Authors' objectives:

VHA’s Office of Patient Care Services (OPCS) asked the Technology Assessment Program (TAP) for a review of the literature to identify the level of evidence available as support for proton beam therapy. Specifically, TAP was to identify those cancer diagnoses for which proton therapy has been shown by rigorous research to be effective.
TAP approached its charge through available systematic reviews, guidelines or technology assessments based on such reviews, and economic evaluations using systematic reviews as sources of effectiveness data. This document will refer collectively to these synthesis publication types as “reviews”.

Authors' recommendations: Available reviews for proton therapy generally concur on the state of the literature as consisting primarily of observational studies from which conclusions about the relative effectiveness of proton therapy versus alternatives cannot validly be made.Available reviews generally reflect the state of the literature in that they attempt to cover so much territory (multiple tumors or types of radiation) that the reviews themselves are cumbersome to read, poorly organized, correspondingly difficult to abstract, and provide only diffuse or equivocal conclusions by individual diagnoses. Several reviews attempt ill-advised or inadequately reported statistical combination of results from multiple poor-quality observational studies, further clouding credibility of results from primary studies.In other words, the literature reflects the early clinical investigation status for effectiveness of proton therapy, where observational studies are framed in terms of potential benefits, reasoning from pathophysiology, dose-finding, refinement of treatment protocols, and baseline safety of the entire approach. Only prostate cancer and uveal melanoma are represented by CCTs: in both cases with other significant methods weaknesses.Finally, the availability of studies titled by their authors as “economic evaluations” is misleading. Such studies require cost and efficacy data about both the intervention and its alternatives (costs and consequences of alternative interventions), hence should be conducted only after efficacy data from RCTs are available. In the case of proton therapy, the economic studies are premature, really should be labeled simple cost rather than cost-effectiveness analyses, and their conclusions based on unwarranted efficacy assumptions. Cost data have been carefully collected and reported, but these are only one element of decision making about investment in proton therapy. Weaknesses of currently available economic studies precluded their inclusion here.Explicitly: There are no indications for which proton therapy has been shown unequivocally to be effective, or more effective than its alternatives. No research published subsequent to the searches conducted for available systematic reviews has changed the conclusions of those reviews.

Project Status: Completed

URL for project: http://www4.va.gov/VATAP/docs/protontherapycancerupdate2010.pdf

Year Published: 2010

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: United States

Organisation Name: VA Technology Assessment Program

Contact Address: Liz Adams, VA Technology Assessment Program, Office of Patient Care Services (11T), VA Boston Healthcare System Room 4D-142, 150 South Huntington Avenue, Boston, MA 02130 USA Tel: +1 617 278 4469; Fax: +1 617 264 6587;

Contact Name: elizabeth.adams@med.va.gov

Contact Email: elizabeth.adams@med.va.gov

Copyright: VA Technology Assessment Program (VATAP)