ML20236U872
Text
-- -
f ',, i Melvin L. Griem, M.D.
Member,ACMUI,NRC 44 Sunset Trail, Box 453 Ogden Dunes, Ind.46368 Jan.6,1987 Mr. Vandy L. Miller, Chief Material Licensing Division Division of Fuel Cycle and Material Safety Nuclear Regulatory Division Washington, D.C. 20555
Dear Mr. Miller:
I have read your memorandum of January 2, 1987 and in particular Enclosure 2 of the Draft Advance Notice and Draft Final Rule which would be Amendments to 10 CFR Part 35 regarding mis-administrations. There are a number of errors in this draft which may ultimately reflect on the NRC and its advisors.
Page 3 of enclosure 1 has suggested doses of treatment yet for a squamous cell carcinoma of the larynx the prescription is wrong for external beam treatment. Likewise the brachytherapy dose is incorrect if this were the only treatment for a small epithelial tumor of the cervix or of the oral cavity. Such recommendations are used by the legal profession to generate law suits. Should the NRC be part of the practice medicine which is what such statments might be used for?
Modern treatment planning has recently been reviewed in a treatment planning course book published by the Radiological Society of North America last month by Paliwal and Griem.
That book has detailed treatment planning for megavoltage and Cobalt external beam treatment and has an excellent chapter by McGee on the Paris method for dose calculations for brachytherapy. This text also contains the quality assurance (QA) procedures both from the physician's and physicist's point of view. You can obtain a copy for $20 from the Radiological Society of North America,1415 W. 22nd St. Tower e B, OAK BROOK, IL.,60521. Also see Int. J. Rad.
g@ Onc. Bio. Phys.Vo] 10, Supp 1.
l 5 Enclosure 2 has some major errors as well. The number of l m@ patients treated on Cobalt teletherapy has decreased l g$ significantly in the last several years and my estimate is I e n that it is less than 75,000 new patients per year treated on l
o N Cobalt 60 machines. There are 400,000 new patients per year treated with radiation in the U.S.A. Most radiation 3e# therapists see about 200 new patients per year. (World Health l
@@$ Organization data) There are 1896 active and 112 associate members of The A erican Society for Therapeutic Radiology and j
,, L
(
. a d.
I I Oncology (ASTRO) suggesting that there are about 2000 l radiation therapists in the U.S.A. based on the ASTRO membership. There are about 1200 centers in the U.S. Most centers have traded in the old Cobalt machine for 4 MEV accelerators and the move is now the machines with electron capabilities in the 10 to 25 MEV range with photon capabilities at these energies as well. Most Cobalt units remain in small hospitals treating less than 100 patients per year on such units where coverage may be part time both for physics and for radiation oncology.I would be happy to gather this type of data for you. This new rule will not significantly impact the major external beam therapy now being done with accelerators in most major cancer centers, hospitals and treatment facilities in the U.S. On the other hand brachytherapy is being used to a greater extent than indicated by your figures. It is used for treatment of carcinoma of the cervix (15000/yr.) prostate (6000 or more/yr.) breast (over 6000/yr.) endometrium (1500/yr.) head and neck (2000/yr.) brain (1000/yr.) and miscellaneous 4000 to 5000/ yr. There is an Endocurie Society who mig? - 5e consulted for further data. My estimate suggest. .at brachytherapy procedures are increasing.
The ability to maintain a figure of 7-10 % suggested on page 4 of enclosure 2 may be difficult for interstitial therapy and the actual gradients of dose in a volume implant may be much greater particularly near the implanted source.
If the number of sources used is large in an implant the hand calculations may not give the less than 10% precision suggested in this draft. Likewise physical measurements of a brain implant with dosimeters may be risky and there are other sites where permanent implants are used where physical dosimeters may be difficult to use. This is discussed on page 10 of the enclosure 2.
Most centers charge for TLD measurements and some of these suggestions will add to the cost of treatment and may not be paid for by HM0's and some prepaid health plans. Physical measurements are suggested on page 10, Enclosure 2.
The question of whether a licensee can check the arithmetic ially in patient's charts seems to be excessively strict.
Enclosure 2 page 20.
Should " source strength" be in Roentgens per hour at one meter? Should dose be specified in Gy.7 Should the other S.I. units for radioactivity be used? Some Eastern centers have switched to the Gy. for absorbed dose specification and several centers are using the Bq. for radioactivity.
Enclosure 2 page 16.
Part 35.43 Enclosure 2 page 16 (a) this is unclear, as to who is really in charge and assumes the responsibility for the treatment planning.
4
,1 r
." 3 The rest of page 17 Enclosure 2, page 18, 19 and the top of page 20 seem to be all right. I have already questioned part 35.654 (c) the daily aritkaetic. The (d) statement is vague on page 20.
I hope these observations are helpful.
Please contact me at work 312-702-6883 (new phone number) or at my home 219-762-5209 if you have any questions.
y urs, i Sincer ,
M ik em,M.D.
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- Melvin L. Griem, M.D.
Member,ACMUI,NRC 44 Sunset Trail, Box 453 Ogden Dunes, Ind,46368 Jan.6,1987,
- Mr . Vandy L. Miller, Chief Material Licensing Division Division of Fuel Cycle and Material Safety Nuclear Regulatory Division Washington, D.C. 20555 4
Dear Mr. Miller:
I have read your memorandum of January 2, 1987 and in particular Enclosure 2 of the Draft Advance Notice and Draft Final Rule which would be Amendments to 10 CFR Part 35 1 regarding mis-administrations. There are a number of errors { in this draft which may ulitaately reflect on the NRC and its advisors. Page 3 of enclosure 1 has suggested doses of treatment.yet 8 for a squamous cell carcinoma of the larynx the prescription is. wrong for external beam treatment. Likewise the brachytherapy dose is incorrect if this were the only treatment for a small epithelial tumor of the cervix or of the oral cavity. Such recommendations are used by the legal profession to generate law suits. Should the NRC be part of the practice medicine which is what such statments might be used for? Modern treatment planning has recently been reviewed in a treatment planning course book published by the Radiological Society of North America last month by Paliwal and Griem. That book has detailed treatment planning for megavoltage and Cobalt external beam treatment and has an excellent chapter i by McGee on the Paris method for dose calculations for brachytherapy. This text also contains the quality assurance (QA) procedures both from the physician's and physicist's point of view. You can obtain a copy for $20 from the Radiological Society of North America,1415 W. 22nd St. Tower , l :B, OAK BROOK,.IL.,60521. Also see Int. J. Rad. ! . Onc. Bio. Phys.Vol 10, Supp 1. l Enclosure 2 has some major errors as well. The number of I patients treated on Cobalt teletherapy has decreased i significantly in the last several years and my estimate is that it is less than 75,000 new patients per year treated on Cobalt 60 machines. There are 400,000 new patients per year l treated with radiation in the U.S.A. Most radiation 1 therapists see about 200 new patients per year. (World Health Organization data) There are 1896 active and 112 associate members of The American Society for Therapeutic Radiology and j ( Y Y. Y f* }
.c.
?
Oncology (ASTRO) suggesting that there are about 2000 radiation therapists in the U.S.A. based on the ASTRO membership. There are about 1200 centers in the U.S. Most 1 centers have traded in the old Cobalt machine for 4 MEV I accelerators and the move is now the machines with electron I capabilities.in the 10 to 25 MEV range with photon { capabilities at these energies'as well. .Most Cobalt units '
. remain in small hospitals treating less than 100. patients per year on such units where coverage may be part. time both for j
' physics and for radiation oncology.I would be happy to gather I this type of data for you..This new rule will not i significantly impact the major external beam therapy now I being.done with accelerators in most major cancer centers,
' hospitals and treatment facilities in the U.S. On the other hand brachytherapy is being used to a greater extent than ,
indicated by your figures. It is used for treatment of i
-carcinoma of the cervix (15000/yr.) prostate (6000 or I more/yr.) breast (over 6000/yr.) endometrium (1500/yr.) head and neck (2000/yr.) brain (1000/yr.) and miscellaneous 4000 to 5000/ yr. There is an Endocurie Society who might be consulted for further data. My estimate suggests that brachytherapy procedures are increasing.
The ability to maintain a figure of 7-10 % suggested on I page 4 of enclosure 2 may be difficult for interstitial therapy and the actual gradients of dose in a volume implant may be much greater particularly near the implanted source. If the number of sources used is large in an implant the hand calculations may not give the less than 10% precision suggested in this draft. Likewise physical measurements of a brain implant with dosimeters may be risky and there are other sites where permanent implants are used where physical dosimeters may be difficult to use. This is discussed on page 10 of the enclosure 2. Most centers charge for TLD measurements and some of these suggestions will add to the cost of treatment and may not be paid for by HM0's and some prepaid health plans. Physical measurements are suggested on page 10, Enclosure 2. The question of whether a-licensee can check the arithmetic daily in patient's charts seems to be excessively strict. l . Enclosure 2 page 20. L Should " source strength" be in Roentgens per hour at one I meter? Should dose be specified in Gy.? Should the other I S.I. units for radioactivity be used? Some Eastern centers 1 have switched to the Gy. for absorbed dose specification and several centers are using the Bq. for radioactivity. Enclosure 2 page 16. Part 35.43 Enclosure 2 page 16 (a) this is unclear, as to who is really in charge and assumes the responsibility for the 3 treatment planning. L_- . __ l
.,,. t ,
n The rest of page 17 Enclosure 2, page 18, 19 and the top of page 20 seem to be all right. I have already questioned part 35.654 (c) the daily arithmetic. The (d) statement is vague on page 20. I hope these observations are helpful. Please contact me at work 312-702-6883 (new phone number) or at my home 219-762-5209 if you have any questions. Sincer 1/ y urs, ef 1 iem,M.D. ____ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _._ _}}