For the first time ever, the 2 medical organizations most responsible for the treatment of prostate cancer in the United States have issued a joint guideline.
The American Society for Radiation Oncology (ASTRO) and the American Urological Association (AUA) announced the publication of a guideline on radiation therapy after prostatectomy (both adjuvant and salvage) at the AUA 2013 Annual Scientific Meeting held in San Diego, California.
“The purpose of this guideline is to provide a clinical framework for the use of radiotherapy after prostatectomy in patients with and without evidence of prostate cancer recurrence,” write the guideline authors, led by ASTRO’s Richard K. Valicenti, MD, from the University of California Davis Comprehensive Cancer Center in Sacramento, and the AUA’s Ian M. Thompson, MD, from the Cancer Therapy and Research Center at the University of Texas Health Science Center at San Antonio.
“We hope the guidelines will facilitate discussion between physicians and patients about the use of radiation therapy,” Dr. Valicenti told Medscape Medical News in an interview. He said that the discussion should include the benefits, adverse events, and quality of life associated with the treatment.
The data-dense document considered 324 research articles and is the fruit of the Radiotherapy After Prostatectomy Panel, a collaboration that was created in 2011 by the 2 groups. Only studies in which prostate-specific antigen (PSA) data were provided for at least 75% of patients were included in the guideline.
The bottom line, once again, is that PRT is a technology that is at least 30% more costly than IMRT, with no clear evidence that it does reduce long-term side effects, and absolutely no data to show that it provides better outcomes. Yet the government continues to pay more money for it. I read an analysis that shows the extra expenditure from PRT could reach $100 million/year. It will cost $15 million to do a prospective randomized trial, which is underway at Massachusetts General Hospital and University of Pennsylvania.
The recommended strategies and approaches are derived from evidence-based and consensus-based processes in the reviewed articles. “This document constitutes a clinical strategy and is not intended to be interpreted rigidly,” write the guideline authors.
The literature that undergirds the guideline has a “major limitation” — the “lack of a large number of randomized controlled trials to guide decision-making in patients with and without evidence of recurrence,” they note.
There was a similar data problem regarding the appropriate use of androgen-deprivation therapies (ADT), so the guidelines include no instructions about ADT.
The lack of top-flight data means that the guideline has only 1 statement with an evidence strength of grade A (high quality, high certainty). In short, the guideline’s statements are based mostly on less stellar quality/certainty data or on expert opinion.
The guideline document offers 9 major statements, which fall into different categories — clinical principles (wide agreement by urologists), recommendations (grade C; low-quality and certainty evidence), standards (grade A or B; high/moderate-quality and certainty evidence), and options (nondirectives).