Speaking of proton beams , while they populate like rabbits in the US based on a financial model that includes overpayment for prostate irradiation, there are real debates going on in Europe about their efficacy. Here are excerpts from an article from the British Medical Journal Critics say the NHS should not be spending so much money on a treatment that has not been subjected to randomised controlled trials and for which there is little evidence of long term efficacy or safety. In April, an article in the BMJ questioned whether the government’s £250m investment was premature. “For most indications,” reported a review of the evidence in February, no firm conclusions could be drawn about the superiority of protons over photons and it was “sobering to observe that no phase III trials have been performed.”
The debate has been clouded in the UK by a focus on the widespread use of proton therapy in America for the treatment of prostate cancer. This is a red herring, says Adrian Crellin, a consultant clinical oncologist at St James’s University Hospital, Leeds and the Department of Health’s national lead for proton beam therapy: “We have quite specifically excluded prostate cancer as a standard indication for treatment because there’s no evidence.”
In fact, the application of proton therapy in the UK is limited to just 15 rare cancers— three adult and 12 paediatric—that have the clearest evidence, including base of skull chordomas and chondrosarcomas and primary paraspinal tumours. Referrals to overseas treatment centres, which will continue until the NHS units are up and running in 2017, are subject to approval by a national clinical panel that takes account of a range of other factors, including the timing of radiotherapy in relation to other treatment and the stage and pathology of the cancer.
Roelofs explained that the Netherlands takes a somewhat cautious approach when it comes to introducing new treatment regimes, as evidenced by its health insurance board, which will only reimburse proven technologies. For many years, there was concern about the lack of evidence for proton therapy, a situation that led to the instigation of ROCOCO - an ongoing international multicentric in silico trial comparing photons, protons and carbon ions.
The idea is that before a patient is referred for proton therapy, simulated plan comparisons must reveal a significant dosimetric benefit of protons. This advantageous dose distribution then needs to be translated into clinical benefits, such as reduction of side effects, using proven complication prediction models. "This general in silico concept was picked up by the health insurance board to be enough evidence to reimburse," Roelofs said. The board has stated four model-based indications: head-and-neck, lung, prostate and breast cancer, where patients are eligible for reimbursement, as well as the standard indications: intraocular tumours, chordoma/chondrosarcoma and paediatric tumours.
But they recognize that the jury is still out and so study is needed.
Another government requirement is that all patients treated with protons in the new centres are included in standardized clinical trials with uniform outcome measurement, requiring close collaboration between sites. "All four initiatives have been working on this proposal for years, so there's already good collaboration between them," Roelofs explained. "We're working together to set up one registry for protocols. When you have four centres treating in the same way, collecting the data in the same way, this will enable you to perform comparisons more easily. I think it will help create the evidence for proton therapy that is still needed."
In the US, there is not a requirement that efficacy be demonstrated. Only safety. So the capital markets have leaped on the technology as a way to draw in the dollars. Hospitals sign the mortgage to create a competitive advantage. The medical arms race continues, enhanced by a national association !