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Proton therapy for prostate cancer: time for evidence
Editorial
On June 4, 2014, the American Society for Radiation Oncology (ASTRO) released its model policy on the use of proton beam therapy. The model policy is not intended to be a clinical guideline, but is the Society’s recommendation for coverage policies. The document assigns various conditions to categories based largely on the strength of evidence about effectiveness for treatment with proton beam therapy. While the report states that sound evidence exists for the use of proton therapy in diseases such as ocular cancers, skull-base tumours, some spinal tumours, primary hepatocellular carcinoma, and various paediatric cancers, the recommendation on the use of proton therapy for prostate cancer is particularly notable—ASTRO states that the evidence for efficacy is not clear cut, and proton therapy is not recommended for the primary treatment of prostate cancer outside of a prospective clinical trial or registry. In the USA, proton therapy is most commonly used for prostate cancer, despite there being little evidence for its superiority over standard photon-based radiotherapy or brachytherapy in this setting. Research does suggest that many men who develop prostate cancer do not need any treatment, because their disease is unlikely to progress in a clinically meaningful way during their lifetime. Ardent supporters of proton therapy actively promote it by selectively highlighting research that shows positive findings. However, ASTRO’s emerging technology committee produced an evidence-based review of proton therapy in 2012 highlighting the fact that there was no sound evidence to support the use of protons in preference to conventional radiotherapy for patients with prostate cancer; neither technique had been shown to give improved results over the other with respect to disease control or toxicity. So why is prostate cancer the most common indication for proton therapy referrals despite there being no evidence base to support it? Some argue that overtreatment of prostate cancer using proton therapy is being driven by three factors: first, the high costs of building and running these facilities (indeed, setting up a new centre can cost up to US$235 million, and the National Association for Proton Therapy states that 14 proton therapy centres are currently in operation in the USA, with another ten under construction); www.thelancet.com/oncology Vol 15 July 2014
second, patient pressure and the risk of patientinitiated legal action; and third, the vast profits these centres can generate—as much as $50 million per year. Unsurprisingly, proton therapy carries far higher reimbursement costs than photon therapy. Some data show that Medicare pays out a median of around $19 000 for a full dose of photon therapy for prostate cancer, but $32 000 for the equivalent proton therapy. The controversy surrounding overuse of proton beam therapy in prostate cancer, and the huge financial implications of such therapy are thus likely to be the cause of the ASTRO document singling out prostate cancer as the only malignancy of those assessed not to be deemed suitable for proton therapy. Certain reforms in the US health-care system have been championed by Medicare to drive down costs, but there is little sense in continuing to reimburse almost double for a treatment that has no proven benefit over more economic alternatives. Advocates of proton therapy say that it will be harder to drive down the costs if its use is restricted, but Medicare’s role is not to fund expensive treatment in the hope that it becomes cheaper in the long run. However, the tide might be turning for proton therapy in prostate cancer. Some insurers have indicated they will no longer pay out for patients with prostate cancer to receive this expensive therapy. At the second annual conference of the National Association for Proton Therapy in April, 2014, speakers commented that the proton beam therapy industry must broaden its focus and end its reliance on prostate cancer because of the number of cheaper and equally effective treatments. Now that a leading radiotherapy society has firmly stated the lack of justification for promoting proton beam therapy over conventional radiotherapy for prostate cancer, deluding patients with false hopes of much more effective treatment with vastly reduced side-effects must stop; pumping huge sums of money from limited health-care budgets into unnecessarily expensive treatments is morally repugnant. ASTRO has called for comparative studies, and resources should now be diverted from indiscriminate use of proton therapy into large, definitive prospective trials to truly define the best settings for this modality. ■ The Lancet Oncology
David Gifford/Science Photo Library
Proton therapy for prostate cancer: time for evidence
For the ASTRO model policy document see https://www. astro.org/uploadedFiles/Main_ Site/Practice_Management/ Reimbursement/ASTRO%20 PBT%20Model%20Policy%20 FINAL.pdf For the ASTRO emerging technologies committee report see Radiother Oncol 2012; 103: 8–11
775
On June 4, 2014, the American Society for Radiation Oncology (ASTRO) released its model policy on the use of proton beam therapy. The model policy is not intended to be a clinical guideline, but is the Society’s recommendation for coverage policies. The document assigns various conditions to categories based largely on the strength of evidence about effectiveness for treatment with proton beam therapy. While the report states that sound evidence exists for the use of proton therapy in diseases such as ocular cancers, skull-base tumours, some spinal tumours, primary hepatocellular carcinoma, and various paediatric cancers, the recommendation on the use of proton therapy for prostate cancer is particularly notable—ASTRO states that the evidence for efficacy is not clear cut, and proton therapy is not recommended for the primary treatment of prostate cancer outside of a prospective clinical trial or registry. In the USA, proton therapy is most commonly used for prostate cancer, despite there being little evidence for its superiority over standard photon-based radiotherapy or brachytherapy in this setting. Research does suggest that many men who develop prostate cancer do not need any treatment, because their disease is unlikely to progress in a clinically meaningful way during their lifetime. Ardent supporters of proton therapy actively promote it by selectively highlighting research that shows positive findings. However, ASTRO’s emerging technology committee produced an evidence-based review of proton therapy in 2012 highlighting the fact that there was no sound evidence to support the use of protons in preference to conventional radiotherapy for patients with prostate cancer; neither technique had been shown to give improved results over the other with respect to disease control or toxicity. So why is prostate cancer the most common indication for proton therapy referrals despite there being no evidence base to support it? Some argue that overtreatment of prostate cancer using proton therapy is being driven by three factors: first, the high costs of building and running these facilities (indeed, setting up a new centre can cost up to US$235 million, and the National Association for Proton Therapy states that 14 proton therapy centres are currently in operation in the USA, with another ten under construction); www.thelancet.com/oncology Vol 15 July 2014
second, patient pressure and the risk of patientinitiated legal action; and third, the vast profits these centres can generate—as much as $50 million per year. Unsurprisingly, proton therapy carries far higher reimbursement costs than photon therapy. Some data show that Medicare pays out a median of around $19 000 for a full dose of photon therapy for prostate cancer, but $32 000 for the equivalent proton therapy. The controversy surrounding overuse of proton beam therapy in prostate cancer, and the huge financial implications of such therapy are thus likely to be the cause of the ASTRO document singling out prostate cancer as the only malignancy of those assessed not to be deemed suitable for proton therapy. Certain reforms in the US health-care system have been championed by Medicare to drive down costs, but there is little sense in continuing to reimburse almost double for a treatment that has no proven benefit over more economic alternatives. Advocates of proton therapy say that it will be harder to drive down the costs if its use is restricted, but Medicare’s role is not to fund expensive treatment in the hope that it becomes cheaper in the long run. However, the tide might be turning for proton therapy in prostate cancer. Some insurers have indicated they will no longer pay out for patients with prostate cancer to receive this expensive therapy. At the second annual conference of the National Association for Proton Therapy in April, 2014, speakers commented that the proton beam therapy industry must broaden its focus and end its reliance on prostate cancer because of the number of cheaper and equally effective treatments. Now that a leading radiotherapy society has firmly stated the lack of justification for promoting proton beam therapy over conventional radiotherapy for prostate cancer, deluding patients with false hopes of much more effective treatment with vastly reduced side-effects must stop; pumping huge sums of money from limited health-care budgets into unnecessarily expensive treatments is morally repugnant. ASTRO has called for comparative studies, and resources should now be diverted from indiscriminate use of proton therapy into large, definitive prospective trials to truly define the best settings for this modality. ■ The Lancet Oncology
David Gifford/Science Photo Library
Proton therapy for prostate cancer: time for evidence
For the ASTRO model policy document see https://www. astro.org/uploadedFiles/Main_ Site/Practice_Management/ Reimbursement/ASTRO%20 PBT%20Model%20Policy%20 FINAL.pdf For the ASTRO emerging technologies committee report see Radiother Oncol 2012; 103: 8–11
775