AHRQ Report on Proton Beam Therapy Prompts Clinical Trials Comparing the Cancer Treatment to Photon Beam

With the Agency for Healthcare Research and Quality (AHRQ) having reported last November that proton beam therapy is untested in comparing it to other cancer therapies, the push is on to prove the efficacy and safety of this treatment modality, according to a news article in the April 7, 2010, Journal of the National Cancer Institute.

In reviewing 243 articles involving proton beam therapy applied for cancers, the AHRQ researchers found that the studies did not “document the circumstances in contemporary treatment strategies in which radiotherapy with charged particles is superior to other modalities. Comparative studies in general, and randomized trials in particular (when feasible), are needed to document the theoretical advantages of charged particle radiotherapy to specific clinical situations.” Although the authors of this technical brief did not assess outcomes or evaluate the validity of safety claims or the effectiveness of particle beam radiotherapy, they emphasized that these concerns should be addressed in comparative studies.

The authors also noted the greater expense related to the newer therapy. They pointed out that only seven facilities in the United States provide these treatments, with four more under construction or being planned at a cost of $100 million to $125 million per facility. And as the JCNI news article stated, it can be lucrative for practices that can charge up to $90,000 for a proton therapy treatment course under Medicare reimbursement policies compared to half that cost for an IMRT treatment course.

A phase II study by researchers at M.D. Anderson Cancer Center started to recruit patients to compare image-guided adaptive photon versus proton therapy for non-small cell lung cancer. They estimate that the study will be completed by 2012. Another group at Massachusetts General Hospital, which runs one of the seven proton beam cancer treatment centers in the U.S. has submitted a grant to fund a larger study of proton beam therapy for prostate cancer, according to the JCNI news article.

“It (proton beam therapy) hasn’t proven itself to be superior,” said Anthony L. Zietman, M.D., professor of radiation oncology at Harvard Medical School in Boston, who is affiliated with Massachusetts General. “We’ve applied for a comparative-effectiveness grant to do a head-to-head trial with IMRT with the same radiation dose,” he said in the JNCI news release.