESD of,300 to e,6co rads 5 . tribution from equivalent spatial distribu-is required to control more than so per cent of the implanted rumor, although the i i

Iodine t:5 ource in Interstitial Tumor Therapy t ri3 S vm. sy. m. i ^ A [ N [. \\ ,e / N \\ / / \\, / t" g / + / < L A. .\\ \\ / ~ f I l / / E / l i r / q% L l yn i c.y.. (? f\\ d i / \\ is \\ Mj', \\ 'ud ,/ \\ .MM / t ?.000 maosi 10 DINE-125 RADON-222 Fic. t. Comparative do<e itistributions in tinue (rnm equivaient <parral Jistnbution for iniline i:c and ra ion :::. Implante.1 area: right nec'<, :o seeds anteroposterior projection. Normah/ation: equal dose at cm. per millicurie destroyed. complication rates dider widely (t6 per The local tumor control rates with iodine cent to 46 per cent). and radon <eeds were (q per cent and 45 per cent respectively. This diference was

n. Is na s rei t st. tstet. s s rs or rsa tsixr ms.E statistically signi6 cant at the level of p =c.c3. No signi6 cant di6erence in the

i. ucisosu or rn e s.eso The local tumor control and complica-complication rates was noted. The com-tion rare as we!! as the <>ver-all averat:e plications associated with the implant <

survival time is shown in Table av for were: empyema: septicemia: pulmonary patients whose tumors were implanted hemorrhage: and esophagitis w hen the im-either with radon ::: or iodine t :5 seeds. planted volume was proximal to the Taste II ru nnsin a it. isn i.n r turn srv mn unra.sr s rte curetsnu s i : urx t.vurn sones Iodine :5 Radon ::: Ir;dium te,:

1. Total number of patients 58

6 ta

. \\verace survival in months irnm the time of i implantation 1 1 -:m'

<> (1-:.;l t3 y-44)

3. Number of patients who survived less than 4 months Local tumor control rate in patients surviving 4

4 months or more 4 '4., -s'1 ic :; V: - i : - t s,c I4 = a[t; . f. Complication rate 10 38= (TTh - !" =,;jT*c

• Mgurn in :he parentheses den.ere the r anges si.er.iv :l time.

l 1 t

. gg' : 1 G ,1 166_ J. H. Kim and B. Hilaris Jear, r, r I"" 320 %1on-222

CO -'

,yI n.I n-l' 5: 50h 25r ,g 25r l e i d, c. 6C 90 'CC 20 o 20 .:o 60 50 0 .O Coy $ af *er.mCICMcDoe Ftc. 2. The rate of the implanted rumor regression as a function of days. The horizontal bar denotes the ranges of the days. esophagus. The average tumor volume was oiset:ssion larg:r in the pulmonary group than in the There are distinct physical advantages of neck lymph node groups. iodine 1:5 :ources as a radon ::: or gold The cumulative survival for this group r93 substitute for interstitial implantation of patients is shown in Figure 3, calculated of malignant tumors. Shielding for iodine by the 13erkson. Gage method. The 5 year 125 seeds is easily constructed and light-cumulative survival with iodine 125 im-weight, mainly because of low energy plants is 12 5 per cent and with radon 2:a gamma radiation. No external h=ards to implants, 4 per cent. It is interesting to other patients or personnel exist, since the note that the local tumor control rate after radiation within the implanted tumors a delivery of the minimal erfective tumor rapidly attenuates. Furthermore, the use dose of 16,cco rads from iod:nc 1:5 sources of the manual afterloading of the seeds in this group of patients is comparable drastically reduces the rad!ation exposure with that obtained from the previous to the medical and p.tramedical personnel. 5 nclude i Group I patients (Table v). Other advantages of the iodine I: TAat.s!!! Tt,* Mon coNTaoL RATE 4s 4.FLTNCT!oN or rt: Mot Dose ' thletastatic Neck Lymph Nodes) "jr " se ESD Tumor Control Ccmpiication RaJioactive T (rad) l r rad) iPer Cent) -tPer Cent) Seeds i IodineI:j

4. coo t,325

(soc) oi: (op 8.mo j

.65o 9/t4 (64) i

.14 (14)

$ jt tit) 5/jt (!6)

/ t's,0cc 5.joo

(sco) l I: i5o) l

. coo t o, t.'co j

f Radon ::: 4.:co

.Sco 4,tc (40) t L t; to (te) 6, xo 5,6co tr/tj tif) 6f tj t46)

Iridium 19: d.oco

oo J -4 (5c)-

6 (.;j)'

3. coo c6 t6-F

/6 tu)

6,oco o

ESD= e.p.iv.ilent sim;!e Jo,e. s

,s.. r- .a.. c 167 Iodine I:s Source in Interstitial Tumor Therapy va. m, No. i Tsuts V 5 TU'. tot CONTROL RATE As A FUNCTroN n0[ \\ , j or TtninR no<E t 'nresectai>le Carcincima of the Larg) t -{ -i N i Minimum Tumor Control - Raa..roactive .." *"' g (Per Cent) 3 20p todine group Seeds trad) (n= 47) 2 2 i .( 6, !4 (4j) f r3 .) lodine 1:3 8,000 I to. coo

6/jt U4) p ]

~ '~i Rn group \\ I C' M M 3' N" " * *

• i 6

(n=50) t anatomic sites discussed in this paper. For t example, the results with the iodine I:5 I g' seed imp'ints in prostatic carcinoma and in apic.,arcinoma of the lung show that

hiuh local cure rates can be obtained.*3 i

3 lhe optimum total m,mimum tumor n . Years per Lmplants dose with iodine seeds was found to be in the range of 16, coo rads for the average Fic. J. The cumulative per cent survival of patient, size implant; 2 5 cm. to 4 cm. average dt-with unresectable non-apical cancer of the lung. ). implantel either with ioiline :; scetis i.e with mension (Table tit). The normal tissue ra,lon ::: see.ls, tolerance to this dose has been quite sat. isfactory, although the equivalent single better dose distribution of implanted seeds dose (F.SD) was estimated to be 5 3:o to irregularly shaped tumor volumes (Fig. rads. The computation of the ESD does t), and a long halflife of the radionuclide not take into consideration time factors (Table t), which simplities the problem of other than the recovery time from the availability, especially on short notice. sublethat radiation damage. In addition to the physical advantages, The apparent. superior results with our present clinical data indicate that im-imiine I:3 -implants over other radionu-have a higher thera-. clides remain to be contirmed by additional plants with iodine 1:5 reutic ratio than with radon or iridium, clinical work. The radiobiologic basis for This efective local tumor control is not such a superiority, if present, also requires limited oaly to the malignant tumors and study. Among many possible factors, three I Taste IV 1NTERsTITItL !>tPLANTs o r UNRESECT 4 SLE CARCtNohf A or T54E LUNG i Radon :: i Iodinet:5 (1965-t9 j) 6 6 (19 3-ig68) i

t. Total number ciimplants

!j 5:

. Over.ad average survivalin months from initial therapy *

(t-6-) t t6 ( -6 )t 3

J. Ember id patients survive.1 len than 4 months i t5 i c

4. Local tumor controi rate in patients surviving 4 months or more '

t j$ = 45"c 3: 45=e e ~ C~

f. Complication rate '

f ;3 = I ',"c c qj = t t c

• Fxt. ted tne imerediare poirore 3dve deatn ;roi.rts 3 panents in iodine and i in r:4ca t.

t 1.ight panicits. G. live ;*Lanc i:e n i ptitur aine iradun attt Fipires in ;.nenthe es are the rangs alche *urvival rinne. ~ ,.r. o

y t 4. f t68 J. H. Kim and B. Hila.-is J-u, i,n principal explanations might be advanced rate of about :o per cen't higher than the to account for the efectiveness of the initial rate. The initial do<e rate varies in iodine implants. These are: (a) low dose the range of a minimum of 7 rads hour . rate; (b) a sustained continuous irradiation; (the total dose of iMeo rads) up to an in. and (c) a possible high RBE oitow energy rinitely higher dose rate i.e., the dose in the gamma radiation from the iodine seeds. core of the implanted tumor). Continuous Theoretical advantages of protracted, low-irradiation apparently has some theoretic dose rate irradiation from sources havine advantaue over the acute fractionated long half lives have been postulated by therapy in a situation where the cellular ~ Cohen.2 fle based the therapeutic advan-proliferative activity widely varies. The tage with perm:. rent implants having ong work by Brown rt al.' indicates that the l half lives primarily on the diferentiat re-eriicacy of treatment by continuous irradia-covery rates between tumor and normal tion is little altered by a drastic change in tissues, derived from the isoedect data on the proliferation of cells, while acute, frac-the skin tolerance dose and the tumor tionated therapy strongly depends on the lethal dose of skin cancers. An additional cellular proliferative rate.' advantage of low dose rate irradiation The RBE of the iodine r:5 seeds is at might stem from a lower oxygen depen-present undetermined. Judging from the dency. Several ell culture studies have LET spectrum of the gamma rays of shown that the low dose rate irradiation iodine I:5, it might be assumed that the (30-6c rads hour) significantly reduces the RBE of the seeds would be slightly higher oxygen enhancement ratio (OER).t* The than i and less than i.5. Obviously, more reasons for this are not known at the pres-cellular radiobiologic studies are needed to ent time. Indeed, the magnitude of the answer this question. OER reduction appears to be comparable with that obtained with neutron sources.2 5 coxcixston m em A reduction in the OER is considered to be therapeutically advantageous, because the Our clinical experience with interstitial hypoxic cells in tumors are thought to be tumor therapy is presented in ' groups' of responsible for local failure due to their patients: 98 patients with metastatic car-high radioresistance. Cecondly, continuous cinoma in neck lymph nodes implanted irradiation may be ai important radiobio-with iodine t:5, iridium 19: or radon ::: logic variable. The recent clinical experi-encapsulated sources, and 105 patients ence of Pierquin) with low dose rate tele-with primary unresectable lung tumors, therapy suggests that continuous, low dose which were implanted either with radon rate irradiation to a relatively large volume ::: or iodine I:5 seeds. has led to a dramatic reduction in tumor The local tumor control rates with iodine size. Whether this anparent high thera-123, radon :: and iridium 19: were -8 peutic efect is due to continuous irradia-per cent (3 49),65 per cent (15 ':,) and 8 tion, to a low dose rate efect, or both, re-58 per cent (7/t :), while the local compli-mains to be solved. The initial dose rate of catio-

s were 17 per cent,35 per cent iodine implants is usually maintained at and.,

cent, respectively. An analysis . lea'st up to the first so days after the im. of the aor control rate as a function of. plant. This e6ect results from the fact that the implanted tumor dose shows that the iodinc t:5 mplants with a delivery of the i the implanted volume is reduced en ge per cent in the first month (Fig. :), 'and that minimal e6ective tumor dose of r6, coo rads-the originally spaced sources come closer have a higher therapeutic efect than either rogethtr, even though t_he isotope decays. radon ::: or iridium r92. The results of Indeed, more than half of the implanted the patients with unresectable lung rumors tumor is eximed to irradiation at a dose similarly show that the implants with

.m (.;*' 'Icdine 125 ource in Interstitial Tumor Therapy 16c; S v... n3. w._ i ed!s ir aJiated with c difornium and -adium iodine 12t sources are superior to those with 500fC'8 Nddi* "C' '9" '- C41'-' li e E. I., ih m om, J. 's., and a b in.i. R. tadon ' :3. 15e adyantages could stem from the Extreme' heraxia: its efect on survival of ' better spatial dose distnbutton, and ; rom mammalian' ce!!s irradiated at high and low radiobiologic considerations associated with .iose. rates. Brit. 7. Radial., roo6.Jo,3::-;. Iow dose rates, continuous irradiation, and

5. HENsCHKE, U. K., and Cerc, P. Dimension 2Ver8 sins.simpic method for dosimetry oi possibly gains in RBF..

meerstitial :mplants. Rad. Be,or. Tnerapy,1968, The present ch..nical data clearly demon- ,,, g _ g, strate tnat todine I:5 seeds have a higher .;. Un.sais, n. s., ra osnx e., R. K., Stau ss, therapeutic ratio than radon 222 seeds. G. D., ansi llexscune. U. K. fr.tererial ir. raJLtion of ap;eal lung cancer. Radiofg. - There are, in additi.on, distinct physical '9 8 * ^FF **- advantages makingiodine.i:t an attractive . Hu.uts, B. ').., Wairunas, W. I.. Il=Tara, substitute for r;adon 21 for the interstittal

11. A., and Ga msrain, H. Radical radiation implantatmn of mal,ignant tumors.

and pelvic node dissection in cancer of pros. tate. To be published. A. Nias, A.11..W., Ilmn nii,.\\., Ga sco., D., and J. H. Kim, Al.D. Depa tm nt nf Ra.liation Therapy St yon, D. Resemw -oi Chinese hamster . lemorial Sloan.Kettering Cancer Center (ovarvi ceits to Protexted irradiation from \\ New York, New 1*ork ico:t uCi and **Co. Br r. 7. Radio /., so :,./o, e,c,r-995 p NraSation 9 En yts, et erent REFERENCES continue sou semicontinue) a raihie deb,it des

1. flaows, B. W., Tsosensox, J. R., BranLEv.

carcinomes spidermoides..../c ra.lial.,.l*//u. 7 T. B., Scir, H., and W Tucas, H. R. Theo. trol. et de mid. nuci/arri., ro o, Jr, 5;,-5,36 retical consi.terations of dose rate factors in. t o. R Axori.t., G., B 4t.rza, S., Hot.7, J. G., an.1 riuencing ra,liation strategy. Ra !!blogy, to 3, l.4i c.Hi.ts, J. S. Alemorial implane dosimetry automated system. Ccmputer Prog. Biomed., tro, t9 -::1. ic:, i, i ;T-s p.

. Conex, L Clinical radiation dosage.111. Bio.

t t. Woatar.EY, B. W. DOsafe prescription in radio. logical factor in radon and isotope dosage. therapy using sliJe. rule based on dose time Brit. 7. R.rdio/.. t95o,1), 25-:. fractionation relationships.'.f:ntra!!an Radici.,

3. D oaoJEvic, B., Axotasos, L L and Kru, JS. II. Oxygen enhancement ratics in Heb inM, ti, :6o- ;o.

Reprinted from Tine American Journal of Roentgenoloty Radium Tistrapy and Nuclear Sfedicine l Volume 123 No. I. January,1975 .. n. t.E

v..#

I I-

4 Sp cing n2msgraph fer int rctitici impi nta cf 12sl c=da lowell L. Anderson Department of Medical Physses. Memoria: Sloan.Kettenns Cancer Center..%ew York. New Yorie 1002I iRecened D February IC$) Permanent implants of Wi seeds at Memortal Sloan Kettering Cancer Center are performed by the method of" dimension averaging" to determine the rotal activity to be implanted that is, the activity (in mci) is taken to be fine times the average dimension (in cm) of the target region. A nomegraph has recently eeen developed to permit a rapid calculation of the seed spacing required for a uniform distnbution of the number of seeds specified by dimension averaging. The number of seeds is also given by the nomograph. The spacing calculation performed with'the nomograph, since it involves the two-thirds power of average dtmension and the one. third power of seed strength, is well beyond the reach of mental anthmetic. Elongation and shape corrections are included. The nemograph spacing result is valid for an equipartition of measured volume among seeds but must be increased by an easily determined factor if penpheral . seeds are considered to define the surface of the target region.

l. INTRODUCTION AND BACKGROUND method. The nomograph to be described was designed primarily to permit a rapid determination of spacing when Premanent interstitial implants of SI seeds have been a unii em distribution of seeds is desired. The determination performed at.TIemorial Sloan.Kettering Cancer Gnter

';i the number of seeds, by dividing total activity by seed Nr more than nine years.t The afterdoading technique strength, is a ! css complicated but. nevertheless. useful -mplo. ed is basically that developed earlier for permanent interstitial implantation of =Rn. Mu, and d2[r seeds.2 Its additional calculation performed by the nomograph.

• one half-life (to.2 days) and low photon energy (23 kev tveragei rive mi distinct advantages related to radiation II. OPERATION OF NOMOGRAPH protection and source availabilitv.8 In a companson ni

~ The use of the nomograph is illustrated in Fig. I for two Asorbed dose distributions for a ziven source con:iguration, representative calculations. In case A. let us assarne that a the do<e from 25I has been shown to have a pattern very . 4e to that of mRn within the implant but to fall oh 3X3X1.3.cm circidar. cylindrical region is to be implanted unii rmly with mi seeds having individual activities ei mch.nore rapidly outside the implanted volume.' As a 0.4 mci. The avera:e dimension is (3+3+ 1.5) 3 = 2.5 cm. rest.:' of these considerations, only mi is now used for this The tirst step is to draw a straight line between 0.4 mci on t3 pe oiimpiant at the Center. the " seed strength" scale and 2.5 cm on the average dimen-The activity to be impianted in a given mi case is de-si n scale. extending the line to point A on the center " tie termined bv the " average dimension" method.' The dimensions $i the region to be implanted are tirst measured, line." Immediately. one may read values of 12.5 mC! from in centimeters. in three mutu.dly perpendicular directions. the " total 2ctivity" scale and of At from the " number of seeds" scale, since the eyiinder diameter is twice its The rithmetic average. M+c:. of these dimensions is - then multip'.ied by a constant. K, to determine the activitv. height, the elongation factor tratio of longest to shortest dimension) is 2. Therefore, a second line is drawn from in millicaries, for implantation. For mt seeds, the value P" int A through the value 2 on the cyiinder eb.ngation K =5 h been selceed emoiricallt on the bs of dinical eperience ' The method is defensible clinica:iv in that factor scale *a an intercept un the spacing scale. from which -ma!!er. p itentiady m..re curatie lesions are treated to we read a spacing of 0.7 cm. m.m d. ses wh!!c arzer :esiens. :enera!iv more vuinerabie In case B. U o.mCt mI seeds are to 'ce used to impiant .o a.npkui. ns, are t reatoi t.. Iower.l.~s. \\toreover uniformly a oX3X4.cm eilipsoidai recion, for which the

he saiculation,f auivity by this method requires no average dimension is,n+u 3 = 3 cm and the elongation facor is 11 The :ine drawn front R6. mci seed strength accm a a ape.ial tc.b:e and is eW!v p riormtd menta;te the "peratin; sim immediately prior 'o 'he imp: ant throceh 23. mci total activity ca.is for 42 seeds to be imphnted. From its 'aeginninz at point B on the n,e S,ne.

ar.cedure. he -econd !ine erends threugh an elom:2 tion fador of 1.3 In..d.:ition,, the total au tvity, b.o ever. the therap;st v w is:.<now i, how mar.y 3eeds to imp! nt and lii how 'n the spheroid sca;e t > 2 required spacing of 1.13 cm..'ote N ar p..rt to space them, in order to shieve...!c3 ire,i.113 hat the spher tid wa'e was used even though the reginn is

hution of seeds througho t the de:ined region. The need not a spheroid. For both spheroids and circu!ar cylinders.

wn..i the three dimensions are equal. It will be snown that M a\\. iate.hese quanti: es ~ight tend to nu!!iit tne . cant-ce "i simpiicity.uivr icd by the averaee dimension

ne error involved in using the "two. dimensional" elengs-48 38 Medical Physics. Vol. 3, No.1. JanJFeb.1975 Copyright D 1978 Am. Assoc. Phys. Med.

w.

49 o Ng Lowell L. Anoerson: I:nplants of *1 seeds a cubic lattice within the region: ,.* gro wacc spac.uc ",y'".,,,,,, *'7" ['" u,= (r,6K)lf d.ial. .(n. ac~, 5"(a f,'. Similarly, for a cylindrical region, the spacin: is { "- u,= (wr4K)lf,d.la. (D s -e n [ g

g.. s

o-.

3't -N E! IV. DEVELOPMENT a - *A b In designing the nomograph of Fig. I to solve the prob!em 1 '27 *, ' \\ cure = 7: w 8 ecta of Eq. (6), the multiplication of the three f.tetors is sepa-37 /s N e- ,, [ to.N f rated into two steps. The 6rst step is performed on the left sa I" hand side of the nomograph and involves " salving" f ar an _N'T j %. -$\\ j intermediate variable, t, desned as m-.o p t = d. tai, (3)

• ~ N-SQ

/ f -.c N [ which is associated with an unspecised scale on the nomo- -u oo-m- 4 _.,e graph tie line. The calculation is completed on the right. hand oi ao--u . ?l. side by evaluating the expression 3. u,= (r: 6K)tf,t. (9) { n b The selection of appropriate scale factors (in logarithmic units per unit distance along each scale) ar.d relative dis-Fro. 1. "*I seed.spacir.g noregraoh with lines drawn to illustrate tance between scales is based on repeated application of. calMation of number of seeds and wed. pacing for cases involving the equation for an elementai nomograph, as described in seed strengths and average d.mensions of G 4 mLi and 2.5 cm for case tne Append.tx. A and 0.6 mci and 5.0 cm for case B. For operational simplicity, the scale corresponding to the elongation correction, f,, has been replaced on the nomo-tion correction for ellipsoids and elliptical cylinders is graph by the functionally related scale of the e!ongation inconsequential. factor, r, the ratio of longest to shortest dimension. For this desnition of r, the function f,(r) is given by lit. THEORY f, = 3rl '(2r+ 1) (10) The nomograph evaluates spacing in terms of the average in the case of oblate spheroids and in the case of right ~ dimension, d., the seed strength, a, and an einngstion cor. circular cylinders of length shorter than diameter. For rection, f,. The relationship among these quantities follows directly from the equation for total activity (in mci), Tutt I. Averace elongation correction, f, isee textt as function ot . I = Kd, (1) elen.:stion factor, r, and in comparison with exact c)rrestion. ' abcv d.. and the equation for the volume, either of a spheroid, Relative E:oncanon correction I neati n dirnensions V = (r' 6)/*3d*3 (2) 34k i, Average

factor, r 4/c a

6 e (sh f, or of a Qlinder, V = (r/ 4) /.3d.8 (3) 1.3 1.5 1 1 0.9s 0.9$ 13 1.25 1 0.00 The elongation correction, f,. is assumed to be a function 1.5 1.5 1 0.us 2 2 t 1 0.04 0.05 only of the elongation factor. The value assigned to f, is that required for Eqs. (2) and (3) to represent within a few 2 1.5 1 0.u6 2 2 1 0.95 percent the actual volumes of elongated spheroids (or ellipsoids) and circular (or elliptical) cylinders. For the 2.5 2.3 1 1 0 9u 0.91 23 1.5 0.03 value f,= 1, Eq. (2) gives the volume of a sphere of diameter d., and F.q. (3) gives the vohime of a right circular cylinder. j, [ ~ The volume allocated to each seed is 3 3 t 1 0.57 0.88

= Val.l.

(4) 3 1.5 t 0.00 3 2 1 0.o! Substituting for.1 from (1) and for P from (2), the volume 3 3 _t o.go 4 4 g g op 4g per *ced for a spheroidal region is 4 2 1 0.36 r,=(rioK)f.8d.:a. (5) 4 3 1 n36 4 4 i M4 The spacin;, u,, is taken simply to be the cube rcot of the f volume per seed, under the assumption that the seeds form l Medical Pftysics, Vol. 3. No.1, Jan./Feb.1976 '_j

50 50 Lowell L Anderson: Implants cf "I seeds prolate spheroids and cylinders of length longer than currently being considered in a separate study..Wrenver. I ' diameter, the relationship is the range of values provided by the nomograph scales for seed strength and average dimension should not be taken /, = 3r 4. (r+ 2). (11) as a tacit endorsement of implants mvolving extreme When all three dimensions are diderent, as for ellipsoids in values on these scales. Optimum seed strength and morbidity general and for elliptical cylinders, no exact function f,(r) restrictions on implant volume are clinical questions not yet exists. However, for the purpose of this nomograph, f. entirely resolved. has been desned as the.sverage of (10) and (11). In Table Although the nomograph may be used by drawing line< 1, this average is compared, for represente.tive shapes, with on copies, the working model at this Center is mounted in the exact iongation correction,3abcK(a+Mc), obtained a clear plastic sandwich having a slot cut alone the central by using all three dimensions. The error involved in the tie line. A rotatable plastic cursor with a sing!e ins. ribe icn. Whereas the the spacing must be increased by 0.U2.5 = 280~, from 0.7 scaling coedicients used for slide ru:es redect zenera:iv oniv c ~ to 0.9 cm, if the peripheral seeds are to be v. the surface. t he quantity chance per unit distance on t he scale, :he slaiin: In case B, the corresponding increase would be 1.15 5 =2 5, coeficients for nomographs are induenced as we!! bv dis-from 1.15 to 1.4 cm. This relatively simple adjustment, if tances between scales. Thus, de elemental nomoeraph required, can usually be estimaud mentally with adequate shown in Fic. 2 may be described by the equation accuracy, considering the uncertainties inherent in the actual { I[eq ~.,., "([eq] %. / n moi, , m, placement of the seeds. Q/ /. ] It should be stated also, that the nomograph is not based on any assumptions concerning the absorbed dose delivered by implanted *I seeds, nor does it give any in. in w nich the coedicients of ice, logr., and logn involve the formation about dose. The desimetry vi ul implants is distances m and r between scales as weil as the scate cali-Medical Physics, Vol. 3. No.1. JanJFeb.1976

51 51-Lowell L Anderseau Impiants of '#1 seeds ' --4 Corregonding parameters were determined for Eq. "8..

.i In this case, rante c.,nsiderationa determined 'the choice..i

. _. -... ~ ..s ,J iog w

e. as equal to e., which. ir..m !IM, mean. :c. -.. = - j.

'f Equating coctlicienta again with the modd equation of Fig. 2 yields /.og e. ,ae [(m+ ni n:?:c. e,1 = 1 (18 and f'* ' In mu: .cs= -1. '1" m r. 4 - -- -( a From (tu. the ratio of inter >eale di-tanus is or et = !. r which thes the relative 3cale ta Nr.4, making.:.e ni (!.t at the value e. e,,= !. 'c%. - - - - - ios < The determination..i the number of seeds. X. using the left. hand side of the nonmeraph, involve < the operation ni division, with the quotient appearing. of necessity. on a scale located between the numerator and denominator Fiu 21 Derr. ental nomograph whah m;eht be t.wi. for esampic, ta scales. For identiscation of mrlicients with the equation ni 2btam the vane of the vanable, r,. as enher the pr. dust or the quotient <.f arnitrary pacrs eil tu u mher unat.ne*. :. and n. aoording to the Fie. 2. the division equation is written reistbn Ivgt, = togt,e @ eir + s 1 w h, L - bg n a. - = w:

• i t, k e ogi.I.Id
• Io2' X X**H!oghi a l.

'3h ' Yloittr. r. 6, where n.. u s, and 2, are fat tor-, pre Jpng the numkr of logarithmie units per unit riistan<c on cash. rate. F.quatine coct..: tents yields bration factors.e..m. and e, (in loe units per unit distance L [im-t n. nQ.. evi = 1 (21) Equation f12) is derived by equatine ratios <,i correspondink and sides of similar triangles, that i3 ry m n.;,, c. = - 1. (22: CD BE= f m-n) m, (13) Since 'he requirements ni the 3pacin: ca!cuiation have abady established that :c i z.= -{, the rdative distances and hv substituting for the distances CD and HE in terms between scale

• here, from (22., are ziven by n m = j.

of variables and scale factors. Since (12) mav Le solved for which may be substituted in (21) to get the relative scale any one of the three variables in terms of Ihe vther two. factor for X. namely, ev.e =.* i - the " answer" may appear on any one of the three scales. The values associated with 1, X,./.a. i, and un corre. In the caption to Fig. 2, for example, the equation has been .spond to the intersections of any straight. horizontal !!ne - solved for r, to illustrate more directly two operations (tu with the several scales of the nomocraph and are thus not compute seed spacinen performed in the present application. ur.iquely determined..{ set of such values. however. is Lte that the speci6 cations of muitiplication by a positive requnut in orda to Tua.s re;ative scale ;mtton vertica!!y. coe!1itient and division by a negative coedicient mas be F r the present nomograph. a particular set of apprmi. . changed bv reversing a sc.de and thus changine the si n of mately _mid.seaie values is tne followine. a.=0.5 mci, ~ ~ its scalc iactor, e. L-37.4 seeds. -i-,,,= 3.74 cm. f,..= 0.9 on the sphemid Equation (8) may be written scale, and u.= 0.81 cm. # A nonintecer vah.e of X, if en. logU t.1 = { logai .t,,,r-l i..e t a a.) (14) countered for fewer than about 15 seeds, should be cor. ~ rected for by moving the line to the nearest intecer value of in order to facilitate identiriiati..n of i.c esinnents applied 8 J and acceptine a new value of total activit)., . to d. and a with coetlicients of the equr.tii,n in the caption to Fig. 2.-Thus, ,gg (.,g g, 8t'. K. Hewhb. B :. Mdans. and 6 D. 314h2.. Am J. R.se-t: enol [(m-up m]f t, e.,,3 = j (15)

09. b. Par @

and W i Hilane, t'. K Hen % r.L. an i J. R IMt. Ma R m 41. !103 f n m "t; :>=~{ ll6f .:o a m ivi 'J. & Hoit. B. Hdari+. 5 Italte G D Raen.am. R F Phi 5pa. D..dm.z!15)byIltu pc.ds ano f i L.M.'in. A.- J; Re ve. 4 M W t***.- K Hn6e and P Cew. R.uS,G RaMe 4 14 W

• =~'

't. f", m -'- ni n' ' -' ~ - 'It Huan. a.twe+ :.lin; fer E..!!. ce gy. DHl/A Pts anon D 'FD\\ U '"R nH Daum W i.' s Dr e nef ~ Since the seale factor. is arbitrary, the ratio :.2 ey ms Heai^.. "du r-r inn hia c R.. oi/e. St D *1* D la N t" :he range > vir.g e n.ne.4 ' ee.s..u: asa a $atir g Lwn a o *.r.e suria, s .ac rde.te<. to 1 pre a pratu..u w.. destre's tur a and.!& T..nts rattu has been wt..t :. u.,, = - ? .n3,, y,,,.a 3,.g.y.y,,.3 3.y.,.,,,,,,,3c. g.ny33 in the pre 3.mt n mnenph, with Se nCnn* *gn W re ..en.<p. m : e. ini.m n.er.e.....,..i a.c i m m it. cn acewru fi. the fact that we are "nu.t'pg me naher t nan nve?u:."en e et susou a+eu.'m. e.. oor.e.. r em m.. e y, - divim:q 4 hf shmina'tme the.ign !.tI, rJ'a i i m tn -ds. jnenk 6.,- n..i q<.. r.. m i *. ,4 ,..r u,,-..., n.n .-o 4 . ~ I. 4.., s uh ' na.ug,% van * }.cr;n{ in the. ;ua'..p.. I t vah.e m 21.f, the relau ce datans.c octween e:.u are ;res 1 amWi um avw.ne t. i 9.e 6.e.m-onk. t a "r M "* 2[ negr te f i..t t. usua ti-i

Medical Physics,' Vol. 3..No.1 JanJFet. l1976 -

~ f

.l:. g,p-Dcss Distribu!!ca Around an 12s! Sead Source in

w :r r i:SSue '

v. Krishnsswamy, Ph.c.

5 CGso 0:0:r.bson 000.4 sn 431 source.a tissue has bden ca:Cuia:dd using aGsotDed t.Oss cons: ant eno pc.nt is0:rc;;c sc.Jce 0.i:'as f actors. Se offect of enc 3csuia:;on ma:ctsal has ccen inc!uded. Oc;N:se values have caer. vers!:33 by r",easuremar4s w;m normo. Ianfr.ascant dos;mc:ar:. Prescr4 :::a gNes a va'aJ ICr GbsOr:cd Cose Constar4 of 1,32 ca0s cm /mC:-nr. ccmpere :o :ne pre:er4q used va: a of 1.7. Oc;:n cosa val.as are com;stod 2 witr. c:het published data. AcEx TEaus: Oosime:ty,:hcra;os 3cra;adera::c:agy,rae:snuct;de Rad:o:ogy 126.449-491.Febr ery 1978 4 1257. A CHARACTERIST;C x-ray-ar.d gamma.rsy-eml::!nQ e D'25 0'" 0" O c5m i rad:couctide, is presently ceing used Like raden and $i 0 'O $cj;s 7,got j, other inters:!:ial sources for permanent implants in ra. m ,u a dic:r.arapy.1:s reta !vely :ong ha:f-;ife of 50 days makes \\ / k T~ hs. % it convenient to s:cre, wni!e !!s ;cw-onergy em.'ssions re. t. qu're minimal pec:ec:!cn (1. 5).1:s depm-dose c:stribu: ice. ' O.Smm b. d' a In tissue is very c!cse to that of rad;um, making :: s;,.::able t fcr interstitia; radiotherapy, I l i 4.o mm c MATERIALS AND METHOOS" Fig. 1. 0:a; ram :::ws:ca::ng :3o cons: rue::on of the us! scad j# '?5, supp!!ed by the Lawrence Sof: Ray Corpcration of Ca:itcmia is emoodded 'n :wo lor, exchange resin spheres , w;;h a radiographic go!d marker at the center (Fig.1).1: decays by cice:ron capture and gces :s an exci:ed s:ato of taste, emit:ing a 35.5-kev gamma phs:en. E:octron l capture ar.d in:oma! ccr. vers;ca result in the f:nal em:ssico cf x rays of varicus energ;es in the 27-35 neV range (3). energy abscrpScn bu;: cup fae:or for a distance r from :he Libera:eo elec*rons and x rays, with energy levels be:cw source in units of mean free ;ath (giot r)Jand k is the 5 kev, arc abscrted cy the ; anium encapsu!at;en ma:e-conversionfactor'fromkeV oergs.Theattenua:;oncec:fi-rial. The speci!!c gamrna-ray c0nstant for mis rad:cauc:!de cients for striated musc!e were taken from the data given is 1.45 A/hr.-cm mci-". . by Hubbeil(5). 2 Ocse cistribu::on around the 1251 secd source was ob. talned from the point-source data. The two '3'l res*n Calc;;;afian of the Cose Distribution in 7 issue i r spheres were assumed to be 2.5 mm apart. The elfec: of Cose distribu::cn of an 281 source is similar to cesium

anium a :enuation was included in this calculatlco. An (7). The mean energy, as given cy 0;liman and Vcn Cet energy absorpdon coefficient and oblique path iength for Lago (3), has been fcund to be 28.33 kev, ar.d the scurce ti:anium were used (9). Ca:cu;aticas were mace for 5 cm cmits an average of 1.47 x-ray photons fcr every c: sic:e, a:cng :he transverse axis and 5 cm a cng the source axis, n:ntion. "'he l'ose at any l0ca:!on r cm ficm a poin: iso-except for a sma'lsolid ar.gfe suc ended by me go:d sphere

.r,,pic scurce is taken to be inat given by Serger (2) for at the cen er of each source en either side. It is diff;cult :o water eva!us:e :he dose at :hese regicos: measu.~ed dcse values at these pohts am dscussed ;ater. Ocp h doses were ggg O(r) = 100 4 " (*, y.n exp( #ie

• r) S(ytoi r) norma:ized at an expcsure ra:e cf *.45 R/hr.-mci at 1 cm.

from me scurce in air. 7.e ac'!vi:y inside.the resulting seed } where C(r)is the dose rate in reds / mci-hr., Nis the number is termed one equiv3lent millicurie. Tnis assump :cn cf x-ray phc!cos emi :ed per mci source strength. Eis ine elimina cs absorpt!0n of the source and capsufe alcag the mean energyin kev, gonand um are the energy absorp:ica transverse :ength.TAat.E i gives :he ca:cuia:ec de; Nose 1251 source. anc total abscr;:ica cce!!ic!en s in tissue, B'gtoi

• r) is me va!ues for a rni!!icurie-equiva en:

8- ' From the Cc:ar:mont of Racolog/. Hospital of mo Aioort Zinstoin Coilege of Modicine. Brons. New Yoru. Accepted for puct; cal;on in Ju y '377 .v,w 469

Measurcmcats were carricd out using L:F micro-rod Mccsurement cas;me:crs 1 mm in d;ameter ano 6 mm long in a Tellcn Lawrenca Sof: Rcy Corpctsuon gsve the precis:co cf matrix. Frcm :he energy ce;cndance stucy cy Pu;:c (8) an their s:padstdi:stion as i3%. The ac:ivity of the source x-ray beam wi h a 3-mm A; h.v.l. was chcsen for caiibra- /as ch'ecked using x rays with a 3-mm A! h.v.l. (an of fec-

icn. Tnis gives negligible encrgy descodence Icr :hese 125 ) sad an =IL (c_.ec*ron;c lnE dcs; meters wnen comcated w;;h an '25; phc:on spectrum.

1

ive energy very cicsc to s:.uments Limited. Eng! r.d) diagnostic x-r2y cosime:ct.

7, ese dosin e*us wera also ca:ibrated agains ts.e The dosime:ar was cSGbrated agains; a c0!dw;n-t-armor 33;;.> i -Farmer standarc. '.tescurements were made in Secondsr/ tancard, having a correcucn fac:ce fcr 3-mm a Luci:e ;hamcm beccuse me ;ir. ear a::enua::cn coe!!:cian: S A; uv.:. A rays !cr 20 same source to :ne c.x.s of :he f or sir;;;cd masc lc and Lucite di!!er by on!y 5 %. :n add;;;cn, chsmcor. I.,o exis of ina chamber of the ca!.cratcd cc-depm-COsa varia*!aa 02pende sign!';ca..*:.j c. 74 simo:ct was ke;; 30 cm ficm :ne soutca.. 9e signsi-c-The -mm clameter L'.F C0s:matars form a very large cavi:y nc;se rato in Ws sc:up was around 3. This ca:: bra!.cn g ve compared v.ith the ciec:rcn rcngos::he energy abscrbed a valua of 13.1 mci for the sourco ac:.v;;'y and w&s wah;n in 20 cavi:7 :s pic;cedena:10 Ze raSo of the pnc:en mass

• 3% of :ho manufacturcr's vc;u3.

ene7;y ;33c7pg33 coe;;;c; era 3, gepc3;gg m;33 73mg ;3 g va depin-dcsc va;ucs witn.n ::5 % for do;;..s clcser than 3 cm from tha so rca. For ;arger dap hs or rag;cas a:cng, Cep:h-Ccss Measurement wi:n Li= Gosime: the :ength cf the sourca the va;ues were accurate,only 3rs 1 dcs; metry in s ;harncm is dil'lcui beccuse of i:s witin i10%. h,5 Icw-energy radisticas and the energy dependence of the detec: cts ;n this region c! the energy spectrum. Presem ...ecsurements w; h Photographic e,.lm mecsureman:s assume no dependance en energy for L...- The sice of the dcsimeters restricted measuremen; a: diff eren: dcpts lrcm :ho scurce. This cou!d. howcVer. be jusSfled by :he fcc: ma: ;ho :nterscScn peccess is main:/ slang tho lccg;;Ldinct axis and c:cser to the sourca where me absct;dCn by the gc d x-tsy marker resuited in a largo pho:ce!ec:ric ar.d Ccmpica scatter at these energ;cs varia:'on :n :he ese rc:a. Ces:h-acse d;ste:budon in :h:s (10-30 kev) prod ces fess than 10% oncrgy isss. ;t is,. tarefero rchscnap:c :o ass; mc neg;;giclo vstiaGca :n me region was ob:zined by pho:ographic fi;m. Kcdak M I;:m was sandw:ched be:wcen Luc;te sheets. and inc seed

no'cn spec *rai c

s:ribuncn over two mean free ;sms ficm source vias kep; at the center in a small cavity adjacen:

j

he sourca (5 cm).

us: CEPTH OcsE ERA:s/MA Fca A *.'.wCI.Ai5-Ecs.v ALINr ScuacE Cor.fA. NAG A nAc OcA Amc Gets V TACE 1; 0;;;za:e A:cn;:*.a Tranavorse C's:saca From: 3 der.ter of :ne So,.rca C."I)

• an;;h Cf *.4 $0LrCS 0.0 0.5

.0 1.5 2.2 2.5 3.0 3.5 4.3 45 5.0 cm) 5.203

.32G 0.552 C.235 0.*55 0.102 C.; 6 C.044 C.320 0.C 21 0.5 f.900 2.043 G34 0.433 C.265 0.157 0.G33 0.064 0.043 0 C2C 0.02:

.0 1.0 0.550 0.3C3 C.601 0.356 0.215 0.125 0.083 C. CSS 0.C 40 C.C23 0.02G 1.5 0.245 0.270 C.329 C.235 0.160 C.108 0.074 0.051 0.036 C.025 0.G13 2.0 0.125 0.f50 0.135 G.151 0.113 0.082 0.059 C.G42 0.031 0.C22 C.016 2.5 0.07J 0.030 0.103 0.007 0.079 0.C61 0.046 0.C34 c.025 0.C :3 0.014 3.0 0.044' O.C55 '

O.066 0.063 0.054 0.344 0.C35 0.C2 7 0.C21 0.0 :6 G.012-3.5 0.C31

• 0.C32' O.C35 0.C 42 0.C33 0.C32 0.C 26 0.021 0.016 0.013 0.010 4.3 0.022' O.022' O.026' O.32S 0.G26 0.023 0.019 0.016. 0.013. C.C 0 0.006 4.5 0.016*

C.316' O.017' G.0 :9 0.08 0.G 7010.014 0.012 0.010 3.CC8 0.006 5.0 0.010' C.01:* 0.012* 0.012* 0.0 ' 3 C.012 0.011 C.003 0.003 0.005 0.005

• ValbC3 C*,:ut.21 bS ng therrnC:wrniacsCant c0s;matcr5 &ad i.1:ar ofa!.orL i

i:al.caed va:wos were em:rapov.:ed ttvougn ;ncio; s;nic f;;m measuremen:. . e.or CAcu.Arto u.a.vgasvAzo 04pf+0 css OA;A FcA A *.T.WCuA.C.$cuY4(N; NI ScVAcf l a,.. n <...u. OiStar'Ce AiorLG Ifr.r.3.Or$0 A aia CCD:h d S4 ;o E.305/SC!.nr. (cno Ca:cuwec Vc s.eed Measurec/0a;c.4.r.tec 1.32 1.25'

• .C 2 t0 23 C.2
• 5 0.20 1.02 30 0.:02 0.100 0.s 8

. 4.0 0.044 C.C 43 0.03 50 C.0 21 C.022 1.* 5 - = - e. e

~ g ?- a Theineu:.e 4 491 Ra:.ce.gy. .a... CosE O.3rAtcuiron ~ , V 9.126 i CcwAaises on "5 DEPTH Oost VAtuts Fca A 1 TAats ::t: to ihe f;1m. Thin Lucite sheets were used to construc: a 30 Mwcuad-EcuivALENT Souact w inAosaw.; x r wirn 0;xEn 2 X 30 X 30 cm ;;hantom. Relative density distributions were Puouswso DATA ct:sined fcr lines perpondicular to the source axis and at Reference Refcronce Transverse 0. stance t-5 d.fferent d!Mstices ficm te center. The axial dose distri-from :he Cen:er of Present b ;;;on was determined by enrapoin'ing calcu!a:ed values a w u 6 aW de:ermir:ed for peints away frc.'n be sourCO axis in ac-0.5 1.330 1.230 1.5 ".3 7 P ot. This metacd of met.sure. l 0 Cerdance W;*n the densi: mOnt ass'umes no sig!Mficant charige in spec *ral dis *.ribu !On-3 over the region of extrapolation. 2.0 1.140 1.006 1.335 2.5 ?.030 1.006 3.0 0.010 0.534 t.047 3ESUt.TS 4.0 0.704 0.722 0.310 M M 1626 125;gggg TABLE I giVes the dose d!s riDulion around an source obtained from ca:cusation anc some extrapolated points along.the source tengm (va!ues were witin i10 %). !ated values for this specific radlonuclide that has shown TAGLE il shows the comparisen of the calcu!ated values promise in rad:otherapeutic spplica:!cns. with the LIF-measured da:a. There is exce:!ent agreement betwoon the :wo for d.~fferent depths a eng the transverse axis. TAB: E l'! compares the ca!cu!ated re!ativa dep:h-dose 8$*[',j 'f ,gn gg, g,.ge;n, values with other pub lished data' these resti:s show good 1825 Eas: nester Rd. Eronx. New York 10461 agreement witn the v&lues calculated by Anderson (1) using absorbed fraction cata given by erger (2). Mcwever, REFERENCES c tha ccmparison with the rncasured values G.ven by Holt . (4) as shown in TABLE Ill di!!er Ccasiderably. This is prob- - 1 Ancersen Lt.: Desimotry'for interstitial rad;otherapy. [!n! Hraris ably because they used LiF dosimeters only fcr re!ative eS. ee:Hanscoc4 cfin:cr.t;t;aiarachytr.orapy. Acton. Mass Puttshng 1-dose measurement and evalua:ed the expos; re Science Group.1975 2. Ectger MJ: Energ'y deposition in water.by phc:cos from point c Constant by integration; this assumes some ex:rapo!alion isotropic swees.J Nue: Mac Suppt 1:17-25.Feb 1968 beyond depths me:,sured by Lif dosime:ers. When me da:a 3.

i:Iman LT. Von Oer t. age FC: Radionuc:ide decay schemes arc norma'.L'ed to unit absorbed dose at 1 cm, the relative and nuc! ear sarameters.for use in radiation dose est;mation. M;A3 depm-dose values differ by only 8-10 %.Vatues a:cn;:he Pamphre: No. :0.1975 4

Ho;t. JG, Mlaris 3S: Cancer therapy ::y it.terst.tial and stra-30urce leng*h are cons:darably !cwer man the ccrre-C'##'7 '#'C'^ ***';*' " SPh E*PC" EC#3'n Cce'tfic:ents 1873 3 37 s;ond:ng transverse axis values because of a:: sorption in 5. H :::e:: JH: Pnc::n crcss.sec: ices. Attenuatio the gold sphere and the wolded ends. The effec' of this and Encrgy A':ssrpt;on C0eftcients frem to weV to 100 GeV. CCnunifCrmity is probab!y not very significant in an 3C!ual NSAOSqES 29. WasNngton CC. US Govt Print Off.1969 6. Kim JH, ht:aris SS: tacine 125 source in intersttial tumor, c!inical implant.

Perapj. Am J Roont; enol 123:163-169. Jan 1975 7.

Krishnaswamy V. Cose'etstrrout.ons accut "'Cs sources In CCNC:.LS!CN tissue. Rac.o:cgy 10s:181-184. Oct 1972

a. Pa.te xa: A :hcrmsLmines::ence sys:cm !st the truer:cm-parison of a:scr:e::sse ano rac.at:en cua:.:/ of x-rsys eth a nVL of Ocse distribution arou d an '25: ssed scurce has been 01 :o 3 0 mm Ca. Pnys Mc: B:oi 21:215. var :976 n

ca!cutated, measured. sna com;;cred to data present,.y 9. St:rm s. !sraci ni: P oten Cross Sectens frem 1 kev to 100 cvailable in te C: era:ure. It is celieved that mere inde* MeV for Eernents Z = 1 to I = 100.t.os Alamos Sc: ant.nc Las. Nuc' ear

• Oa:a Tab les.Vo: 7. No 6. New York, Aca:em:c Press. June 1970 pindent measurements are needed to confirm the calcu.

hM

Cv,svC xxggQCxxxxx--- %x;x. xx - , ~gCgco :CCCOOOgC ^O g xxx,Cs-- ~xneC.Cv *Cv yxx x xxkx <gx = xx z z xp xx s = x c x+xxxxxxxxxxxp act' cec',yccencee>+ - - ccccc cc66r a sr-- -xx x- -xx vvvCv0vvvsOw xxxxx==xxxxy-u-----xxxxxxxxCvev CxCvv x x C e,x - eCxperx xxx x

• xx vv vovvCs s-vvv+vv v

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r I-125 SEEDS

• An ideal source for permanent interstitial implants.

Providing intense localized x-radiation. Unique handling convenience. 1-125 Seeds are small enough to be implanted Development with a minimum of tissue trauma (they will 1125 Seeds have been developed as a superior pass through a e,17 gauge needle). source for permanent interstitial implants. (1) Earlier sources, such as gold grains or radon seeds, have been limited by radiation exposure t,0. *.",il" !2$g rl,""" - -~ n and scheduling restrictions due to their pene-trating radiations and short half lives. (2) The soft x-rays from lodine-125 are easy to shield, 0.smm( ) @ $ @ { '}l the dose rate is low and the shelf life is approx-

1. 5**

imately 5 weeks. (Table 1.) Figure 1.1-125 Seed design The availability of a safe, convenient brachy. th apy source meets the critical requirements Indications for Use for a treatment technique which can be applied where surgery, chemotherapy or external beam I-125 Seed implants may be indicated when a irradiation are insufficient or inappropriate. tumor has the following characteristics: Unresectable Cl..inical experience, dat.ing from 1965, has Localized shown that 1-125 Seeds are an extremely effec-Size up to 8 cm (150 cc) tive method of del,ivering raciation to a tumor. Slow Growth Rate The potential for obtaining 80% tumor control Low to Moderate Radiosensitivity rate has been demonstrated. (3) (4) The tumor may be superficial, intraabdominal, 1-125 Seeds can extend the capability of a rad.ia-or intrathoracic.1-125 Seeds are commonly tion therapy department. used to treat tumors of the !ung, pancreas,blad-dar, centix, and prostate. The prostate protocol Design is most effective for stage B and early stage C. Active Source

Icdine-125 (5) (Fig. 2)

Radiation Emitted

27-35 kev x rays Half Life

60 days 1125 Seeds are widely used to treat residual Protection-Lead HVL

0.025 mm tumors following the completion of a course of Range Tissue HVL

2cm external radiation. Similarly, many recurrent Format

Titanium capsules tumors may be implanted.

Titanium encapsulation assures good tissue Patient tolerance of the permanent procedure is compatability, and reduces the total self ab-very good. The treatment is therefore frequently sorbsion to approximately 25%. The gold applied to tumors which might otherwise be x ray marker is included to improve visualiza-managed by more traumatic modalities. tion on radiographs. (Fig.1) Half Life Emit:ec Energy Hait value Haif Value (cays) Aloha Beta (Vau.) Gamma Layer ;teaci Layer '!:ssuel C ! 27 35 kev l 0.025 mm. 2cm. lodine-125 60 I none none Indium 192 74 4 j none 670 kev i 300610 key i 45mm. 5 cm. Gota198

2. 7 l cone ! 960 key i 410 key i

45mm. I 6cm. l 70 3260 kev j 92440 kev l 13 mm. l 10 cm. Racon 222 33 l + Table 1. Radionuclides for interstitial implants. J k

3 ( Implant Techniques l-125 Seeds pass through a #17 gauge needle. -.O Most implants have been performed with after-i loading techniques using an inserter attached to O hollow needles. Several devices are manufac-tured for this purpose.The Royal Marsden Gold + Grain Gun will not accept 1 125 Seeds. g Individual seeds may be implanted using the l familiar radon seed implanters. tI I i ~ Absorbable Suture Ribbon Technique in the past, permanent implants have been limited by an inherent difficulty in achieving a precise spatial distribution, as an incorrectly Figure 2. Computer-calculated. isodose curves for p! aced seed could not be retrieved. In 1975 prostate implanted with 19 l-125 Seeds. L.S.R. began supplying 1-125 Seeds contained in an absorbable suture ribbon. (Fig. 3) The ribbon can be sutured directly through 'the tumor, and may be adjusted to obtain the de-sired distribution. The suture is absorbed in Patient Benefits approximately 90 days, leaving an accurately Permanent implants require only a single simple spaced permanent, implant. (7) surgical procedure. Many implants are per-formed under local anesthesia. Hospitalization is minimized and patients avoid the expense, inconvenience and emotional burden of a hos-pital stay or daily visits to radiation therapy I clinics. Hospitalized patients also benefit be-cause the simplified radiation protection require-j',, /' ments frequently eliminate the necessity for i'/ j expensive isolated accomodations. (6) /j/ b[ ~// A major benefit of I-125 Seed implants is the i J lack of morbidity. The procedure is usually quick, seeds are well tolerated by the implanted tissue, and the volume of irradiated tissue is small due to the rapid fall-off outside the f implanted tumor. (Front piece.) Consequently patient discomfort is minimized and compli. Figure 3. 1-125 Seeds in absorbable suture ribbon. cations are considerably less frequent than for other modalities. (3) Permanent implants are usually simpler and The suture pack as supplied is non sterile and re-j faster to execute than removable implants. The I quires gas sterilization before use. risk of infection, surgical complications and radiation exposure are proportionally reduced. Surface Applicators The use of I-125 Seeds does not require complex The success of I-125 Seeds in permanent im-or expensive equipment and the procedure may plants has led to investigations of Iodine 125 in find wide application in technically under-surf ace applicators, particularly for 1.catment of developed areas. interoccular tumors. (8) } i

r Radiation Protection Tumor Regression 1-125 Seeds were developed specifically to mini-The 60 day half life produces another phenom-mize radiation exposure to medical personnel enon which enhances clinical effectiveness. Most during implant procedures. The 30 kev x-rays implanted tumors regress some 50% during the of lodine-125 are highly absorbed by any high first 30 days. As the seeds are contained within Z material while simultaneously maintaining a the tumor, the seeds are drawn closer together. desirable penetration in low Z tissue. In addi-The dose to the remaining viable tumor and tion, exposure is limited by the low specific out-previously anoxic cells may thus be increased put due to the 60 day half life. despite the isotope's decay. Lead HVL = 0.025 mm Dosimetry Gold HVL= 0.01 mm Tissue HVL = 20 mm The percent depth dose within 4 cm of an 1-125 seed follows closely to the inverse square law. A thin lead sheet of only 0.25 mm (0.01") (1) In the regions more than 4 cm from the seed, provides a 99.9% reduction in exposure. Lead tissue attenuation becomes more important and impregnated vinyl is available for gloves or ban-the dose falls off rapidly. (1) Most treatment danges which may be used when handling the planning computer systems provide a program seeds or for shielding incorporated in the dress-specifically for 1-125 seeds. These typically ing of an implanted superficial tumor. incorporate a look up table. When reasonable precautions are taken using The rapid fall off of dose beyond 4 cm from the thin lead wrapping, forceps to handle the periphery of an implant minimizes the volume sources etc., the physician can anticipate re-of surrounding healthy tissue which is irradiated. ceiving very little exposure during an 1-125 The volume irradiated at the 10% level is less Seed implant. (1) than half the. volume irradiated by an equivalent gold grain implant. Radiobiology Recent studies suggest that 1125 Seeds have a A comparison of an 1125 implant with external higher therapeutic ratio than Radon-222 or beam dosimetry shows that an optimum 6 MV, iridium-192. (3) The radiobiological basis for 360* rotation treatment of a prostate would irradiate 10 times the tissue volume that re-this may lie in the time / dose relationship, and in the highly localized soft x radiation. Con. ceives 25% or more of a given tumor dose. tinuous low dose irradiation is known to de-crease the OER. For some tumors the unique The small irradiated volume explains why high time / dose character of lodine-125 may " match" tumor doses have been prescribed for 1-125 seed susceptible cell cycies. implants with minimal problems with normal tissue complications. Low energy x rays produce secondary electrons with ionizing density characteristics similar to it has been noted that the angular distribution high LET sources. (9) This should result in an of radiation around each seed is anisotropic due RBE close to 1.3 and current clinical results to the presence of the goid x-ray marker and the tend to confirm this. (10) weld ends. (11) Crossfiring, tumor regression, and tissue movement combine to reduce the effect of this shadowing. m N [ ./ / 6 MV, 360* rotation, 1125 Seed g I external beam. Rec. prostate implant. / 7 \\ / I tum receives 65% Rectum receives hn only 30% ( 3 \\ tumor dose. \\v[ tumor dose. Ficure 4. Comoarison of prostate trea: ment with external beam vs 1-125 Seed implant. V J

3 r implant Calculation " Dimension Averaging" Definition of " mci" camp. A simple, but surprisingly effective empirical The assay of I-125 Seeds is now stated in mci rule has been developed to calculate.the activity comp. This indicates that the seed behaves required for a given tumor. Clinical experience equivalent to a point source of the stated has shown that the mci implanted is propor-activity. This compensated assay allows the user tional to the average of the three mutually to ignore self absorptiori of approximately 25% within the seed. perpendicular dimensions of the tumor. Activity, mci = 5 x A+B+C mci comp. Absorbed Dose Constant Measurement 3 The bulk of published clinical data originates from Memorial Hospital for Cancer, New York. Seed Spacing Nomograph The clinical doses described are based upon an Dimension Averaging determines the total absorbed dose constant of 1.7 rads / mci ht at activity to be implanted. A nomograph (Fig. 5) 1 cm. This figure has been revised downwards has been developed (12) to permit rapid calcu. as a result of recent measurements to 1.4 r/ mci. lation of the seed spacing required to achieve cm2. (9) uniform distribution of the number of seeds specified by dimension averaging. Fig. 5 shows If dosimetry calculations are made using any two typical cases. In case A, a 3x3x1.5 cm revised values for the absorbed dose content, it cylindrical region is to be implanted with is important that the prescribed doses equivalent seeds of 0.4 mci comp. The Average Dimension to Memorial Hospital protocols are proportion-is (3+3+1.5)/3 = 2.5 cm. Draw a line between ately reduced. 0.4 mci on the Seed Strength Scale and 2.5 cm on Average Dimension Scale. Extension of this line reads 12.5 mci cn the Total Activity Scale suo avtivisc s,4c m smcNars oivessicN - cc., and 31 on the Number of Seeds Scale. An 5-elongation factor (ratio of longest to shortest "7*' 2.,"'( i'"

• Cd 5"5$

Ns dimension) of 3/1.5 = 2 is calculated and an W Z '"

• i

'2 extension from the tie line point A through Elongation Factor 2 to the spacing scale gives N 2 I u 15 O.7 cm seed spacing. The result states that 31 [' ' .i -y L.* seeds of 0.4 mci comp. activity (total activity yt A f'3 ,c:_/, \\ MNGiftCN 12.5 mci comp.) should be implanted at 0.7 cm "C" "2 +- I w intervals. 2~ cs a S**K-/ j,, -w If seeds are implanted on the perimeter of the s. tumor, the spacing must be increased by the ? "1-* a ratio of the calculated spacing / average dimen- "~ sion. In example A the correction is 0.7/2.5 = 53 % The actual spacing would then become dos 1 .o--so { in case B a 6x5x4 ellipsoid is to be implanted 3.3 [ ao ta, [ with 0.6 mci seeds. The average dimension is j + l (6+5+4)/3 = 5 cm, and the elongation factor { is 1.5. Drawing the line from 0.6 mci seed g N strength to 5 cm average dimension shows 42 seeds are required. The Spheroid scale is used for ellipsoids and when a line is drawn from the Figure 5.1-125 Seed Spacing Nomograph (10) tie line at 8 through Elongation Factor 1.5, the t, c ane,,en v,m,i, so,,,,,,, s, yo,. n,,,;nt,o,,,n spacing is shown as 1.15 cm. p.rmmion of Puensning sciences croup inc. i q

r Licensing Quality Assurance in June 1975 the U.S. Nuclear Regulatory All seeds receive x-ray and microscope inspec-Commission classified 1-125 Seeds as a well tion and are individually assayed before ship-established clinical proc 2 dure and added the ment. Seeds are leak tested to assure no.igni-seeds to Group VI of 10 CFR, 35-100. Most ficant removable contamination. All seeds are agreement states have similar regulations. autoclaved prior to final leak test. Initial order must contain verification of appro-priate radioactive materials possession license. Storage Sterilization A principle feature of I 125 Seeds is that a 1125 Seeds are not sterile when shipped. It is physician can order a quantity of seeds and store recommended that autoclave sterilization be them at the hospital. lodine-125 has a 60 day half life and the seeds have a nominal activity of employed. 0.55 mci comp, when shipped. Their shelf life 1-125 Seeds in absorbable suture ribbon should is approximately 5 weeks. This eliminates re-be gas sterilized using ethylene oxide. Other quirements for precise patient scheduling and sterilization methods, such as the steam auto-allows a busy department to hold seeds ready clave, may destroy the suture, for an urgent impla 1t. ' Specifications 1 125 Seeds: Nominal activity - 0.55 mci comp./ seed Seed dimension - 4.5mm x 0.8mm Emission energy 27-35 kev x-rays lodine 126 content - less than 0.5% Worldwide Delivery

• Prices Shipments made 10 days after receipt of an All prices quoted are FOB Sunnyvale, California.

order. (Emergency supplies may be available on 48 hours notice.) Shipment via airfreight, both

• Specifications and prices are subject to change domestic and international.

. without notice. L

3 r g References

1) Use of lodine 125 for Interstitial Implants, Govt. Print O ffico, No.017 015-00C94 0,1975.

2) Hilaris et at: Cancer Vol. 22 p. 745 751,1968. "Techniaues of Interstitial Radiation."

3) Hilans et at: Radiology 126 No.1 p.171 178,1976." Low E wrgy Radionuclides."

Annals Thoracic Surgery 20 No. 5 p. 491-

4) Ha.fis et at:

500,1975, " Interstitial irradiation for Unresectable Carci-noma of the Lung." Am. J. Roentgenology 121 No. 4 p. 832 838,

5) Hilaris et at:

1974," Radiation Therapy and Pelvic Node Dissection in the Management of Cancer of the Prostate."

6) NRCP Reoort no. 37.

Am. J. Roentgenology 124 No. 4 p. 560 564,

7) W.P. Scott:

1975, " Interstitial Therapy Using Absorbaoie Suturing Tech. niques."

8) R. Sealy et al: Brit. J. Radiology 49 p. 55I-554,1976. "The Treatment of opthalmic Tumors witn Low Energy Sources" Interni. J. Radn. Biol. Vol. 23, p. 539-548,

9) Sondura et at:

1975,"RBE of 50 kVp Xrays." Hanobook of interstitial Stachytheracy, edited by

10) The B. S. Hilaris, M.ts. oublished by Publishing Sciences Group Inc., Acton. Mass.1975.

11) Private Communication e.lif ton Ling, Massachusetts General Hospital,1976.

12) Anderson L.L.: Medical Physics Vol. 3, No.1, p. 48 51, 1976, " Spacing Nomograph."

Patents US Patent No. 3351049 British Patent No. 1133219 Canadian Patent No. 830573 For further information write or Call: Lawrence Soft Ray Corporation 1246 Birchwood Drive Sunnyvale, California 94086 (408) 734-8911 I Copyright 1976 Lawrence Sof t Ray Corporation 84e76 i -b

)@p / W Lawrence Soft Ray Corporation 1246 Birchwood Drive Sunnyvale, California 94086 (408) 734-8911 i { l t

' f~ ~ 9 '1 T f' ll7 l' '~1 1 't i)') ,' '. ' $ J K1flV'l1l)l M L-

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1275 v o w <. A V E e u c. N n: w v o se r. New vowA 64021 ? November 3, 19'S J..Ed Barnes, Ph.D. 4270 S. Alton Place Englewood, Cclorado S0111

Dear Ed,

I,am enclosing the I-125 interim reference data we are currently using for clinical dosimetry, as we discussed on the phone this af,ternoon. Sincerely, 7 G c%:.6 Lcwell L. Andersen capartment of Medical, Physics LLA:=b Enclosure 1 l d I l 1 l gr.uc. 4 u wot... ira. Sciec u.cc.< A.a Ai.tita 0.at xsts ' s A ** En . 'e ; 6s fe *. " * '.. l e.' s e ? . gg ?. ", a C **f'fe.

0 I-125 DOSIMETRY CHANGE On July 3, 1978, we began using a new cc=puter reference table in oud clinical dosimetry calculations for I-125 implants. The new table reflects a much closer approximation to absorbed dose, as determined from measurements and calculations now available, than the table ~used previously. 'The nu=crical value of the. matched peripheral dose (MPD) for a given implant, using the new table, 'will be about 65% of that which.would have resulted using the old table. The stated dose at other points will be lower 4 by the same percentage. The actual radiation dose to the patient depends en implanted ~ activity and is unaffected by this change, which concerns only our estimate of the. dose. As before, the dosimetry calculations will serve to intercompare MPD values and geographical coverage among I-125 patients only. Conparison with other.=odalities must await further radiobiological data to delineate RBE and dose rate effects. r O e + 4 o 4 0 0 e 5 w w

e o .n e e .g ....i .i-e,.,....x.. ...n. s a. ... =. .,..4.. ..,.....1.- I.

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.,,. m. u gy - - 1 g e.. 4.;.. = j... Clinical Experience with Long Half-Life 3 E and Low-Energy Encapsulated Radioactive Sources in Cancer Radiation Therapy' 3... I BASIL 3. HILARIS, Nf.D., ULRICH K. HDISCHKE, M.D., Ph.D., ar.d L GARRETT HOLT, A.B. s. i THE TREAT 11ENT of localized cancer 'Oy inuittai-iT2 5,T lxTrtnsr:Trat IMPt. ANTS *a*ITil Taina D Peimam y j Ettus ex ( T REsReT Anf.E W T* l small radioactive sources pennanently 3t.masaxT rnions ' Ale'n"nal t ro-intai. naion2 6 7 placed in the tissue is generally recognized 4 2s an etTective modality of radiation

4

,.y,,, 8 sur. ivors r Serapy. In the past ten years, we had the T. ; opportunity at Memorial Hospital to use various radioisotopes for permanent. Intraoral nm v m-Intrauioracie 4 e4.. ; i I n t ra-a hd""" 1 6 ID C'1 ) terstitial implants in cancer patients. """",'[j',","j'"* ""' M."7$.y [ These radioisotopes may be divided into two groups: those with short half-lives radon 222 Ub days) and gohl 19S (2.7 daysi: and those with long half-lives, seeds is the better radiation protection of l,r iridium 192 (74 days) and iodine 12> the hospital personnel. This is possible be- ,,i) days s. The radioisotopes with long cause the long-life seeds are of much lower

f. l'

alf-lives. iridium 192 and iodine 125, activity at the time of implantation than present a number of practical advantages the short-life seeds.

for pennanent implantation. Tam.c I summarizes our clinical ex-The first advantage is the greater avail-perience with the long-life iridium-192 i. 2bility of the seeds. With radon-222 and seeds. From' October 195ti till January rold-lV5 3eeds. the activity decreases so 19ti2. we used the3e smis in :M per-fapidly that the seeds must be ordered for manent implants in '127 patients. Of the i 2 specilie day and usually have to be dis-327 patients 22 or si.7 per et nt -urvived ctrded if they cannot be used withid a day rive or more years. This was quite unex-or two. This fact limits permanent im-peeted 3ince the hical dkease in most of slants with radon-222 and gohl-19s seeds these patiente was unresectable and niten [a raost hospitals to tumors which can be unsuitable for external irradiation. In .nea3ured accurately before imniantation 219 patients 015 per cent of all patients) i and requires a specitic order for each im-the permanent implants were perionned at plant. In contrast. the decrease in activity thoracotomy or laparotomy. The im-ei iridium-192 and iodine-125 seeds is so planted malignant tumors were considered ([ slow that in practice one shipment of seeds unresectable because of location near vital a, of suitable activity per month is satisfac-organs or vessels, large sue. massive involvement of the regional !ymph nodes. tory.The sceond advantage of the seeds with In approximately half of these 219 pa-1 2 longer half-life is the greater economy. tients. the cancer had recurred after ade-ul Mllong-life seeds which have been received quate x-ray therapy. .\\ partial resection cta usually be used for implants, while of the tumor was pos3ible in only !! pa-1

3ay short life seeds go to waste.

tients. The third advantage of the long life In Tant n II, tl'e results of the per- ' FNin the Department of Rathation t herapy and the Dc;)artment oi Sterlie:.1 I"iysic( Stem.. rial II.4 pit d I, r Gncer aad Aihed Ihwves. We York N Y. Prescuted at the Fif ty thir.I Scient uic h mi.ly :unt Amnial XI.rt- .g..f it:e ka. holo.;: cal doctety of Lrth Amtr:ca. Chicago. Ill.. Le 26 ike. l I"o. Supported m p.srt by P!!S Field lave <tn:ation Grant CA uW9. by Grant CA ds7W fr.au tl+.Gt;onal C.uiu r w(.,;tute. and by C.ntraet L. PH 86-%132 frem the National Center inr Radiol.wical IIcalth of t he Ithlic ,F w m A evice. R..ekvdl.. Afd ,not....mv 91 : ! 1.G-i 167. I'cermlier nM : A.W.!!.) l lei:1 i M f ( i ? l 4 -% E6fw,%.- Ti "l 5

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%/ %. c -,. n ~

1 s T l iNet* " W Hot.r F U. S. Htt.aats. U. K. HENseliKE aND J. Cs. A i16F f 95 per cent con 6dence limits do not sub- [ With 23 P x ? T*, u., i stantiate any sneh ditTer,:nes.. of this type. de5e8 interstitial iutplant [ 1 varying from In.ono to anjiic rads are de-h .. ?-* y .: 4 rye .F h.vered within the. unplanted volume. t 3. dose drops very rapidly. however. outside -s.Aet St% ' ~ the implanted region. reachine insigmneant hp'i.. E levels within a few centimeters. As 2 j. ,'f ./ *"* 1 i. ( g intra-Threi stav.iitir iiiiptantatino of att ee i 3 Fk .l il.nmnal unpf-on a uia it, Inmi 192 -er ls. C f ~..

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I'l M M A NI *. s l $. i l.K> l li l Al. l MPf.a*. 8 4 j 'l Ant.l. !l: . l Al.i..N a.N F INIWAllu.M AGtC ANil '~ i,- \\ IN IS t k A. AnDisMIN At. Teve ens 3- ' \\ lone. ire:.I ll... pit al. I'l.*4 n.62) ,? i . E'. e4f p p'.,,.9.- T -a-ve tr psirtivors ,. ~ g. en ..ry eite innum gg u,,n = [. a___ c .s 4 9.'.L./,i x 162: '. n y_ 1:ntathurac c .1204 2* ; > The same patie t two year. after innptanw . 79 1.v.. n it, Dr..neh. qcmr

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br a-d s.l..minal 6 127 2 7*. I ::ni2 s, ) a ett..,i gin.... i ar result os high tumor doses. consistent regrevion of the implanted tumor is i e n.an> o 2" Tumor regressiM o6 u ac n.an; i :;2 obtained iii.dl patients. i for the long-life radioisotopes and short- 'Ii iY no.ir i i' i 17 oa life isoloIlei simwed no e *.ential dilIeTeU l o i ou 4 t.no r 1 Di i:6 \\u. rainn is to 2Pt 9 178 The sk.m and mucosal reactions. however-g.> r nber P were dednitelv less oronounced with irid .s2 w> . ;.; = i e itun 190 than'with r'adon 222. There is 2 t suggestion. therciore. that the continues m low-do<e rate of implants with tong half-manent implantation with iridium-l92.eeils of malignant unrescetable intrathoracie ] therapeutie

• life seeds holds soine i

and intra-alxiominal tumors are compared vantage in interstitial ra lirtion therapy

• {

with those of radoti-222 seeds.: Of the for cancer. of a 43-year-old patients treated bv interstitial im-The following hietory 219 [ plantation of iridium-192 seeds from 1956 salesman is an exampie of an intra ao-l.1 per centi dominal permanent iridium-192 seed im-to 1962.10 ( 1.6 per cent A l survived live years or more. During the I. 'j same period. Iso patients were treated by plant with long survival. On g g.,,( g_g j raduit-232 implants. Nine 5 per cent = g g, . a rida nephrectomy va. perir.nned. II"i j 1., per centi sttrvived hve years or more. .:vpt n.U..wn! he a right ureteraci..mv and try.F g; .g 1 tatistival analysis of all patients was ar<thral rexenon -n Oct. 2 for 2 ra:"iiary carcine,n nas 3, earried ottt by Dr. David Schottenfeld of of the ri.fu -enal pelvis and right uretera ^n: l C' s In March and Nove* the llepartment of Clinicul Statisties at with spread into the bladder her m'.7 treew resections were e.uried at i it 3demorial Hosp. ital m. order to ascertam u.. In December M for recurrence-in the bladder. .o.nh.ni..n wa,.;iten to the bladdc' f any 4tgmheant ditterence in 1 t here was live year 3urvival for tho.c with iridium-

p. 4..p. i.o n.., to em anterior and ;r.,terior t=e 1

thr,n h 192 interstitial implants and for those "" "ther ini""""d"" "ak'* '- h r ti'F' "" a liosphal 61 the tir-t tune The with radon.222 interstitial implants. cen at W uor i.d it thi4 time 4.r.tn<urei.hral resecdef .\\tarch '"?.i .r h o,..i the r r.-nit is inem.ie.1 h.omi onte n-or an.1 chronic ev-oii-without em i n...... i nr.4 n i .: pi n e.n. enhi, o...n. s s% 2 .a.3 ~ 7._'

1 ~ _ _ _. _ N 1 w/ ENCAPSUI,arED Sot'RCES IN ('ANcElt It AbtATrox TusteAev '.16.*, f Tc"4 n W 41; f found along the right common extcrnal i!iac vessc!s ..D M

• 6

- I jenec ..I no plem. i'n.\\ pol 11...m al l..minal upioration was carried..nl becanw of a reenrrence U.( -, 4.g gem an the right side of the bladder in addition to the 3,'*).y bladder tumor. a matted man of lyniph nodes was St' 2nd in the right obturator fos a wit h inva.* ion..i the NI, -/ N. ~,I : M~~ N liaevrin liiop y di-ch.xd a meta tatic cpidermoid g k nreinuma. The bladder was not opened but ap- / .a l' 3 peared normal on palpation The t um..r we enn-b f-j[ C~ sidered unre>cetable. A peratanent implant was e\\o ' Wrf:t %g. i r# ' g'. e 'Mh 24K Ocid Ball ... A q .022".024" Diam, f.O '

• Ge % '

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v $. l Fie. 4. Intra.abilominal implant with i.wiin.123 [ evd. sh..w m a t he.-. l..-c.h.i rd.ui n.n. 4 t in-r uba. ("'" Dowex 21-K Spheres p?. P.' i .022".024" Diam. the seed makes it vi.ible m. radiographs. Fit 3. Drawmg of the ermnt i. anc.tes wed. L*nfortunately, the present iodine-12.i deeds b. I are still too expensive for wide u-c. but with then done with 95 iridium-n'2 seeds for a tota! of autontated production and lurther im-e .e -. i il mg Ra equiv. and a minimum dose or. H.ono rads 4 within the implanted volume inodes and ri.:h t Provements m the design and construction. g,- bladdct, wall) Figure 1 hows.t lihn of the im. the price whouhl approach that of a radoit 7{ '[ pianted region tlwee day 4 after the implantation. seed. The rado.actwe iridnun sevds can be >cen along the Tautx 111 gise. the total nuttibor of oa-

ht pelvic wa!!. Figure 2 3 hows the implanted re-tients treated by iodine-IST imE ants since l

'en n the saine patient two cear later The seed < da- .>. I.p t o Sept..;U. P.Hi?. a ( 1)ccember 1%.. ge e!-cr t..actla r. in.licating rearts i..n 4 the tunwr. The patient was well without evidence of total of Ol permanent implants with fixa<e and a ymptomatis..n hi-la-t foil..w -up ti-it iodine-115 -cedw were dolic in NI patientw. g' ' l un (2::. 25 ha.., etunt esar and unte months aitor .l.Anf f. Iil: IF R \\f A N r. T l N a ! p i i n g.U. i..in s t. i j,*. 9 l 1.n 1 v. i - i s I m.i. i u s i. \\ f u i... r. r e u..u - n .T b m..e d f lo-i...d. l in. n u..; q,, !!wg Q! l iorttinately. the long-h..ie tridium-lM2 -.g. f( i seeds have the disadvantage of requiring ,: n,. L.4 c:diation.aicty precautions for a prohm.;ed h aeriod at least for the implants with many intramrai y in

n t r a b..r ir.c

.e r,dium-1M2 3ced>.,I,his pros ed to be a real n u r,,. a,a..,m n d y, yl auisance in many situations and obliged us Superic al 44 to start a research program to eliminate or 3 \\'""r 2t least te decrease the radiat:on expo ure A! were carried ont duting h frem the implanted patients. Thirty per cent The most prcmising of the investigated thoracie and abdominal -urgery. Seventy M'.

2diciwtopes appear to be gamma emitters pe cent of the tumors -howed complete

. :. ) ander 30 kev, with iodine l1i being the regression after one implant. and 9.3 per j 4i yl caly one commercially available at present. eent -howed more than 7.o per cent re- .g; Figure 3 shows the pre <ent iodined ii gres< ion. The skin ami muco4al reaction, seed. It con 3iit3 of a thin-walled titanium m ie similar to tlio-e sea when iridimu-g, Q.l

ubing' containing iodine 12.i hound on a

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r { I ~ Figitre 6 lu.u-the hurlantsd area with the iwdo c l di>t ol.u t i..n \\ mininnnn.io c ot 'i. i n a s ra.i a.. l f. ],. ? . o..n !nn - delivered within theimplanted v..lutne 7

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.A' ably well. wuh verv -N;St pcrtpher.d edema att. i being. n hi set i.ut r;o 'imit.iti..n of act.vity. l 3 g In.8 tion.. nil n.. Ut i';are 3vtut et.,lu s Figures 5 : nd si show examples of tumor s k regrewinn and skin reactioni-inlbming itu- !. *,.,,M,? JFf f,/'. F[5s.,.5 Gi*d.c1-plants with iodine 125 seed >. Figure 5 is ei ,p - #.... w' 4 ,x -. g. NW )3.i C. * ' '4 8'. ' '-. a-; %'* * - DEPARTMENT OF RADIATION THERAPY ).c. MONTHLY AVERAGE R401 ATl0N EXPO 5URE IN 140 ~ ia 1:ic r. c.mpis it rnrc k.n.4 inn..< a r..und the 150p trachts.*tenna ihnt ursknufter unplantati us.4 the 'ii'

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~3 j 192 seeds were u-ed provided that iodine-0 'tay My S e-t. w. { 125 seds of 0.5 to 11.7 mci activities were .e an. '.'a r. ] s-employed and that they were > paced 1.0 to pg. ',q p',' 1.5 cm apart. ? n The following hi-tory of a ei:;-year.ohl a :hi-year-ohl female witit the aliagnosis of l[ bank emph yee is an example of au mtra-recurrent carcinoma of the extrinsic larvnx f j, .j abdommal implant with todme-125 seeds. around the tracheostoma treated by ~J5td II. maturia ilevtloped in.Tannary pig. e$n Fth, rads (June 2:1 to Aug. :I. luti?.eith cobalt-pi' a lvit nephr.nreterectomy with excision.4 a cuti 60 gamma raysi. On Sept. 19. 1907, r. 3,* . a i. ..i blad lcr wa-entrito out for a P.rade III tran-i-2.0 X l.0 X 0..) em residual tuass was int-tional evil (arcin..n;a.4 the urettr. In Februarv a nrir. pain and sw eiling of the left leg were no.ed. O' pl nted with. seeds. eac. 1.0.'s mL..t, tom-n puter-calculated total minimum dose was . starch 21. an esp 1.. rat..ry laparotomy di simd a Is F;' hard mass ?.~i X tr, X ' enn lateral to the ter-l12.000 rads. The photograph taken three I f minal portion of aorta completely surrounding the weeks post implantation shows a com-connnon ihue s e st and mvading the p na4 mu-ele ulete regreddion of the tutnor without anV as far out as PuupartN ligament. liionsv revealed a ' kin reaction. g i s r

w. eta tatie epidermoid carcinoma. The' tumor was Figure 6 is a photograph on, a 6.'s-year.oh.

s con 3.dered unre-eetable and wa> imolanted with.b f iodine-IS -ceds for a total activity of 40 :1 mci. male with the dia:;nosis of epidermoid i i j a 1 e i

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inoma of the lung metaitatie to the use of permanent. interstitial implantation I neck treated with-luno rads (from March 7 in cancer management.

to April 4.1967, using the cobalt-60 gamma h[, r ] ravsl. On April 20. a 4 X :1.4 X 1.5-cm Menmnai t ro pit.a for e m.vr ma unot ni-n+- ~ r5idual man in the neck was implanted S.',I,,',f?"['i,,n3 'p nith 15 seeds, each H.7N mci. Calculated M total minimum dose was s.oon rads. The gii.i.gp. g.p3 k'b ahotograph taken rive month-later shows 1. Itcssenwr.. i.. is.a

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complete regression of the tumor. Only a n.-ma n s..u n e...t u..a...... .. c in.nnni na, ne r V"' ld M"- by (.""T. l'ack.uwt 1. "M. Ann.8 '". '"5 "' C^"c" "' Mi 4 "hw \\..r k. Ht.che ?"'S moderate pigmentation can be seen in the e ppraclavicular region, in spite of the h. h i ste nal oivisn.n..( uarn. ri. ;a.-6. tur.< cap. sm. ig iL DP "" '" total dose received from both external and ~ 2 ![essense. L.. k... A so li tt.auin U :s.: r oh r-K

interstitial radiation.

.nn.a n.i.n.....e..p,. i mnt,ntan.,n n ne ut ou t N.d b' k-W""""'- As we had hoped. the radiation exposure ton. I l L.H "' C *rr' "n's' h' l h "'.9d N.'i9 [~&In C "'" r . Ilutterwoii. H =.. pp has been reduced markediv hv the use of urs enxu t-K. au. r in.axi-n3: :m. r. k D "4 i "" l " "' h"""".u n'e".' t. t.".."u i. 9 d '"'D d"M"t ni uncer..t e ne '. iodine-125 seeds. This wa's demonstratedw".racotom y y f s p i durmg the months of d.eptember to De-sta. no bv. chan. xn!. in err - S "" M^"^' ..C '1 K~ "" ^* ".ma I ni r sc 6vit.rv

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From the AAPM Warkchop, Elcctron Linscr Acc31cr0 tore in Rcdiction Thercpy, Fcbruary 2-4, 19'11, Anch0im, Cclifornia ) HEALTH SYSTEMS AGENCits AND THE CERTIFICATE OF NEED PROCESS FOR RADIATION THERAPY ] tlilliam R. Hendec, Ph.D. Professor and Chairman, Department of Radiology University of Colorado Health Sciences Conter The Hational Health Planning and Resources Development Act of 1974 (P.L. 93-641) signed by President Ford on January 4,1975, authorized a $1 billien 3-year program of health planning and resource developnent under the llcalth Resources Administration of what is new known as the Department of Health and Human Servicus (HHS). The law added two new titlas to the Public Health Service Act. Title XV established a new program for health planning and resource development and Titic XVI revised existing programs for the construction and modernizattoi of health care facilitics under the former Hill-P,urton program. In 1966, the Comprehensive Health Planning (CHP) program broadened the planning concept of P.L. 93-641 to include health services and manoower development as well as facilities constrt.ction and emphasized the climination of unnecessary duplication in facilitics and equipment. The CHP program established state and areawide agencies to plan for and promote the rational and orderly development of health resources in their respective communities. As a result of P.L. 93-641 and the Comprehensive Health Planning program, the following activitics are among these initiated at the Federal level to accomplish the objectives of health planning and reduction of duplication in facilitics and equipment. 1) Issuance of guidelines by HHS on national health planning policy 2) Establishment of Motional Council on Health Planning and Development '3) Specification of procedures for designated Health Service Areas 4) Creation of network of 205 Health Systems Agencies (HSA's) to be responsible for health planning and development 5) Authorization of planning grants for liSA's 6) Authorization for HHS to enter into agreements with State Health Planning and Development Agencies designated by the Governor of each State 7) Creation of Statewide Health Coordinating Councils 8) Authorization of grants for State health planning and development 9) Authorization of grants to six States for demonstrating effectiveness of rate regula t ion IJ) Provision of technical assistance for HSA's and State Agencies

11) Establishment of National Health Planning Information Center

12) Authorization of at least five centers for study and development of health planning

13) Revision of existing Medical Facilities Construction Program

14) Provisien of assistance through grants, loans and loan guarantees for projects for:

-modernizing medical facilities -building new outpatient medical facilities -building new inpatient medical facilities in areas which have experienced 'recent rapid population growth -converting existing medical facilities for providing new health services

15) inclusion.of grant assistance to publicly owned health facilities for construction

.and modernizatien projects for eliminating or preventing safety hazards and comolying With licensure or accr2ditaticn standards !6) Authorization of grants to design'ated HSA's to create Area Health Services . Development Funds '17) Authorization of aporopriations for transition of existing planning and related programs to the new s/s tem established under the Act. M

The first step in implementing the new health planning law was the establishment of health service areas throughout the country. The law specified 7 months for the designation of health service areas with a deadline for publication of area designations of August 3, 1975 The Governors were asked to designate the arcas in conformance to several legislative speci fications:

1) The area must be a geograchic region appropriate for the effective planning and development of health services. determined on the basis of factors including population and the availability of resources to provide all necessary health services for rasidents of the area.

2) To the extent practicabic, the arca raust include at least one center for providing highly specialized health services. 3) Each area must have a population of at least 500,000 and not more than 3 million, with two exceptions. An aica may have less than 500,000 people if it comprises an entire State with a population of less than 500,000. The area may encompass more than 3 mill!cn population if it includes a standard metropolitan statistical arca (SMSA) with population greater than 3 million. The law also allows for an area to have less than 500,000 people in " unusual ci r-:umstances," and to be below 200,000 in population in " highly unusual circumstances," both as determined by the Secretary of HHS.

4) To the maximum exter.t feasible, arca boundaries must be appropriately coordinated with those of Professional Standards Revics Organi:arions, existing regional planning areas, and State planning and administrative areas, 5)

Economic or geographic barriers to the receipt of health services in non-retropolitan areas are to be taken into account in establishing boundaries. The basic elements in the nationwide health planning effort were to be the 205 Health Systems Agencies established under the program. In each health service area the Secretary of HHS af ter consulting with the Governor of the aopropriate State, designated either a private, non profit corporation or a public entity as the HSA responsible for health planning and development in that area. An HSA could not be or could not operate an educational institution and must meet minimum criteria speci fied in the law for i ts legal structure, staf f, governing body and functions. The HSA is generally responsible for preparing and implementing plans designed to improve the health of the residents of its health service arca; to increase the accessibility, acceptability, continuity and quality of health services in the area; to restrain increases in the cost of providing health services; and to prevent unnecessary duplication of heal th resources. The law required HSA's to: 1) Gather and analyze data. 2) Establish health systems plans (HSP's) - plans and statemants of goals and long-term objectives - and annual impicmentation plans (AIP's). 3) Provide technical and/or lini:ed financial assistance to organizations seeking to implement the plans. 4) Cocedinate activities with PSR0's and appropriate planning and regulatory entities. 5) Review and approve or disapprove applications for Federal funds for health programs within the health service areas. 6) Assist States in the review of capital expenditures proposed by health care facilities within their health service area. 7) Assist States in making findings on the need for new institutional health services proposed for the area. 8) Assist States in reviewing the anoropriateness of existing institutional health services of fered in the health service arca; and

9) Annually. recommend to States projects for modernizing, constructing and converting health facilities in the area.

The HSA must have a governing board of 10 to 30 members, the majority of whom must be consumers and the remainder providers. The governing body may be larger if it establishes an executive committee of not more than 25 which meets the consumer-provider requirements. Governing body members must be residents of the health service area and must include public elected officiais as well as other government representatives who ray be either consumers or providers. HSA's were designated by the Secretary upon censultation with State Governnes. for up to 24 cenths er permanently af ter They may have been cesignated conditionally the acency had been determined to be carrying out all the functions and responsibilitic assigncd by the Act. ~ Fully designated HSA's were eligible to roccive Federal Planning orants to support their activities under a speci fied formula providing uo to 50 cents per caor ta in A minimum of $175,000 the health services area, up to a maximum of $3,750,000. was required. The grcnts also provided an additional 25 cents per capita if this was rutched by non-Fedcral funds. These funds would not be contributed by any person or privato entity wi th financial, fiduciary, or other direct interest in the development, expansion or support of health resources. Nor would matching funds be paid for the performance of services. In fact, the contributar could not place any restrictions on the use of matching funds other than those imposed by the Federal Grants to agencies were subject to the annual appropriation of funds by the grant. Congress and the amounts listed above were contingent upon sufficient funds being The anount of the Federal grant would be scaled down proportionately appropriated. for conditionally designated HSA's, according to their state of development. Fully designated HSA's were eligible to receive Area Health Services Development funds *in the amount of $1 per capita for the health service area. These funds would be used by the HSA to make grants or contracts for health service development The funds projects which advance the goals enunciated in the Agency's NSP and AIP. would not be used for the actual delivery of health services. A State Health Planning and Development Agency was to be selected by the Governor of each State and designated by the Secretary of HHS. To be designated, the State Agency submitted to the Secretary an application for designation and an approved administrativ program for carrying out its functions. Designation of the agency would be on a conditional basis for up to 24 months or fully designated and renewable every 12 months The State Agency conducts the nealth planning activitics.of the State and implements those parts of the State health plan and the plans of the Health Systems Agencies within the State which relate to the Government of the State. The State Agency integrates the health plans of the Health Systems Agencies into a preliminary Stete health plan, to be submitted to a Statewide Health Coordinating Council for approval. It assists the Statewide Health Coordinating Council in the review of the State medical facilities plan required by the law and in the performance of its functions generally. It serves as the designated planning agency in those States which participate in Section 1122 of the Social Security Act and it administers a State certificate of need program satisfactory to HHS. Such programs provide for review of the need for new instituticnal health services proposed to be offered in the State. In addition the State Agency considers the appropriateness of existing institutional health services wi thin the State. The Statewide Coordinating Council is ccmposed of at least 16 menbors appointed by Sixty percent of :ts members are representatives of Health Systems the Governcr. Agencies and at least one half must be censuners. The Council preparcs the State

.~ .;y- -j health plan, reviews the budgets and applications for assistance o' Health Systems Agencies, 'and advises the State Agency on the performance of it functions. i t also reviews any State plan or application submitted to Hils for rcce.,)t of funds under allotments made to States for health programs. The law calls for annual grants to State Health Planning and Develocment Agencies to covcr.7s much as 75 percent of their operating costs and authorized $25 million for FY 1975, S30 million for FY 1976 and $35 million for FY 1977 if a State failed to participate in the pronram by 1979. then r One in the State was eligible to receive any form of assistance under the Public Hea cn Service Act. The lead-off section in, the health planning law directed the Secretary of HHS to issue guidelincs on national health planning policy, provided priorities for health planning goals and established a !!ational Council on Health Planning and Development. The 15-member Advisory Council is to consul t with the Secretary of HHS on the development of the national guidelines, the implementation of the new law and the escluation of implications of new medical technology for organizing, delivering and equitably distributing health care services. l'embership includes the Chief Medical Director of the Veterans Adninistration, the Assistant Secretary for !!ealth and Environment of the Department of Defensc, the Assistant Secretary for Health of IIHS, at least five providers of health services, at 1 cast three memoers of governing bodies of Health Systems Agencies, and at least three members of Statewide !!calth Coordinating Councils. The Council i s to be j divided equally between the two major political parties. 1 11 embers of the Council serve staggered terms of 6 years. Within 18 months of enactment of the law, the Secretary was to issue, by regulatien, guidelines including a statement of national health planning goals based on national health priorities speci fied in the legislation. In issuing the guidelines, the i Secretary was to consult with Health Systems Agencies, the State Health Planning I . and Development Agencies, the Statewide Heal th Coordinating Councils, the National Council on Health Planning and Development and associations and specialty societies i representing nedical and other health care providers. ~ The guidelines were to include standards concerning the appropriate supply, distribution and organization of health resources. Priority' consideration was to be given to 10 items specified in the law. These were: 1) Providing primary care services for medically underserved populations, especially j. in rural or economically d:oressed areas. 2); Developing multi-institutional systems for coordinating or consolidating-institutional health servicas. 3) Developing medical group practices, health maintenance organizations and other -organized systems for providing health care. i

4). Training and increasing utilization of physician assistants, especially nurse

' clinicians. 5) Developing multi-institutional arrangements for sharing support services. .6) Promoting activities to achieve imoroved quality in health services. -7) Stimulating the devcicpnent by health service institutiens of the capacity to i provide various levels' of care on a geographically integrated basis. l-v = s + r-n x-w y Nw >x-g 's r-w -yA-+

5 ..-5.- Promoting activitics for preventing disease, including studies of nutritional 8) and environmental factors affecting health and the provision of preventive health care services. Adopting uni form cost accounting and othe'r improved management procedures for 9) health service institutions.

10) Developing ef fective methods of educating the general public concerning croper personal health carc and af fective use of available health services.

In February, 1973, Joseph Cali fano, the Sacretary of HHS, issued a belated set of in the health planning health planning guidelines in response to the leadof f section I law (P.L. 93-641). In introducing these guidelines, Secretary Califano noted : "These guidelines recognize that, in large measure, in flat ion in health care costs too many hospital beds, is a result of the profligacy of the hospital industry -- proli feration of expensive equipment, and duplication of facilitics and equipment. Moreover, underused facilities and equipment can undermine quality of care and if physicians or nurses do not perform complex procedures often endanger life, enough to maintain a high level of proficiency. The guidelines published in revised form today seek to establish standa investment hospital capacity to specialized obstetrical units to CT scanners. When these standards were originally proposed last September, they generated thousands of comments and much controversy. And they should have -- for we are proposing meaningful standards that will result in changes in current wasteful practices. Significant improvements have We have listed carefully, and we have responded. resulted from the public dialog and from the extensive participation of scores of experts in the health care field. for example, made changes to address concerns expressed about the cotential We have, impact of the guidelines on rural and community hospitals, on obstetrical and pediatric units, and on the ability of States and localities to take account of special local needs. The revised guidelines propose these major standards: A maximum of four hospital beds per 1,000 pecple. An average annual occupancy rate of at least 80 percent for hospitals in a health service area. least a 75 percent average occupancy rate and at least 1,500 births annually Atfor hospitals that provide care for complicated obstetrical problems. No more than four neonatal intensive and intermediate care beds per 1,000 live birt A minimum of 10 beds for pediatric units in urban areas. Average annual occupancy rates ranging from 65 to 75 percent for pediatric units, based on their size. least 200 open heart pre:edures annually in any institution in which open At least 100 heart operations annually heart surgery is performed for adults, and at in any institution in which pediatric open heart surgery is performed. catheterizaticn 300 cardiac catheterizations annually in any adult At least 150 cardiac catheterizations annually in any pediatric unit, and at least catheterization unit. A service area with a scoulation of at least 150,300 persons or treat. rent of at least 300 cancer cases annually for mcgavoltage radiation therapy units. ' Health Resou.cos Meus. "ealth Resources Administration, Department of Health, Education and Ucifare, '!al. 5, No. 2, February, 1973.

At less: 2,500 procedures per year for each computed tomographic scanner. Plans censistent with already-established HEW standards and procedures for suppliers of end-stage renal disease services. These national standards are to be used by local and State agencies in preparing their plans. The plans, generally, should be made consistent ' lith the guidelines within one year. But, they may be adjusted to meet special circumstances and requircaents at the local or State levels. The guidelines have Lecn revised to make it absolutely clear that such adjustments arc in order. I believe these guidelines are tough enough to be effective, reasonable enough to be fair." Or. Califano continued later in his comments. "The success or failure of that process \\ will depend in large measurc'on public support for strong action by local officiais. Two related processes are established under the Act: first, the oreparation of health plans for localitics and for States; and, second, the actual decision-making process to aporove or disapprove proposed capital expenditurcs. Decision-making authority in both processes rests entirely at the State and local level. l The basic elements of the structure are 105 Health Systems Agencies, each governed by a board of local residents, the majority of whom must be consumers. These local j agencies are responsible for preparing health care plans for their areas that identify t and set out local needs for medical facilities and equipment. Under the statute, these local plans must consider HEW's guidelines and the local plans must be " consistent with" the guidelines. These local plans are incorporated in statewide plans - which take account of special regional or statewide needs - by State agencies called State Health Planning and Development Agencies. The State plans must be approved by Statewide Health Coordinating Councils, which are appointed by the Governors, and which - like the local health systems agencies - must be broadly representative. HEW's role, therefore, is not to make decisions. It is to establish broad national standards to provide general guidance to the State and local agencies. Those agencies In turn must take HEU's standards and adapt them to special local needs and conditions. Dr. Califano concluded by stating, "This first set of guidelines. will be a long-i overdue milestone in implementation of the historic National Health Planning Act. Despite the Act's mandate that HEW issue. final guidelines by mid-1976, the previcus Administration had not even published proposed guidelines by January,1977

But, this Administration is conmitted to making the Act work.

The Department will soon propose additional guidelines to establish national health-planning goals and to improve the nation's health status, provide better access to health care and promote preventive services." In part, the guidelinas issued by the Secretary of HHS require that each state establish criteria and standards for review of the appropriateness of existing institutional health services. A -general f rancwork for these criteria and r standards as they certain to a specific institutional service is provided by the Federal guidelines. Incividual states, however, are encouraged to deviate from the Federal guidelines ahenever deuued appropriate by the State's Appropriateness Review Committee for the speci fic service. Selected Federal guidelines which are relevant to radiation thcrapy facilitics are listed below:

7:- - Standards: A megavoltage radiation therapy unit should serve a copulation of at least ISO,000. persons and treat at least 300 cases per year, within 3 years of initiation. j No new units unicss existing unit is performing at least 6,000' treatments per year. Pu rr,ose,: ' ltcgavol tage equipmen t is expensive to purchase, install, and support en a i continuing basis; therefore every effort should be made to avoid unnecessary duplication. ' Standard-soccific Ad]ustments: Travel time - Adjustments may be justi fied when travel time to an alternate unit is a serious hardship due to geographic remoteness. Definitional Considerations: A " unit" is defined as a single megavoltage machine i or energy source. " Treatments" are meant to be the same as patient visi ts. A treatment averages 2.2 ficids. Special Considerations: Half of new cancer,atients require radiation therapy and many requi re subsequent treatment. Dedicated special purpose and extra high energy machines which have limited but important applications, should not perform 6,000 treatments per year due to possible limited capability, and should be evaluated individually by HSA's, t [ ln the State of Maryland, a Task Force on Radiation Therapy Services has developed 1 (published August, 1930) criteria and standards for megavoltage radiation therapy units.2 These criteria and standards are described in the next few pages and provide an excellent guide to the types and depth of data needed in an application-for a .i Certificate of Need for a megavoltage therapy unit. Scoce of program: Results of aopropriateness reviews, including recommendation.for 3 i remedial action in cases of inappropriateness, will be published in accordance with Federal and Maryland regulat*ons. Such regulations will include provisions for review process 'and procedure, and will provide for responsible use and publication of data and findings. Focus of these criteria and standards: Criteria and standards address the following: accessibility availability-quality cost. Acolication: The primary program'in which these. criteria and standards will be applied ?

is in the review of cxisting institutional health services.

However, to the extent

applicable, these criteria and standards will be incorporated in Health Systems Plans and the State Health Plan.

Findings based on these criteria and. standards are required by statute to be~ considered during Certificate of !!ced reviews. in' all cases. the standards as established are merely indicators of the need for intens review. Determinations of inapproariateness will be made after reviewing additional-information supplied by the service under intensive review. Task Force on Radiation'Theracy Services, Maryland Health Planning and Development 2 Agency,1 Department of flealth and'Hental Hygiene, Criteria of Standards Applicable for 19o0'. ' Review of;the Appropriateness of Existing Institutional Health Services, August, ~ 4 ~- ,3

n x.- _ -.. ~ -.._w-8-

== HSA adlustments in standards: In some instances, the numerical level of acceptaoitity may vary from region to region in response to local conditions. In such cases, HSA's have the option to adopt local variations in standards. Actual figure will be established by HSA's electing to do so. Such adjustments must be acceptabic to the Statewide Health Coordinating Council (SHCC). Revisions and undates: Radiation therapy is a field of medical technology subject to a great ceal of improvement as time goes on. Criteria and standards will be r revicwed and revised or updated on the basis of program and institutional ex-t i pcrience, new kncwledge, and current medical practice and experience. Relationshio to other service-soecific criteria and standards: These criteria Ond standards are one set among stveral having been or being developed by the Maryland Health Planning and Development Agency. Criteria and standards for other services may be obtained upon request to the Agency. Process of develooment: The criteria and standards were developed with the advice of an expert panel assembled by the Maryland Health Planning and Development Agency. Members were nominated by HSA's and by af fected statewide organizations and interest j groups. Relationship to National Guidelines for Health Planning: Because of this development l process, these criterie and standards dif fer in some respects f rom the National Guidelines for Health Planning. Focus of review: The major focus of review is megavoltage units, since these entall the greatest resource outlay and therapeutic input. Other services such as orthovoltage, superficial voltage, and local irradiation wil.1 be recognized as having a place in a versatile program. i L I. i 1 [ i I l l ---,v.

J =, Discussion & Special Considerations ?riterion Standard Purpose & Applicabili ty SCCESSIBILITY Paticnt travel time One-way travel time for To assure patient comfort and Travel time may be greater in cancer patients to radiation safety and to avoid undue remote areas, depending upon therapy treatnent is not to proliferation of facilities and terrain and other uncontrollable exceed 45 minutes dilution of expertise local factors, as determined by H A's ' Institution-specific standard Provision of adequate parking for Patient parking No enforceable standard radiation therapy facilities at or is established at this time near the place of treatment is . f aci l i t_i es desirable Access to affordable lodging for ' Patient lodging No enforceable standard radiation therapy patients is is established at this time desirable for those patients who do not live near radiation therapy facilities and have an extended course of treatment llours of operation Ho enforceable standard Extended hours of operation of is established at this time radiation therapy facilitics is desirable, to facilitate treatment of working patients, thereby enabling them to keep their jobs All referred patients are To assure that the poor The Task Force members believe to be provided with needed are not denied access this and the follouing standard Financial access RT consultations, within through inahility to pay to be 'ully met in !!aryland at hjstinie. They reconinend that heir cap W iity to pay institution-specific standard third party reimbursement for consultations and treatments be available, to assure appropriate diagnosis and treatment of cancer patients No patient needing treatment To assure that the poor are is to be denied treatment be-not denied access through in-cause of inability to pay ability to pay Insti tution-speci fic standard /hf

) n e ,e t sd n ym yt o o i rrd nt s t nio t e c h d hri ooe ey ol i i ag - s hbl iAt e coc tf v csr i i rt - eti o os i l e r aji aro t i tS e al ot al m niamat d er t usnh acl rl e r, d h at ns p iu mn npp soioti : ono c i t e ui ye q,e a a pf ocgc d pcof sc asni mA s Hd cnh sed go neaonee at irnaws b grr ymr ot na n o esa o t rdit f at ti t mea ru r aer i i yg srl l d o y a gi sramaol t vg. C onsa sf ead cb n eeyoesr npred aoni al eos cu r a nb rvh na a gl h ni n ,l m tb e i maat od t rol e u ii n a i s e p e la rsn a pos i n uer oh nt pmard nl r oeime siu h uM g i e e. ob ya c f n ir t cn ert a bh pct a i i i gcacnn cap e nisra f an a nmout t l e l ae e orer meI f t s e r n e p n ;. i p ol i it sgahi rt i near S ce tl k e h o i l dt nl nna f t w ,t s b occet nd ay caeo a oot a o .t hsi ainih noi( h ad uvh m diI ii rl oy cnh rt ar ;eit p nsat e i r u m l s ,a r ace mt n aG ns t t e rt pf rit i e aadl e aoa si m ,t cungt oen ,t b on i nl g el nl ne b nr egy ed aAsanmons o d i ii n ii s aannt b iuun moemsnb d a neu s t ni aa mp uih uei r neorf ot rposdt u son ul r oea nt t mrhd s ihet t a r a e s. l ad ce itht g a t er geuie c ind qi e pb i i s et aeea t - p ed rxrat at rd dl f er cod t t hi yunonueh uch aa h al sd v eoox hd oeoea I t wbS at asrt sAsrc i D TNP uaa D t t e Taf nf t p s f t l y oi i t n a eru v i e an l l bb y o i b amp d ei d a nua r t t d r c onr a aas r a i s e d uie a d aeh n qd c d n lp eht a eai n a p rt t d rv a t A e s a r t s ang f e s oa e eos e e t d r l d uyy a i e cgl i s ano w st p n w v e si a o e o l i p pl a t al r i t e g a g a i r i u oee t obh e t P T cms T at R S g s i n e - i t y ahl d m e sp gca ri r aa eac at oe er mei d e td ns mg l a n h e e ai ot - o t t nl n s t h nl ri a oa e st oet e nrs evpa eg eooo et a b a l b a bif p l gt u t g r b oeip ol oenu ad t mno t o n t rop ee ch up v o i d se sari s rth rs euc oi get n y0 i i r i a o p0 epa pt r f l i a nb d e a 0, em e l n rnr r t u rt t e ea a eae0 eeip eiss t t hhh5 h nn h nne os S Tt t 1 T oup T uir N e 'e ep g s go a e t c N ap r l l O t o oa u I l T ot vc o A v ai s R as gd e T gt ee r N ei mm g C mn f r n n C u o N f ooh i f c Y t O oyn ir C po r r T l z_, e oai esa I u rt b t e L s t T i i f t ea mis A n r n ahl une U o C U R t u H ur Q C L

~ 1 1 " Criterion Standard Purposa & Applicability Discusson&SpecialCon2idefations consultations will facilitate the determination of the therapy'of choice and the appropriate com-binat on of radiation, surgery, i and/or chenotherapy. Accreditation of RT llospital owned and To assure ongoing quality ' facilities operated RT facilities review of RT facilities by are to share in periodic qualified outside authorities JCAll accreditation of the and professional bodies In spi I p ovide ! that institution-specific standard act participate in the JCAll survey, the facility needs not comply with the standard Institution-specific standard Therap.ist certification Radiation therapists supervising radiation therapy f aci li t le's are - to be board-certified in radiation therapy or radiology Facility safety Radiation therapy Institution-specific standard liaryland radiation safety standar< and licensing and registration facilities are to meet provisions are compatible with radiation safety, Federal requirements licensing, and regis-tration requirements of State authorities under Collar 10.14.02 llegavol tage machine institution-specific standard !!aryland megavol tage machine accuracy and safety standards are accuracy and safety compatible wi th Federal requi reme: are to conform to This standard is still applicable-State safet y standards should C0ttAR 10.24.03 he incor-uniler C0t1AR 10.14.03 porated into 00ftAR 10.24.02 - +

s s n i f se o no mi e i n t b a rv da oe t a o roi c r ct t y mn oh a f R t t n . - pp a i t ot d syua s i t rrrfb d w e cs s noreoa e s o n et eh t s dC o mat t td ce s o i s C ed n nen ei e gninet a pt n r e ece l na ovci xi i pi c a amfi eec el l i e vn i r ot pi c rt aexs sc d nra oew a i i e aoeih ey f u0 iS o p ncdt nh S p na up e G0 t l ut arn gy 0 ahl 6 i t a - ud ir g nb l kbif on a a ci rc. nf ean n c oos i i r oo r co o aev t nh pi s b seoa eat t m e f i i bl aenwc rb o i s s l aer md e pna au d es u arr ut k t pil N m hi st m c miuoaa uau i m s rssceee t m en i i oes rrh nti hi h oo D Fd aatbt A as T m T tC ey f y st ol y d ui d d d d e t t r - cd r r r r i a ran a a a a ven l d epa d d d d ose n r u yi n va y n n n n uqpc a ocyp a a a a y ooeaa t t a t t t t t h csrf s d eir s s s s w b e nnl e i l euh r c aiah c c c c h ut i i i i i sh st e i b t t h f ecq f f f f i i i i sa d a n ynt i c egaoo c uah e c c c c inmin e s t r e e e e i l ti t a p reoe p p p p p arra s e gb v s s s s p puoin - d a.i - n nt gl n n n n ,di A d a o ul ne o o o o t oid i i i i cet rt i ecn n t d vr t t t t e t neoe u iaef u u u u s oemgm t o gd o t t t t vei i 'i i i o rdt rt i p pi aea t an st t t t t r sed e s ns s s s s n n n n u oernr n of oo I I i I T occ P Trt ut I s e n e g e d i g a ye ye d t t ad s-t pw pt rs n n re t rl at aa ai ene et e neo r e rid em vag epv ebk eco dh i nt t t t aea m a h e h ei a at a rt t eg t d e t r r t t pi e ntl ab e ew pe sa rr a o e m es eep gwt sv r o gur gd ed n et a t t h a e a r l e iaT b ng c t ep t ea l b e b bh t R eet eat l as sn oimi r ei o s o y ei eef t t n a n vor vo-cl uvo aru yu at u at 0 d rb qi spe t yb g o g 1 py sl y esh es r oa egy i a f t r r p al d p mi ni a d ns ea e ya eaea 5 un r ht 5 h t r n eee hb m r l r l a m c m e ie nr e ci-cie 'osi aou hf ah t noh an0 anv t S Nit E t s T odt Aaf t E u4 E uo rep s s t tn ne y e m r mt e e a ti m g~ m an i n m eu t a' u r e t e l f r s g a i r n a t f a n l o n ot o e l i p' e ir u m ro t n t ev a i e t k a T b a r h ,~ c e S mg e c ir a r O ue p a 1 C B' T C N m O 1

,.) Criterion Standard Purpssa & Availability Discussion & Specici Conside'rctior; The obsolescence threshold To provide an orderly and for each megavoltage economical match to the pace therapy unit is to be of medical technology between 5 and to years Institution-specific standard ' Unit a' Each RT facility is-to, be Institution-speci fic standard prepared. to justi fy deviation of RT unit cost greater than 50 percent of the average unit costs reported by all RT facilities to the llealth Services Cost Review Commission in the preceding year if sharing arrangements exist, . Sharing arrangements No enforceable standard is they should be subject to annual established at this time re-examination by each RT facility involved Capitol costs Proposed new facilities and Institution-specific standard Capitol costs vary by type'oIf RT facility. At 1979 costs, the facilities proposing capital range is from $750,000 start-up-expansion are to demonstrate capital costs for a private financial capability to practice group to $1.5 million foi handle start-up and a regional center operational costs + e-m- .ae. y

14 - DETERMINING REGIONAL NCED FOR MEGAVOLTAGE THERAPY UNITS The formula adopted by the Task Force is described here. Occause of age-HM0 and Federal radiation speci fic population dif ferences, differences in patient flow, ' therapy capacity, and the needs of populations in remote areas, agencies should adjust the formula according to the specific characteristics of their own areas. Assumntions incidence of cancer is 3 new cases por the current 1) National data indicate thatNo Maryland-specific data which could be substituted 1000 population ocr year. for the national data was available. Members' estimates of the number of cancer cases requiring radiation therapy rangch 2) A consensus was reached on 65. percent, but subsequently from 50 to 70 percent. it was agreed that better data was needed before this figure could be used with confidence in the formula. 3) Members agreed that national estimates of 20% of new cases require subsequent retreatment were usabic for Maryland. Members agreed that a local-arca average of treatments per case should be used 4) for computation, with annual review of services to make adjustments bssed on current treatment protocols.of all case treatments are by megavoltage therapy. Members agreed that 92.4 5) Members agreed that a local-area average of treatments annually per megavoltage 6) unit should be used for computation. Members agreed that 20-30 treatments per day was the desired range for output, 7) with the upper portion of the range attainable by facilitics wi th a simulator. Formula A two-stage formula is used. To obtain the number of cases requiring megavoltage radiation, the following is calculated: 1) Population, multiolied by Cancer incidence rate, multiplied by 2) Percentage of cases requiring radiation therapy, multiplied by 3) 4) Percentage of cases requiring negavoltage therapy, multiplied by

5) Adjustment for recurring cases.

Stated mathematically, the first stage is: C=P x I x % x3 x A. To obtain the nueber of megavoltage machines required, the following is calculated: 1) Number of cases requiring megavoltage radiation (from the above computation), added to 2) Het migration; the sum then multiplied by then divided by 3) Number of megavoltage treatrents per case; the creduct 4) Treatments per megavoltage machine per year. Stated mathematically, the second stage is: N= (C - M) xT y Tm For each of the variables, the following steps are to be followed: The appropriate year's population estimate or orojecticn must be A) Population. selected. In the absence of small-area data, the national incidence B) Cancer incicence rate. Agencies with small-area data cay be able to of 3 per 1000 should be used. distribution substitute an incidence rate based more directly both on population (there is a greater incidence in older populations) and on area-by age group specific incidence of cartain Linds of cancer.

15 - C) Percentage of cases requiring radiation therapy. Agencies should develop their i own figures within the 50-70% range establisned by the Task Force. [ D) Percent of cases requiring negavoltage therapy. Agencies should use the 92.4% figt i E) Adj us tment for recurring cases. _ Agencies should use the 20% figure agreed upon by the Tdsk Force; i.e. a multiplier of 1.2. Agencies may wish to examine the degree to which this figure reflects practice in the area before using the [ adjustment. j F) tiet migration. Obtained by subtracting area residents who are handled out of the [ L health service area from non-area residents who are treated by facilities wi thin the area. j G) Number of megavoltage treatments per case. Agencies should use a figure based l on an average of local-area radiation therapy #acility experience. i H) Treatments per megavoltage machine per year. Agencies should use the 6000 finure i set forth in the National Guidelines unless another figure is determined to more I closely reflect actual utilization. I l I i 'b I P p r f

e t l u on r af e bb l e b ot sy n d 2 rl d t ee n' b al nait c caahl a a at g t n l oaf yd usn ncorl q o s au em nos df nMoeh a in eoo ,ht t sa l t o e i na nmt s i ii r ar yrir nt a rorel ph r i f r ef etl ot e ee t pnarif Dd nyoerpwe erocep r i ,s cec nae sn v~ T e ry enR geab t o l nC a o h c e nt pl st f t ml oauat e nnt or t a i si grd oee a uc et eiige je r sgt pe d p o a e a o yh AS At b rpt t t S E I f s T oe I y i L r kt d I C r aari ol i A a t nwi F dn rit c Y a eh ea t t nf P t i A S R aweTvR E f H o eti r ntl T e ueaa snrn a s v o soeo t i p a p pi n, T r mog ee A u oooe mg P T ccr pn I )i a D sur AR d t q n t l ee d d a n o d F O e e y v yi n t n dh ms pops) a c pd al at c y-l C e pa a d sa o S l e rirui ur i v ar t se ti i it rt.o t z nc t r oa ue ek eob I t nenyt ni eo a e h e on h h a T el is t h ss c t 0t st S t e8 eip aehit l l t e ;r rmt i0 y a:ia t s I e ut edl 0l mrti aa u o sro T n l 1 l R r oac p sg r a R e e-et c E cal n i 0, l of pes m nnn eTr m t5ti c T eeab f rt a1 u f pe f o oii t R g f t 8 oa a C d v l p n sf si or cd n o oa l ( A aarn et o t f ns eer e a eas ot R e e yi cea vn si t s gens cvp er:it t gi A gt gcnae gvtt v ael sl ndl nt al I H l t g n nieemV i ti a n iii y o s h maei eea C l r atl t r t erl c mrt d act acn atif ms f d raisasn d gr a t ri i ii nai red rp- 0 nemf aep vh sp o h e u e i p '; 0 a ml pue 2 ib rt t e l ec l aeiai uaf o ef s ot ys i d cuqc2 - l l pt vet orerT r eo rih o gva l 's l n uaanar a h r rfR t rh p w ph eae uonsed( 6 a S F pcicT p S a-Rht F t i - t y t yp o i t a l r r d i c e e p n i a t h a h s t F n t s e gi n i e nTi T c f nc e n R o ort ir m i i h a p o t rl l f a e c e i r o n p aei i. as u l h c e-o o ee q et a c T r E t. e i R of p g S ir y e C T R M

L a4 Adjustments, Definitions, and Criterion Standard Purpose of Standard Special Considerations Staffing Center. should be under supervision of a full-time, board-certified radiation therapist One fulI-time radiation therapist or radiologist with RT training for every 150-200 new patients per year One fulI-t ime rc:diation physicist, certified or cligible for certification by the American Board of Radiology or equivalent, for every 400-600 new cancer patients per year One certi fied or equivalent RT technologist per 15-25 patients under daily treatment or one or two RT technologists for every piece of MV equipnent One fulI-time treatment planning technician for every 400-600 new patient pe r yea r Support services Should have computerized treat-ment planning support, an active tumor board,-and multidiscipiinary consults. CT scanner support is desirable but not mandatory y -,..r-,, y. v.- -. ,y,-. ---,m,

y ygd p l ne a nie "dd-r d ot n t e e s serh . d ~. tdi e il at n aexh pf o a rh et aiBh es rt t pi nd er ai s ol ae h e w n b t t cr os d ah a - ot n nt t r nd s i .t o asit orti ews asg i i i nt d n t oio i a eeno aB pl f r nb om ao i ee w e d ari i Dd ontd a ed i aa rrh a cis et r ,s - l s n a ca dh t o t soh et ndoeg nC ies ii e pl sy f eiin ml st at tfi i t a oI sain i l si h1 rl anit i uc iei uad ra je wct c Qeaer d p eaf a " mrct AS Nf af h o t et ie h T ws () c R d 2fi e y2 ohyn t t wew aied h o i l gl yt y d ciaot rt r o c ph i eii sa sl r el d sf neaohi n a or uf tb T hqe a a t sRdt b ep S l r d .ra agaanti c f t nd aeu nh mqt o iI pt asd cn e ssti aeae s oiSl ob m o h x bl dt r p et aktl a T e r r st r sue R n u onasouor e n P f al ewmct h , al t tl a spn o r,i s eepti t d mang sn y y niree e p p ut emr l ev s am a) a - ht t t e d rvr eI t ar g n eK e) bl eo i t t n y i aae st pn a h hV unrf) l i l tl d ssa t 0t M df ot e sv I st a: nal nt or gs e8 e l i 0 uatd ao l t a mreia anh r nm l 1 l a e-e2 o an b aap r oicn e a i f pe of t eo nim hr t5t - hfi asa sod d o rO f a pi ot ot cg 8 4 1 dtO spsg arl ao l( d( at re en i et e gpf u er a e enr sae l i t t t co id s ga,- vnggr) n s t p n t0' aenn sigd n

cnan iid gn(

d aen0r h miio( t neo eh ti eee vseoa r rve3a errt rl i r c vc sf msm riil t s a im e d gri eut r ar ar p-p evf osr neuet saeh h a c e i pi sri n e d d t t t y l a orear oreeaeorei ys a g el h et pueu n aaas uaf qr nnef t e I t rur ee hr rrccct r w ae t i eq epacmn S B ctl p S a-Mr A -. ed e h uueae T sqt sc n i d s 'y nsa p o aee a t cr r di a e p dn i ev h nrn t h s a s e t wea. ost f nTi gh n g n 'o ort nc e n i. i r m i i i l dl o r t t p p aei ce f aeo e t rl h a p f i i l h c as u a ao o e i t prr c et a ee q t set S R of T r E S 2 ir ope C H on 5'

~ C iterion Standard Purpose of Standard Adjustments, Definitions, and-Special Considerations } Support services Should have computerized or manual treatnent planning support, active tunor board . and multidisciplinary consults. ' CT scanner is desirable but not. mandatory llospital owned and operated services in remote areas Scope of Therapy Broad range of curative and To assure remote areas are For this purpose, a remote area palliative treatment; 300-500 served by diagnostic and treat-is defined as any of the State new patients a year is a ment services of an acceptable where cancer patients live more desirable but not mandatory quality than 45 minutes one-way travel tim. from the next nearest source of utilization level in a remote RT treatnent. A remote area RT area as determined by the llSA. As low as 150-250 new patients facility may serve too small a population to maintain the annual per year is acceptable 300-500 patient load level. Relationship Regularly scheduled consultation to other visits of a therapy consultant RT facilities plus telephone consultation with a regional center Equipment - At least i unit each of 11V and superficial RT. Simulator and computer support is desirable hut can be substituted by manual isodose planning and set-up on .the therapeutic unit itself Staffing Supervision by a board-cert i fied radialion therapist or a board-certified radiologist with therapy training. Full-time radiation physicist or availability on a regular consul ting basis. Full t ime radiotherapy technologist. a

~~ ' Criterion Standard Purpose of Standard Adjustments, Definitions, and Special Considerations Support' services Ancillary services may be availabic on a' shared basis (diagnostic support, transport,' reception, . secretarial, etc.) Tumor board consultation and 'tunor clinic is desirable but not mandatory. Private practice g roup Scope of' therapy Broad range of curative To establish a threshold of A private practice RT facility and palliative treatment, workloa,d and quality which is a proprietary RT clinic. A sub",tantial volume of radiation Treats at least 300-400 should be met. therapy in the Baltimore Metro-patients per. year. politan area is performed by privatt practice clinics,-related to Haryland hospitals by referral and consultation arrangements. The criteria and standards for such clinics have been developed in consultation with the private i practice physician representative, reflecting physician concern for maintaining standards of quality, service, and cost in full consonance-with general State RT standards. The standards and cri teria are voluntary, hoaever, and do not carry the force of law for such private physician facilities. Helther do they imply that such facilities will be subject to Appropriateness Review under exist-ing planning legislation.

Adjustments, Definitions, and Purp:se of Standard Special Considerations Stendard Criterion ~ Relationship to Should have formal other RT arrangenents for: facilities -referring patients requiring specialty care to regional center (s) -consulting on and treating RT patients referred from hospitals with consult arrangements Equipment At least: -superficial teletherapy equipment (85-180 KV) -deep-seated teletherapy equipment (4-20 ftV) Should be under supervision Staffing of.a full-time, quali fied radiatiai therapist. Full-time radiation technologist, and a quali fied radiation physicist available on a regular consulting basis Support services Computerized or manual treatment planning. Multidisciplinary consults availabic t hrough arrangements with hospitals or other. physicians v ~ m

~ Purpose of Standard Adjustments, D:finitions, an Criterion Standard Special Considerations RT arran'genents in l:mspi tals wi thout RT The purpose of consultation hospitals without-equipment and staff' or association arrangements is to assure the availability of RT RT equipment should have either a specialists for early diagnosis consultative or of cancer patients in hospitals associative arrangements without RT equipment and. staff with an RT facility Consultation may be made by phone Consultation Arrangements for or on site. Ubere warranted by the arrangements, consultation consult, patient referral would providing phone (regional centers, follow and ad-hoc hospital owned and consults on-site operated facilities or private practice groups) Radiation therapy Association Arrangements for association treatment would occur at the (regional centers, hospital associated RT facility arrangements, pro-viding periodic owned and operated facilities, on-site avail-or private practice groups) ability of an RT physician and re-ceptionist 4 u 9

( l i l c l 1 1 l I i. A Proposal for Integrated Cancer Management i in the United States-P i l i THE ROLE OF RADIATION ONCOLOGY I r i 1 i Report to the National Cancer Institute, NationalInstitutes of Health by the l Subcommittee for Revision of the " Blue Book" (1968 Report) of the 1 Committee for Radiation Therapy Studies t 4 A8 November 1,1972

I SUBCOMMITTEE FOR REVISION OF THE "8LUE BOOK'* TABLE OF CONTENTS (1968 HEPORT) Dr. Samuel llellman. Chan man iii Dr. Robert Parke Iciter fium tir. Simon Kramer, November l')/2 Dr. Max Boone i einer lium Dr.1. Palmes Saundeis, Januaiy l'773 av i v COMMITTEE FOR R ADI ATION THERAPY STUDIES leones isom Dr. I uthen W. litady, Apsil 1973

1. Inuiafucunn I

Simon Kramer, M.D., Chairman William E. Powers, M.D., Vice Chairman i Luther W. Brady, M.D., Secretary

11. G..ais in Cances Management ill. Itadiation Oncology in alie Tieatment ol Caisces..

2 Malcolm A. Bagshaw, M.D. William T. Moss. M.D. Fernando G. t$lo edos o, M.D. flober i G. Par ker, M.D. IV. Implementa hm of Goals.. 3 Max L. M. Boone, M.D. Phibp Rubin, M.D. Samuel llellman. M.D. Jerome M. Vaeth, M.D. 5 Fsank H. Hendisckson. M.D. T. A. Watson, M.D. V. Specifie itecoimnendations for Itadiation Oncology VI. Ca.nclusions. 33 Vll. Appenths I 34 t I l 0

Delaartment of Health, Education, and Welfar2 JilOMAS JEFFEHSON UNIVERSITY Public Healite Service Department of Radiation Ther.apy National Instit:les of He.sith w. eral Nuclear Medicine Bethesda,Marytand 20014 November I,19U y,,,,,y g g g, f 3 I u nt L Ha.estws,11 16 iliue tos Nae: anal Canier institute iscthesd.s,11.as)1.uid 2titliJ g g. . gg Proteuos and Chairman I lur Dr. Rausstws; g ,,,,,g gg ,, g g py aint Natte.ar nicJachie lies hfferson Unhessity llosput t he OklS lus 1.mg cauleavored to deline the ptse of r.nlutkm on... logy in sclanon. u slw autil tances pr..gsam. Its 196N repost "A Psospect (or R.sdulum linblelphu, PA 19hD thesaphy un the Ismted Stato" ollesed proposals fos the liest utduaikm of s.adi.ition ~ heut hy posult at t:us time. g g, p,, g,gg e pusmy s'ae past tour )eass thcse h.is been inescased awareness on the part of the 1 want to eluuL yun usa twtulf ut lit. l'sanL kauscher, Inucctor os alw Naisonal sescas her. ps.astating physsaan and the public ahLe of slic magnitude of the cancca i psoblem and ut the usycut swsenety to use anultidiu spihusy appriushes to conques it. l Cances inu uite,f.n ik ewellent repusa use she status of s.edutsoas uno.loy) pscpascJ by t he sole of radutsuo thesapy in Blic turassyc and palleative siunagement of cances the Counninee sur Radulion 'llwsary Studies 'lhe Dnishm of C.smyr Crants of etw runsmues to e spand. A hetles understanding of its saJio biological basis is bcing gained; ga,;,nul Camer lastnote is luppy to lure priniilcJ thuncul suppos a los the prepasation smht.itions and presissina tsratment techniques see being sefined;new types of sadiations (J ihn repun. b.commg a seahty, alw use of udiation eherapy m combination with surgery, Ihis repost curretely idenisaws some of the clunyes ilus h.sve taken place ha she aat ilaemothenary, and hopelisily humunothenary is being cxplosed. The potential of our puctice of radiation therapy since the original report pupase i by thn Cannmitiec at alw spessahty is f ar (soni != sag fully reatual. request of tle Regasuul kleshcal Prograus. Imph awntauun et the sconimwnJatiims an We theset.uc twhese et tuncly to present our russent thinking and to submit l suorunemlanuns for the uptunum utilization of radiation oncology in integrated canaa the nem icpuss would go a long way he snyer.nsug alw quahty u(care pauisded so cances patientn and woubt contrib;ste appreo.shly to alie impicnwntainen of the Natkiinal Cering matarcanent. in ihn acpuit we ase uung the terna "sadiatism secology" to indicate that those

11an,

. stanwd in uur spectahty must have a deep un terstanding and a comrmtment to.sil l twgiese that ains repuit stiuuld luve wide Jnstehunosi and laope slut it udl be aspass of imsology. Rath.stson therapy is she tahnkgue by which our Luowledge is brought to the auention ol' tisose inJaviduals in the heahh psufesoons who caen brinr alg.hed to the canter patient's benefit. Cessaan sonapis ase lushlamesital to our peuposats: These must be ame optunal atuut tis clicctive implemesitatu si. 't he Nauunal Canas in>iitute is scady so prosule Icsci ut case fos all s.inas patients, regaidless of how and where they enter the health tunds and supp ut fus slaas Jntrate sm as you datde case syuem. Mode:n rancer siunagesnent requises an integrated appsoash ley nuny Jitirient specialnts ca(h with his own expcstine. 'llw sigmticant impsovements in sesults g 3;,g,cgy you,,, ut eaincJ in the icw cenices of estrlknee mans esow twtume.sv.sd.able to all panents. And, i most my=nt.antly at amnt I e geougnised slut the instui nunagement alecision is stic most unkal sumpunent in the are.atment of a canar patient. 'therefose, the experthe of the san 6er susgeon, r4Junon uncohigns, the snedical am olugna ami the pathuh> gist tuust be e aradable wtwee and wtwn that suanagement daision is made. l L Palma s Lumh m Ph R I)ur sepunt offers speath recomrierulations los sadiation oncology in the Um. sed n,. i Series. 'llwis implementauon will asnetove the patient sesyke in uw fickt through a Dnnum dCan.cs Gsants tiroades tuse ul sonsultatum and'the t:fticient and econoenical use of sophisticated g g,,,,,g p,,wc,g,,g,,,, Icthniqces and c+aipment. Resea ch and trainmg wdl be a>ndusted a,n the mvicu Iscas suited to thcut. I nt, raps.dly imlessant will 15 the ' imp.act ort all aseas of carwer,, 9 't he' custenw.2f a sompasatively snuti cohesive group of rad:stion e maragenwnt. uncologists wuskir(, ;-nutty in a numt,es us'institutisms wdl focus attention on the value of unspesative effort liais group c.au 6eow be pivot.alin sateracting with a larges m mber l ut suaycons. intennists am! uthes playsicians, truly to bnng about an inte:Jixtptmary.. I opsmul approasla to canter case. 2' Resprs atully unbmitied, I Simon Kramet, M.11 Guhman, Onnmittee for I R.sJunion t hesaps Studies SK:Ls n ine

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I I. INTRODUCTION Optimal case must he uniftundy available.no all patienis with cancer regaidless of geographie conseraints, enanpower ti.hisatiims,econinuie s tions. 'and vaiiations in meihuds of healde case delivery. hlodern cancer management requises the integrated acuvity of a lange number of disease health psofessionals, each with special ' competence. This activity sequises sophisticated and often expensive facilities. In the past, these needs h well4eveloped, highly specialized centers' of excellence which have tocontributed significant improvements in cancer management for limited segments of the population. It is essential that this demonstrated excellenc become an integral part of cances care for the entire populationi. 1he initial manageinent decision is the most critical component in the often made in the care of panents with cancer. This decision is most physiciani of6ee, the general medical clinie, the community hospital, other sites of piimary medical case. The intene of this sepost is to desesihe a method for achieving the integration of speciaheed cancer man.sgesnent within the over all system of heahh case by the formation of Conjoint Radiation Oncology Centers utilizing much of the aliesdy available health resources. The seport will specifically desenbe the sole of sadi.ation twieology in cancer case. Similas organizational stiuctuie will be needed for the other cancer related disciplines, and is is expected that this program for sadiation oncology will fa,ilitate such planning. II. GOALS IN CANCER MAN AGEMENT

l. The cancer patient shou!J be given the most tarorable management to as hies e cure or long tenn control and palliathn of the Jisease.

1. the snganizathmal sinocture Jhr cancer management should provide for onIr the optimal terciof c.uc.

should be acaitalde to all lutients

3. This optional management ocyarJicss of econornie, social, or geographsc considerations.

4. Multidisciplinary parthipation in prevention,.tiagnosis, treatment, be available in any.cirannstance in uhich cancer and follourup must managernent is satJertaken l.

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s..

.2 4 = = l = i ..., + 3,

cinweps ut.: cances cenici. In the lit..this has meant a physical sieuctme. achieving high'qu.shiy only within a nanow ihscipline or insuiulional coughie. housing many cances related acuuties.1ieipknity, anangemems were n3ade ' The advantays of closeness to piimasy care, pieviou>ly the prmince of alie . wnh othei instientions foi ouisultation ami patient refeiral in a " center-pnvate physician ami commmiity liospital. stunbined wish the demynstrated satelhsef ielan.untnp. Iln> concept was Imther selmed in the Iwi8 sepint of - excePence of the specialized cancer management facdity c.ni be aJiieved " ihe Commitice e,n Radianon Thesap) Sindies. "A Pmspect for Radiatiini .) ilnougli this imique arrangement. t herapy in the thnied States." in whiih - three types of facdities were The pmpose of the organita; ion sa lie desciihed is so coalesce the ~ detailedJ linfortunately, ibis sia.iiiiieauon may generate three levels of j ~ sualified cancer case cunently guaciidd into a lunelionalentity lihe Canees panent case t he lesel of e. ire h.n, thereeine, often been descamined by the . Center) able to ' provide uniform, high. quality patient managenwns. The . p.inenti pinni of enu) into the system, whhh, in sum, depended npim Cincer renact will Ining together she activities of those professional and geographic os ecimomie, conseileiations,L patterns of referral, custom. or technical pessoimel devoted to cancer,.willun an area, who aie capable of ~ . accidens. t hough ecoiiomwally siumd, the development of a testricted moimting such a coopesative endeavor. 'lhese cooperative airangements udi numhet of Inghly centiakeed cances.facdities has the dnadvantage of undoulnedly liillow existing p.allems of activily and will not preclude these separaimg the railiatiim oncologist and other specialisis litun the primasy being some overlapping geographie aieus nr popal.ations sesved. livolutiem of physiaan who sees the cances patient at othes points in the heakh case Cancer Centess should assure shal all patients witn cances aie induded ami system. li a iadianim.oucologist is not available fin consultation at the that no compiment of caneer management sales pl. ace in an isolated os patienti point of entiy into the system, the benents of madiation aie utsen independent environment. 'lhe organizatiimal sinueture recognizes the need for centralization of scaice, highly sLiHed pessonnel ami expetisive equip. lost to the panent. I he pioposal I n a Conpuni Rashalion Oncology Cenier can he a nmdel ment, while at the same time is emphasizes integratimi of all components of toi a nudiiduciphn.ny cancer center lo acineve a comprehensive, functional cances care lium initial diagnosis, thiough definitive e,ne, to sehabilitation enusy embiacmg the total cancer ielated activities of a number of closely. and ongoing management. Radiauon oneohigy is the Leystone for the intenel.ned ami collainnating msiiinnons ami professional innhviduals. The successful oimation of a Cances Ocates. population base,geoysaphic aiea, and number of collaborating inthviilnals aml insutuinns will vaty. Ihneerer, the cardinal < haracteristics icill be multi-Jacipimare cancer care. close mtegration of specsalized cancer care seith - V, SPECIFIC RECOMMENDATIONS FOR RADI ATION ONCOLOGY L pnmarc manseement, connnon utdization of personnel and catuipment, a gn agae, (o,,,ag,,;on oncogogy,,,cy;gye gy,,99,, go,gg,,y, goggu,. single sntem of iccords, and asmrance of optunal care regardless ol' portal of ing specilie accommendations are made: entir.. Ilius, the concept of a " Conjoint Centes"is not one of the center of a . whole cutie of actmiics hui rather it is the cincie iiscif. A. Organization An advantage ut this cimcept is shal, through these ektse coHahunative L se mganitation must instne multidisciplmany involvement in case. an.mgement>, the data hae foi chnical sescanh can eventually be enlanged to nading and diagnosis, the primary management decision, she choice of . mdude essennally all p.itients with cances. 'lliis will i e possible only if the neaunent n ahes, cmWnued manyment, Mow-up, and reliaWation. collaborause an.mgemems aic such as to insme qualilled poiressional Within the Conjoint Radia tion Oncology Center, there must be active evalnanon, compatible seconds, uniform neatment policies, cooperative participation by the following rel.aied disciphnes: smgery, gynecology, cimical invesugation careful and complete follow up, and close conununica-mediea; imcology, radiation oncology, pathology, diagnosue railiology, and iion and miesaenon heiween the pmfessional personnel involved. This will nuclear medicine. SmEciY, gynecology, and medical oncology aie sital, since, lacihtate. iapid tr.msles oi seseaich advances mio chnical piaciite. It can l with radiatiam oncology, aliey offer the cualent therapeutic attematises. provide an ideal enviromnent for liaining in any of the cancer relased

disciphnes by giving e.siensive esperience in a particular disciphne while fd'I".hgy nmst and iii describing and classifying the sumor. 't he nadiological of pasticular impmtance to all uncologtsis for unagmg sluta es a e heightening an areness of the important mies of related disciplines.

decennination of tumor location, site, and response lo : caiment. Respomihihty fin the ' quality of each comgament and dBeiphne will be L Wuhin the Conjoint Radianon uncology Center,a ime confederacy shaied by all p.inicip. mis. It is no longen acceptable. to be cos: tent with must exist between the dif felent compiments of the Conjoint Center, md ima 0 4 9 w

s w .s .a J .s =. f.I 7- - p g y. .J W _** - = - -

• J g

-s g x, ,J d.., 7 =., u "3. 2 O g . g =n 9 3 - s -a = --n

_ =.

U "3 u xu,w .n -s - x ,- n 1 '0 2 5y, 3.7 n x g E. * *.=..~. $- u = 3 _A T T 3m w O g % ~-E

2. T 3

a n f x. 8 4,.. u,.*g y,: J - 4 =,, 4 m. "q y, .-= "3 .s - = -* d e .e M 3 h < J

• g

.O -. 9 - C g.u - "3 =s n J

• g 2.==

.5 = g "s 5 b E sh ~s = - e., 9 u E.=.= y y n - 5, u 5.'" .= = c3 fu e p -=.$,, "E 6" .= - a .,,. = 7 =. - u = a u.=-2 o - 2ll s4 - _ m ,o,,. Aa 9- = o - ~ *,,. u u,.0 4.a .s > e y u e u s .3 a-u ~3 -,' u . u, - M ~-.a u. o,a.c. - Mn ~ -J -u u a n., 5 5 5 - i 4 "E E 3.! $.2. 5,.* O ~ "".l.a n ho u.3 ',d EE ib"E

• 2 -2 af n

s. s .J .n 9 a .x -J N - , g s ..u. o n 2 g =, -! v' ,3 - = x

e =

-q.;. o- -. ..=., x -s - - 9 ..ny - n = .= nJ .3 o - u - r s ..,a, -s.. J. ..s. M.. s u

• d

= ~;.5 .u u.3 -. - .u s 1 .= 8 :=. - c U = ^u 2 =.2 0 = 4 - 7 E.'>W J.- u n 9 o u n - - = .$ -r 3 od x, - w.: se.* =, 1 - . - x :: -= > 2

• 4

=

• s

~ -s u u i .=.,e o = =, =. - - ~ o .. 3.= - 2 =, .,,. 7 3 2 -M =,,. = - _= :s .-3 '. - A .a u u e 6 =

• P

- g 9 .p u =3 y a f =* 7 y .7 .R y og - ss * =.y .a. e s J =.-- u u 9 =- c. .t..- .A. J.q $.2.A -a 3r.,. . =, J. - ~ * * - =g3. =.. = =. *.. =,.. = < = ; - = =sn.

• ^ s 9,
• =

=

• • u'J j

- "3 .=- = .u -. " * -" .y..* g mg =.

• 9 - u -

g y A 9 -s = + "3 1 n $ )"$"""". *** A 9 5 g* w M "u a*J - q .j ") ' = y " .O-3 "'s#".$ g 3 =

• /
• d 2

= 0 d K ~3 = 3 %'.*. - = .d ;#. m. '- - g. -- - m 3 J

• e f O,
• T. _,.-:

= - .: ~> n..., -$g.~. .C O = .J - % =. 3 = { 3 9 u = 7 -

• E
• A. [J =, - de uO 9 2 I 0

."..=,o .3 u m C m -. x s-a .n --- = - n u .o =. u u u n -..'..'"9 e_ .E .-... f. -J

• g = J.s 5 *

s. - = :.*.

9 T 2-y ",3.=.* "3 . **** g -. g 4 .O .-- s J 0_, s n-= 3..- A -s. 9 9 .= . n - -.-- n. -= M. J e -* e.- A -* Q .*'s W.e .= "=, 9 g A

• J-

- g g g A l.Y , *.y

• J J

=3 .p e,b u 'J .g W r

=== E =

• J u%

"O x h$ - gC u *= = .-.,3 r.x'n 3 --3 .2 - - - 7 - n : -. =s .2.n $ -. s.. 2.,..= - c 4 ,u. .n p n x- .o e =. N.

• X

%... __..=,. ,T.*.E.J

== n u J J ,= c J s .J r .g

• =

p. a .g ..U $. =. - m, .s. 8 e J. M h A . n A 3D y ,. g .n. ,J 3,. ,s ,J J + a "3 A 1 h .M A Q .'J ,t g f3 w w. O..,..=>..".3 M. J. 3 .J "n'" 6 - w = ~3

• - * -,, - 9 $

%_ '** =- 3,,8 =s".s .J. - ?y % = .d .N. i n "y

• "5 Q.

'Q * - Q ** = - - "E - - J n m.

1. "J f-

. n

• =.

J j .a u.o

• J-w

.. ~-,,.-.'- p. . gg ,. J o - n. s p re. g s-A .J .A x,w.u.. O,..J

• a s

w -, ', e S "3 ,u, -,g e u.J - g ..=* Q

• .A.= -

. - =.>. =g Q ? '"- - y

• J 0 -

44 Q .A, 3 M p

• 3 y *

== n =-.= -* P. y A -= s u.." g w = u

Q,

: - y

• s "5

",. 'r$ - 9 .d

• E

5..2 2,

-5 [ O = .g = l -.= .1

== ..5 h.r. - -, "3 ~ ~8 0 'E I'N.2 T 0 5 9.= U 3$ *d .E 'd A 3u s. J .J. -.,,,, D .g D, u . a a ,n.,. n.- p

• 's

.J .J,. u. -3 C u g ... e. .s w , n

• A.

.a.*.a W - - g 9- -.J o ..5 .s -- r Q.'.y .J "" _ ** _ <=.- -

• J y ** 9 5

a .J = - y. e ~ -A y, - y- -- . - =.-to

• t-

.A ., u -== = -1 > m ',- - = / - .. =u J , - -,,,. - = -a y -3 p o n,. J - y y J u.: - y :- .=. e s n 4 g ""*',3 - u n u- *- =y== -u -- ? , - - ~ s. = = s s s - u. r., n = u 2 -= = .u. is o ;.= n,,. - $ =. _2 J..u-u ,.=

D

-n- - 3 -a = x - d b *ll: A *, * =. u

== 'O *.-3 =9 3 >s "J i-J -. =. - 3. ej .u. -D3 O T "u "3 o

• s e.s 3

9

• - - =

u 9 =- ..w + = q M y....= =

-

,s. 9.- u .s / g -. u =,--. ~ * *= a.J.4 - - A

• =

= .5 - w -. g .= s _= N N 3 - 't* O - es -.. - -3 u =_. -- Q 5. 'l3 w.h.0 1; - w . u i.c.. .A. "3 u"3 = y _. =.. n i w k w = 2 - o.u y - .o -.x u' 2_ u... = =. ,J p ua = g,,-.~ - = =w - =.... .=

d

- E$i .5 Y '.s h M.".,~ 0 ~ -5 2 = = 3 - o = ' 25-u u - = - 9 .es :.a 9.=

.

- 235=9 .a M -. - E "J 33 .= 2-E, .2 = 2 = ~~ .u. . u = =s. s. .m- - - -er - , = = = .= =. ^ r- .o. u J 3 = =. - - _, _3 = - -. = -

L _ =. =

- u o ,s u c ,n - - ~O E. A. -= *~ ~s j ; 2 :: ~% = '

• ~ -,

.m n n ~3.. - = = s e 0 -.=. .s- = = u - u o J n'. n ^ 2 M.= 0 --t9 y =" O 'u a .- L =- 3 u = - s n = w = E- 'E g 3 = - .4

f.* =". 2 3 = fu.9 = c r =. = n= =.. - - = d %.=.u. = D.=. l-.E3 O O j '= 4y =

.10 3 s 5.E

• -2 5 2 - -

d J

.

= - = 0 qw w 0 .= = - . y =- - = * -

s,

=- - - =.- 0 y32 2,,,5 *- w r u d = v ~

• w x,. _=, 9 = x/

-s

2 r.A ..c a - -e ,... =. u.A _ .a u =.,. -= . - - u 0 .a - a .^ - =. j - =.9 - - -. u.- n= =. _ =. ::. 9 = - -s r =..,g .= =.= - 5.= - 7 =. 9, .=, -n v x ~: s 9 ..= = = - a = .o - - - = *

r..'.

s =- : - : -.- u-3 = u. s - . >.= u-u q = = = r .2, s .:t . =, = --s A n. -.5 =.. =- =

v -.=.

-a -.. g - s .s .a a s =., 2 - n .=.,.. x, - =. -n =.3 *u .m .A - -. =, -..= a .o = s -s =.- .u = a; - = -.. = " ' 2-3 =

4.E 9 C=9 2 5

2.=.::-l u E =y. =., ~e = .s.2 =: ..$==. .J i = =n = : U = c .J =.. _ -.5

- :4 = u - -

o =

y = .. =. = = =. =. .u n 3 - y s _,. u .g 5, =. 9. .s a -s J .... a... -as..: .s -.x . - so -, -= ..*7 .s. _ - . a --"s ,a ,. =- u o .s ,J -s _s g.,.. = - .m -,.,..- = a

• J.

f.- .s- -, - - g j y =._3M x, .s m , - 9. u. .v -.u 9 x4 =, x = .a . =. .J .a . -w ~ E, . 5 g - -1 ,a n -

• u as g

.=., -

u...s. 9.s 5 '5, 3 1 Y

- O .9

• l;" = $."~ - 1 "".

A .s .".f, u._3 J. = "I ej 9k,.= s s - [,. - "lll x-5 C._ 3.s .s. 0 1~ = i s u O o ' ;4 - "5 - w. ::: ? ..s y - * - y s = e - j,,., J - =,.,. ,A .. = - -.- -e = e =, e 4 g 4 =. "l.l[, =.,..g g ,a.9 3_4.. - g. - .s +- - - - = = = - - -3 .J .J A. =% -. _0 .,.y -s g i-.= a u y g, ,= % =. 99 -;.- -.- =.,- - #. - a e s ." =* u, r =

• s

. u .-s -.- .5 L - - a =, s y - '3 ."3 =, .s~ - =..= = .a.i x o ._,. >a.-, . s u 1 ,a ., 9 = -f-e ;,,, -. -.::l: *. r .- u .s .j. n s = =. .A .3 .s = A. A- -l -== A ~

.= ~J -g y 2 _d 'E _.=..-- - =./ -E. '..,.: ' __-: ?.' -. u - - J - - - -

j

= n s 5 9 .,,,,.u s

• f =. - - -=." - _ -

n. *>=s

,,$ - *= - = = = -

• s s

g e .4 y y=q= 2 r A

d=

n.; - ;

=- 4

= . - s g .s =

• g

e =. =.

4 -Q -*3..,:: - ar _ "..;

• e*

,,,y u'. .e e o.s 3 ,p - -. ;l. -S .f. .A a. f. g

• g e

a =..n. o.: X-- = g *. 'g 2 = g - u ... y.= -. g - - - ;,,

• g

-9.* g ;* g .~. = ~3 = '..

• E.

==

• b s

m

- 6 c' >-2 V=9 B.=o.6 T ' 4 -a, ~M l

• nJy2 4_

=~2 :~u.:- - : 2 3

= x, a w<-3. - . y 2.- y o' s - - =.,.2

%_._

nR .S :. u n _- - 9 = v _., - P.x N =. - N.- A n y.. ..~. 9 .e. " *: = 6 = ,a 4 -= ' =.. a-. w = is ,a ~,s .A ~ =.... u _. _ r - - n - s. n.o o n... o n, ba E ': 0 ?s 6t .. n -e. q-25 S-3 s >y,= g.:. C.: s = u_ o -=. o.- _., - = n er.=, 2.. .n a2 .s .s o a .n. --s o . ~ - - o: e.., _y a - - n.,. x23nr. m., - ... v. -.2.,. c. - u ..- - - o.= u,. - o u..=.s.

o

= 5 x .=.._ , x y. y n, :.: 1 n = .= ,s .2 .=. u-v.= ,.e a c, .-. =- n

• n.- - _

n - u,._- ..:< = u s .s. a 3 o 'u c ? =s2. w . c..==. = = 2 ,. o . y = 2 -E 3 u = 5. C 2.2..= 2,x = s g *= _,: u:;.2 c,. 9 .3 ' a ~ C 'C s.,s,= =, x = 2 5 =c 2 y'== C: .r .s =.o x. 2,,.9, x... n,.,. _ i. -u.: .a.n .= 2 - c .3 s ny *d === -s.:-=.x-7, - = - n "= >.. 9., = = . 2 y :: n w = n -. ; -r n' y u 9 u =s = y f 2 - - . = - 3.s C. =. r u. 9 = n- =,, s a a5 c./. ".".; J 9, =., ~ ~y =. ru A -.; E b 5 * =# 5 2 =u g 5.g _~,. x =. 3 ~. ., 2 y. ,e. m. .4

-.

9. 6. .g r,- c. - e .c. ., 9 - 3 .: <. u-s.,o,n n u n v. .- =. 2.= ~

u. :

5 = = e., s _, =. i a , U:. sv 2 c y o 9 0e - A, 9 = '3 __a = - /d 9 =- -9 w g .=. ",t -). . -=. -9 = c M.=- &w = d = = =. =. .s. a .s I n ?. _= n ._.=.E. r =,. :.

• r,.=. ao.

x.,.= ::. - =:. a .s -s y -= - .s = ,.g .s 9.- w s u. - o _ _ - =. y s.= - ,3..,. = _. _n-..u. ..=. m n r ,J . - n =.._ =.. = s n u - - u 3 - -a = 3 .s, - > n >, = .s n - - _o._- n u - _s n ^

s. a

=- . - ~2.. =-. v. n-jF- $2E. !i - - n 1 -. - u 2 ~ n

• - M:$.

5 5 =, 2 -3 -5 *d 5I %25: %Z 3 42s3n

.A.3.o 3

. E :s - .,. _.5 -5.3.a.

./,

4, =y,5 -E.,1, 5 2-C n 7-n x x'. u

• ._= - y s,

3 -- 2.- _s a .=

1. N

.J

• -'^1

- = e ^ 2 s s _. -r 3.s.- y 3 J .=s 9..s" En., - 9'.= -9 ej : - .g 3 '*'s [ A w -m= .e .s w w .9 .s, 8 3,

• J

= v g .,w ,J 9

• J J

3 $ =.= = e - x, ; 9,, "2 $., u s 3 p.,.$. h ~# D 3,. g

• J f

-s ,3.- ) -l = T 'S - = g I n We n s .. n u o 2. - = -z=y s a .- n -., - = _- = u =. n.. = - c r- -.= -s o._ ~- gn - d 3,r. .,, x v .- s = : 2,v.. E > :., g 5b.2 7=- - y $575 2- 0 =.

• n.

= =.E x* 2 . ~ c' .w = pT = .9 ".s,.=.=.9 o_ g n,7_ -.= ,a """i==2 .3 -s IAJ 9 9 =. ?.u t., w A - 9

9.,w - -Q

- = = ~ g u - .a = g - -

.A A.= = 5 9 s = s

= n hw - o =- .s. =s.s . e s v - -22,O = w = .o - - 9-- -s -n ./ A Q. ,.2.7 .n . *s .s.. .a = . 9 ....o e.

• x

=

3 = - -

9 -=..,_7_n "s" =s (, P,,,,,T = "I. = ? - 23 "3 -n

g NB

= - -a e .- n.2 =, a.- Q _, =,, -. .,,w T. =. V., 3,. -= -.,.. =. y .2 4.,,d ,n, s, e, y

• • s oW u

.e J .=, w > a .w .a. u. a -. y .-.= s =s g 4,,. y g - j-w- , 9 a ,a -. ., y 3 w =. z y 20 2. me O". = 9..- .n

• • g;4 _y - 9 =

= 6

'= 9 = -= .=

,; o =* = u

-"I C v = = - - - =, g,9 = .= q. g e 9 -

=

9 = .w =

• s

=,"".s" L 'E e.*,,,. N ,J =.4.,- .=- 7 ~m .-~-s - y., y .-- =-.u ..".3.,=.f O.s y . e. =. : 4 - saa c = y - = y s m o.: *= n yn y w e n. w .n = =. ~w.3, . = J .'s ,J .=,.,.g.s..a e.- O .s ?2 w e e

• =; ~9 g y.j D **'..,= =

p *j u u.- .-.=. ..".3 3..=.=.=,,,, 4 u d e*g . M..f .= 7.d *==O n M a.** 9 u =.T . m w e =_ a. a. 2 = .-=- = = * .d .m. =.u n g e. x~ ~-

- *

.4-7== = 4 u - n E "O 3 = i u *=. _ .g g .s. =. D u 9 a 3.5. ~.s. 3 k *= I = "3.= g %.3. =,. a.. %. g p = = 0 w "3 2 3 4 .e. y 9, e e =T -* V - =.,. s -.. u n g - - y ug n a '.,'s .y & -$ .x,

• d8 O "3 w,

-5O 32w3. 5_. t 2 5 3 x -. S .J - "3 -d5-I

== 7.,.

• d

= 3 - w '*. 5 ~7 o ~3 "3 O - = 7 *, y w O L.M =- 9 = g. =. g - .a=.== c,g - e = i.

.0

..= u =.s 4 - a ig a -=,- g 3 o .=

• s 3 =

[ .,., ; i 9 - n. =- .1 2m n.a .a. O 7 04., i q, M-a - o. f - .s s s w w Nv g .,2 n O q,..=.O. l .e. y = .2~ 2 s

• J

=

• l*

=.* ?g A w u ~5 9 - = - _ =* = y-

w...

.j .. 2 .x 2.. 9 y"3 .J -.=.= - y-

• d a

=y g A s ..e. 2 w L.J 1 -= =- =. f. gZ = - s i g j = 1 g -= ;. = _. ^ 2 =r = ~;. l = -, ' s ^ = =.- n.. ~$ s. g -a - x y - l w. 3 * "d -$.- '3 h 's, ~s g. - s

.~= =

. i 7*'3 2 3 3 -35. L,= -=., g. = d 3 J,. = .. lr.=- -L,

• • n..i n -

=. U Q A _.= x, 39 9*3 =. .a. .J / u - g v .s -. A; -2== t .s . 5 n - ~x a =V 1" 8 L = -O i y

== n ~ ~ = 0 y .d u = - = =: ^ 0.= 2 K s n l. <[ L =. y .l C.- - aur== f = 9,- 6.d ~'.h v( f $55 h n .n 8 'i 3 O'5 I = 7 J .= n-- g

- C a

* 4 y y

0. g 4 O S o o m =

• */
• P

..= M -2

• ll*

l G ': 4 W = .".I. 9_ = t, n - / as .x, st at.=u =.b .1 -..= .J 1 g --

.,

-. "da 9. 3.. 324 32 2 .g 5 e ^ uJ C l =a J, -2 . =. M.- 9 i =J e , -o .= E 1 . = - _ @ U l 9 ^ ~.p -I -".2.=. 4 i ..J - D_ O, r A h e. 'g** -= = a. i .Ao. G. ~-~ ..$ $, y-s I

• s a e - >

i! I .s, - ' l T,,, 3 ?I D 6.,h,,, 5.. 3 l- .y w ."e y g..i ,5 L "=. 'E =.. Y Z "i a --=.$. r- "3 m, = ;- =- f - - -- ' f_a.- ~g = "*= .=..,.]9=_ ,. *f

• ,*)

~- ? a q "".. =*;,

~3

• J I

-z. O ^ - O 5 =- g 79 r 1 =. .- -.. = =. .=,,,s '.< =

• d.,,' ", m

. =. *... r3 ' 0,

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Facility and Equipment Remaiks [, ththovoltag, supesficial x ray generatms and shoit SSD seated somee mashmes aie of value su palh. nave tieatnwn t heir i.se in definitive therapy "E "~ ^' "" '*" P" *"I " "E# should he resuicteilio supesficiallesions,such as those asising in ihe skin aml ~ 1. Such souices must he controlled by the radiation oncologist.

b. Initial consultation Addinonal examining rooms' aie 9

hiteisiinal and intraeavitary radmactive sources should he available in and follow-up nquited; multidisciplinary clinics sec. suft'icient number and vaiiety for a full.mge on cimical use. All such smirecs ununended should he under the contml of the radiatimiimcologist. 7. Operating and secovesy smuns theful for interstitial and intracautany Simulator - A simulator which can acemately seponluce the geometry implants of e.scle extem.d beam treatment tecimique is of great value. Ihere shouhl be 8. Diessing mom and Adespiate in numbes and size; one sinmlator for every two supe voltage units to the Conjoint Cento.Such a waiung soinns einphasis on patiesit dignity mut, and the ticatment planiiing team should be available to all patients tieased by supesvoltage extemal beams, negardless of hication within the g,.ds 'thi Rads;nion Oncology Seivice must y Congonu Radiation Oncology Cenies. It is helpful it the simulator has a have in patient psivileges 10. Domiciliary case As m.my as 8(4 of patient; unJc pmuunn fo Ilnoroscopy alile to visuahze all lield sizes. tieatment need not be in an acute lio> pit al bed. Other f~acilities and Equipment - The following supporting facilities g.acitaies for minimal to moder;de case - and equipment must be available within the Conjoint Center: should be avadsble for patient con-venience and cost ieduction. Facility aml E.guipinent Remarks 1. Computeis foi treatment 'these functions now include tumor II. Day Case With smising supervision for mimu planning d.ita accession, iegistiy, therapy machine con t rol' piocedmes, such as inuavenous in-seineval..md an.dysis enor pievention, ami data logging fusions . 2. hiould o.om Necessaiy for fahiication on individ-12. Chnie.d pimtociaphy FuH puifession.il suite.nallable ualizeit immobilization devices 3. Machine shop Necessaiy for fabrication of heam-D. Hascarch modifying devices and unique items of An active (linical sescaich program is an integral past of a cancer centes equipment U ""* ides an attitude of intellectual inquity and sequires caseful examina I hlust contain dose-measming devices, ' I"" "I. P"'iC"'S ""uiate staging of dawase, and caitical evaluation of sesulas 4. Physics laboratory includmg a secondary dose standaid, 't he patient is olleied a gieater likehhood fm good case with carefully-

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isodose plotters, " phantoms " capa-f"""#' ' ' "' I"""I ""E' "* * "I '"""PY ' I "Y am heu suited f.oi diew simks. ut bility for in riro dosimeuy,and many patien t pmh.N"'

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ts laum the possibility of. new and moie ef fective tocatment and additional iteins of highly 4pecialized equipment. W be hm k iMimalh M mh w hil gid In the clinical osientation of a cances centes,1,asic iescanh in tumos and 5. Electronics shop Capabihty f or maintenance of com-radution biology is mine likely to he relevant to imimitant clinical pnellems plex clectomic equipmcut, faciuding The stimulus for peifonining expeiiments and the caiteiis foi evaluation in radiation simrces, Jose measuring de-this seiting ase closely icl.ited to the patient and his thsease. An advantage in vices and electiome interfacing. 1. 10 0

e VI. CONCLUSIONS - condustmg basie rescatih in t' ter is shat she resuhs of such ,= g ,p Me. espesinwnis aie rapidly transf-designed to piomote integrated c.meen management in the linited States and a single level of optimal case, avoidmg the suanticatism in spiahty >hos tage os i. ..a e oncologista exists and has been the present health case syswm. fhe point. of entry into the s"ystem. E. Tm..nunf geograpine. ecomunie in social cimsiJeianons must nos deteimine. the A m documented in detail in a repon to the National Cancer instiente, entitled quality or avadabdity of case. l'or these purposes, alw closesi possible~ 1 " Crisis in Radiation Therapy -Tiainmg aml Peactice," a summary of which imessanon of all caneci.related aelisities is necenary wuhin a bioad sphere ut appeais in Appendix 1. The expanded role ol' the radiation oncologist as m0nence. ~lhis requises the fonnation of a funesional enuty to embeaee lhese desenhed in this pioposal win furthen inetease the number of traineil aciisities that is much hmades in extent than the tiadnional concept of a pessoimel required. 'the Conjomt Centes will pmvide an execilent enviion-cancer center. the Conjoint Center thus i.ecome> the entire cisele of ment fm the liaining ut the radiation oncologist, as well as of health cances.ietaled activities. the responsibility for execlienee of all compinwnts manpower in all cancennelated slwciahies. mun he shawd by all panicipams. No compiment can grand alone nor is is 'l he radiation oncology trainee wdl pmlit in many ways Imte the acceptable to be content with aclueving high quahiy only within a nanow 1)ineiease in the number and variety of discipline m institutional contine. Therapeutie pmeedmes must be offered in pmposed organizational struenne: f fh hiple a setting of muhidisciplinaiy pasticipatism in management decisions;howevei. . patients seen;2)inteiaesion with hmad based representation o t e tuu I ~ disciplines involved in cancer cate; 3)greatti p.nticipation in primasy the facilities to pesfonn each ilierapeutie ahemative may well he concen management decision; -1) involvement in an miellectually stimulating atmo-naiedin oiw or mme component pasts ut the centes. sphere onlinical and basic iesearch. Crineal shortages of Isained peisonnel e xist in such delsis as radiological phnics, radiation biology, sadiat.on therapy technology,amidosimetry.The COMPLEX AND EXPENSIVE EOulPMENT AND F ACILITIES luoad basis of traimng and expeiience within the Conjoint Center offeis an ARE TO BE EFFECTIVELY UTil12ED FOR THE PURPOSE I unt>sandmg oppostunity for excellent piogiams in these fields, innovative OF MINIMlZING COSTS CONSISTENT WITH illGH OUALIIY appsoaches to continuing education for professional personnel, pubhe CARE. CENTRALIZATION OF TilESE FACILITIES IS OFTEN information, and education will be impossant center activities. THE MOST EFFICIENT MECHANISM FOR ACHIEVING COST IIEDUCTION BUT MUST BE CONSONANT *lTH THE PHl. MARY REQUlHEMENT FOR UNIFORM EXCELLENCE OF PATIENT CARE IHROUGHOUT THE CONJOINT CENTER. implementation of these recommendations will offer specide advan-MOBILITY OF SKILLED PERSONNEL IS NECESSARY TO sages in radiation oncology. Patient service will gain thiough the broader base GUARANTEE Tile AVAILABILITY OF EXPERT OPINION AT J . of pmfenional consultation and personnel available to all components of the EVERY SITE WHERE MANAGEMENT DECISIONS ARE Conjoint Center. Sophisticated equipment and techniques will he utilized MADE AND TilERAPEUTIC PROCEDUllES PERFORMED. opumally and providently. Research and training will be conducted in a nulieu best smied to these activities. This report desenbes a program for sadiation oncology, Cleanly,similar consideranons apply to the other conceractated disciplines. An impostant lxnelit to be accrued from implementation of these recommendations will be the existence of an actively the impact on all areas of cancer management: coopeialmg gioup of radiation oncologists working jointly in a number of institutions will focus attention on the gieat value of such cooperative effort. This group can then be instrumental in promoting active collaimration a langer gionp of smgeons, internists and other physicians to . ame:igst promote a truly inteidisciplinaty, optimal approach to cancer case. i 12 s

m g: % ,= . pait. time piactice of sadiotherapy now wish to' contine their practice to'; diagnostic radiology. The demand for well trained therapists to fill these positions is a second major cause of the crisis, lhe number of such unfdled positions has been determined by an' Ame ican College of Radiology survey' to be 500 to 600. - APPENDIX l I inally there are deficiencies m cancer management related Io the small nher of therapeutic radnylogists. The number of radmiherapists necebany n ..k MARY:'CHISIS IN RADIATIGN THERAPY THAINING to memne thm dehcienms ss huh to detennine. AND PHACTICE Pubthbed by CRTS, September 1972 '

l. Many patients with potenitally radio-curable rancers are not being seen cady enough in radiainm theiapy centeis.1liis depiives the p.auent lhe necil im conmined govesmnene suppois for tsaininr in nadiation of the chance for core.

. oncolor.y h being spicsuoned. 'lhis is m the face of what we have aswssed to

2. Oppoitunities foi clinical and expenment.il rese.irch aitisitics be a emis ' m ia.halion theiapy :aining. Wlole the cument goveimnem-have not been adequately developed in the snaiosity of sadiation theiapy oppmted paining progiants have achieved notable success in esiahhslung centers in the United States primanly fmm a lack of trained therapists.

nnulel liaining (enicis ami a core 'of hirbly skilled pioressional teachess.and

3. Iloth simple and sophisticated radiation therapy techniques are m tiiggesing a nationwide sequence leading to the establishment of a new being used more often because of their demonstrated effectiveness. These -

genciation of :annng piogr.nns. it is clear that our gicatest need soll hes techniques shouhl become soutine, but cannot, because of a lael of . ahead. pioressional help. Bed esthnates am Wat u need user 2,000 practicing radiation .$mee the onset of goveimnent suppoit fo sadiation theiapy training I apists at lumnt m am approMinately 6W pracheing therapists in pocams il.cie lia> been a slow hun steady meiease in the nmnher of dns connuy.1hus the exiding sinntage h sciious and the gap between supply wellliained theiapeutic radiolorists, liy June 1972 these will be b.nely 100 and demand is likely to get worse before it inipioves. Continued govenm,ent sandidates per yeas talmg the annual wusten examination in straight suppu t or ra&ahon therapy training dunng this crish is uigently needed. theiaptune nadiolory. A sinul.n numhet is anusipated in each of the next seresal yeais i Iable 1). It n enenual that thh supply be augmented. TABLE l - Total Number of Physicians in l'ulme needs.ne atIccieil by two inajos changes in patteins of lianiing Training in Radiology Specialties (Trainees are distributed throughout and piactice. 3-or 4 year training period)

1. p.nicins of traming in radiolog) ;uid its subspecialties have ch.niged r adicall). Iloth pmraam duectius. and snunees aie showing decicased Jan.19G8' July 1971" s onunitinen t to the reneral sadiology liaimng pmr. sam and aie developing Noclear Medicine 0

straight. diagnosue and straight theiapemic sadiology. The Dia9tuistic Radintouy 245 1.412 g.soriams m ducsuon ut this ch.mre h.n ecoulted in a maior deciease in the unmhes ut Hadiation Therapy 77 243 o.unces utihnng the pencial sadiolo y " gateway"into theispeutic nadiolog}

• General Hadiology 1,784 1,316 t he nei shaure b.: decicase in the insenbes of phyucians available to piactice Total 2,106 3,038 -

iheiap) esen ihonrh' the suairbt'sheiapy pnpams hase incie.ned the most luyhty :.Lilled component of that specially (l'ahle 11. .,,,,,,u y mca i.pues a.s f rom Dr. liesuy 1%desgrad survey not she Anweecar: 2, % nh the nanonwide impmvement in ilie ilualo) of the apy luucoce. wneuu of Hanson'>w. mam ut ihe vencial i.bholognh who weie (minedy conteiit with then 3 8 '*" ** d"' 8 ")'"

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