National Cancer Institute Workshop on Advanced Technologies in Radiation Oncology December 1, 2006

1. National Cancer InstituteWorkshop on Advanced Technologies in Radiation OncologyDecember 1, 2006

2. Edward C. Halperin, M.D., M.A.Dean of the School of MedicineFord Foundation Professor of Medical EducationProfessor of Radiation Oncology, Pediatrics, and HistoryUniversity of Louisville

3. The Club of Radiation Oncology Deans Samuel Hellman Allen Lichter Edward Halperin

4. Active Membership = 1

6. I have therefore concurred with myself and can assure you that the following views represent the unanimous opinion of the active membership.

7. Charge per Dr. Vikram’s email of 8/17/06

8. Compare, in reference to toxicity and survival, for childhood cancer, radiotherapy with conformal v. stereotactic v. IM/IGRT v. proton, neutron, carbon ions, pions et al. techniques

9. Outline Is the question(s) moot? Is the answer(s) self-evident? What questions didn’t Dr. Vikram ask that he should have? What do the data show in reference to the charge I have been given? What shall we do?

10. Is the question(s) moot?

11. ACGME Requirements in Radiation Oncology for Residency Training “The clinical core curriculum shall include experience in . . . pediatric [tumors]. . . . Residents must treat no fewer than 12 pediatric patients [in 4 years of residency] of whom a minimum of 9 have solid tumors.”

12. On 10/12/06 there were 79 accredited radiation oncology residencies in the U.S. with 569 residents on duty or ~ 142/year.

13. An estimate of the number of pediatric radiation oncology patients per year in the U.S. available for residency training and, potentially, for investigation of radiation treatment modality

16. ….big assumptions: No cases go to private practice.Cases are uniformly distributed (Wills, St. Jude, MSKCC, CHOP, etc)

17. Example: ALL (CNS prophylaxis, testicular relapse, TBI) 124 cases/year ÷ 569 trainees = 0.2 cases/year/trainee

18. So, in a 4-year residency, casting aside the problem of the “big assumptions,” our trainee will see 0.8 cases of the most common malignancy of childhood.

21. “The only thing I really want to know about pediatric radiotherapy after finishing this residency program is your phone number.”

22. “… if you want to lead, you have to adjust to the environment in which you find yourself. You cannot wait for it to adjust to you.”J.L. Gaddis, describing Dean Acheson. New Republic, 10/16/06, p.28

23. Many people assert that the Watergate scandal demonstrates that a free press is essential to democracy. All forms of print and electronic press are pleased to take credit for this achievement.

24. It can be argued, however, that it wasn’t the press at large who broke the Watergate story, it was two Washington Post reporters: Woodward and Bernstein.

25. Similarly, we have all seen dramatic images used to promote IMRT/IGRT and proton therapy in childhood tumors. It would be wrong to promote this technology on the basis of, from a public health standpoint, a tiny number of cases.

26. It is disingenuous to show your hospital administrator proton dosimetry for treating childhood craniopharyngioma as a technique for getting him/her to buy protons for treating bone metastases.

28. Is the answer(s) self-evident?

29. “There is never any reason to give any dose to uninvolved normal tissue. An increase in dose to the tumor will, to a point, improve local control. Achieving these objectives is self-evidently true and does not require randomized prospective trials.”

30. After all, we didn’t require randomized trials to prove the benefits of _____________. Simulators LinAc v. Co60

31. Maybe we should have.

32. “Change is inevitable. Progress is optional.”A. Stern, quoted in Penn. Gaz., 11/12/2006, p. 54

33. Set the bar of proof higher when the price is higher.

35. The Aspirin Analogy

36. Of ~56 African countries, 64% have no radiotherapy facilities.Lancet Oncol, 2004;5:695

37. In Africa in 2002, the supply of Co60 and linear accelerators was 18% of the estimated need.Lancet Oncol 2006;7:584

40. Perhaps we should worry more about the provision of services to more of the world’s population, and less about inordinately expensive machines of unproven benefit for the wealthy?

41. “… in a world where more of the 100 largest economic entities are companies (52) than countries (48), a new set of rules will inevitably apply.”Penn. Gaz., 11/12/2006, p. 54

42. Is the answer self-evident?

43. These are some sites/situations in which the target is such that it is nearly impossible to envision an improvement by new technology over standard techniques.

44. The target is the entire structure and, while IMRT/IGRT could be used to deal with tissue heterogeneity, that is likely to be “a long run for a short slide.” Also, with current technology IMRT may increase second malignant neoplasms.

46. TBIProphylactic cranial irradiationTesticular relapse radiotherapyWhole abdomen irradiation to 10 Gy

47. For some diseases the local control rate is dismal, few children live to suffer late effects, dose escalation has generally been fruitless, and high LET therapy has either been without benefit or made a bad situation worse.

49. Brain stem gliomaHigh grade supratentorial astrocytoma

50. For some diseases, the radiation dose is so low that it is hard to imagine a discernable benefitto technological innovation. (A better dose distribution does not equal a discernable benefit.)