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Originally published as JCO Early Release 10.1200/JCO.2008.17.4136 on April 28 2008 © 2008 American Society of Clinical Oncology.
Introducing New Treatments and Technologies Into the ClinicIn this issue of the Journal of Clinical Oncology (JCO), we are publishing a number of articles and letters related to clinical trials and proton therapy. These were ultimately prompted by a review we published on proton therapy by Brada et al,1 who stated in their conclusion: "Before rolling out proton therapy into daily practice, it is necessary to establish its real additional value. This requires well-designed phase II trials and adequately powered phase III trials to provide objective information on the efficacy and toxicity compared with best conventional therapy." They concluded further that "Proton and other particle therapies need to be explored as potentially more effective and less toxic RT techniques. A passionate belief in the superiority of particle therapy and commercially driven acquisition and running of proton centers provide little confidence that appropriate information will become available. Objective outcome data from prospective studies is only likely to come from fully supported academic activity away from commercial influence." Subsequently, other articles on proton therapy have been published, including a paper in this journal on cost effectiveness in prostate cancer by Konski et al.2 This was accompanied by an editorial by Zietman,3 the title of which, "The Titanic and the Iceberg: Prostate Proton Therapy and Health Care Economics," indicated a cautionary note in regard to the cost effectiveness of proton therapy. Underlying these observations is a lack of data from clinical trials, which many would require for rational decision making. Goitein and Cox4 published a Comments and Controversies piece in JCO, entitled "Should Randomized Clinical Trials Be Required for Proton Radiotherapy?" For many clinical trialists, this would be viewed as a self-evident question. However, these authors took the position that randomized controlled trials rarely address all clinical situations, and may not be tenable when one treatment seems theoretically superior: "In deciding whether the arms of a trial meet the equipoise standard, one can only rely on informed judgment. It is our argument that informed judgment leads to the conclusion that proton beam therapy is precisely such a circumstance." It is not surprising that we received a number of letters in reaction to this conclusion. In this issue, we are publishing three of these letters,5-7 with a response by Goitein and Cox.8 One of the letters comes from a patient with prostate cancer,5 who takes the position that it is appropriate to offer proton therapy based on his perception that "the medical community seems to agree that the proton beam is superior to x-rays." However, it is not clear to us that such unanimity exists, and we believe that the medical community has the responsibility to recognize that establishing standards of care that will be applied to large groups of patients often requires the highest levels of evidence. Equipoise, a term that appears in a number of the articles published in JCO, suggests that two sides of an issue are balanced. However, the authors seem to be in some disagreement about whether enough facts are available to justify balance, or indeed whether the outcomes of the therapy are in the balance. We are also publishing two Comments and Controversies,9,10 each taking the middle road, acknowledging that randomized controlled trials may not be feasible for every disease and every clinical situation, but that some well-designed randomized controlled trials in common diseases should be performed. There are examples from radiation oncology of randomized trials to evaluate new technologies, such as testing intensity-modulated radiation therapy for salivary gland preservation in head and neck cancer and accelerated partial breast irradiation after breast conservation surgery. Finally, we should also not forget the lessons learned from high-dose chemotherapy and stem-cell support in metastatic breast cancer—an exciting technology of the times—for which thousands of women received a toxic treatment that was eventually proven ineffective in randomized trials. We are publishing these articles and letters not necessarily to focus on proton therapy, but to explore the complexities of introducing new oncologic treatments, imaging modalities, and technologies—costly or not. We hope that you find these well-written pieces important and instructive. AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest. NOTES published online ahead of print at www.jco.org on April 28, 2008. The Editors of Journal of Clinical Oncology REFERENCES
1. Brada M, Pijls-Johannesma M, De Ruysscher D: Proton therapy in clinical practice: Current clinical evidence. J Clin Oncol 25:965-970, 2007 2. Konski A, Speier W, Hanlon A, et al: Is proton beam therapy cost effective in the treatment of adenocarcinoma if the prostate? J Clin Oncol 25:3603-3608, 2007 3. Zietman AL: The Titanic and the iceberg: Prostate proton therapy and health care economics. J Clin Oncol 25:3565-3566, 2007 4. Goitein M, Cox JD: Should randomized clinical trials be required for proton radiotherapy? J Clin Oncol 26:175-176, 2008 5. Morgan JP: A patient's perspective on randomized clinical trials for proton radiotherapy. J Clin Oncol 26:2592, 2008 6. Macbeth F, Williams MV: Proton therapy should be tested in randomized trials. J Clin Oncol 26:2590-2591, 2008 7. Lewis BE: On equipoise and emerging technologies. J Clin Oncol 26:2590, 2008 8. Goitein M, Cox JD: In reply. J Clin Oncol 26:2593-2595, 2008 9. Glatstein E, Glick J, Kaiser L, et al: Should randomized clinical trials be required for proton radiotherapy? An alternative view. J Clin Oncol 26:2438-2439, 2008 10. Tepper JE: Protons and parachutes. J Clin Oncol 26:2436-2437, 2008 Related Articles
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Copyright © 2008 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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