Proton beam therapy systems are approved by the FDA 510(k) process as a “medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation” (FDA, 2006). Examples of such systems are the Optivus Proton Beam Therapy System (Optivus Technology Inc., Loma Linda, CA) and the IBA Proton Therapy System-Proteus 235 (Ion Beam Applications S.A., Philadelphia, PA).
The Agency for Healthcare Research and Quality published a 2009 technology report on particle beam radiation therapies for the treatment of cancers including skull base and brain tumors. They noted that there is a proposed advantage of using particle beam therapy, including PBT, where precise radiation targeting is critical in tumors of the skull base and tumors adjacent to the brain and brain stem. The report concluded that studies on charged particle therapy “do 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”.
Y. Lievens, W. den BogaertProton beam therapy: Too expensive to become true?. Radiotherapy and Oncology, Volume 75, Issue 2, Pages 131-133 2005
Semenova J .Proton beam radiation therapy in the treatment of pediatric central nervous system malignancies: a review of the literature. J Pediatr Oncol Nurs. 2009 May-Jun;26(3):142-9. Epub 2009 May 21.