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Brendon Nafziger, DOTmed News Associate Editor | March 28, 2012
In general, he follows, and cites, the approach laid down by Herman Suit and his colleagues in Radiation and Oncology in 2008, who also argued there was "no medical rationale" for the clinical trials and who believed the money used for such trials would be better spent on "real problems," such as dose fractionation and combined modality therapy. "Based on present knowledge, there will be some gain for patients treated by proton beam techniques. This is so even though quantitation of the clinical gain is less secure than the quantitation of reduction in physical dose," they wrote. "Were proton therapy less expensive than X-ray therapy, there would be no interest in conducting phase III trials."
More RCTs please
But Dr. W. Robert Lee, a radiation oncology professor at Duke University, is having none of it. His objection is principally philosophical. "To assert that proton therapy is superior to photon therapy in the absence of rigorous evidence is to engage in faith-based medicine," he said.
"To date, there are no randomized controlled trials comparing proton therapy to photon therapy in any clinical scenario. To aver that proton therapy does not require this level of evidence when claims of superiority are made implicitly suggests that proton therapy is supernatural, beyond the limits of the natural world; in short, magic," he added.
He also argues that inherent superiority of protons is not clear cut. There have been studies, dating back to the mid-1970s, suggesting protons carry their relative biological effectiveness past the peak. In any case, he says, treatment-planning studies cannot replace RCTs for this issue. For instance, two recent treatment-planning studies have been inconsistent, and as we know little about dose-volume relationships, it would be imprudent not to rely mainly on real clinical results, he argues.
"Randomized trials are the best method to test hypotheses, and the proton beam lends itself to many hypotheses that can be tested," he said.
Read the whole debate here: http://online.medphys.org/resource/1/mphya6/v39/i4/p1685_s1?view=fulltext&bypassSSO=1
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