To conduct a meta-analysis of the randomized controlled trials (RCTs) comparing adjuvant radiotherapy (ART) to wait-and-see (WS) strategy in pathologic T3 or margin-positive prostate cancer.
A comprehensive EMBASE, MEDLINE, http://www.clinicaltrails.gov, and Cochrane Library search for RCTs of ART versus WS was done. Results were synthesized for metastasis-free, biochemical progression-free, clinical progression-free, hormone-free, and overall survival as well as gastrointestinal (GI) and genitourinary (GU) toxicities. Either random-effects model or fixed-effects model were used based on the test of heterogeneity.
Three RCTs (EORTC22911, SWOG8794, ARO96-02/AUO-AP09/95) were identified with 1737 patients. ART resulted in greater biochemical progression-free survival (hazard ratio [HR]=0.48, P<0.00001) including benefit in all subsets, greater clinical progression-free survival (HR=0.73, P=0.0003) including benefit in subsets with margin-positive or seminal vesicle invasion and, greater hormone-free survival (HR=0.64, 95% confidence interval, 0.51-0.80, P=0.0001). Ten-year metastasis-free survival was significantly improved with ART (odds ratio=0.77, P=0.02). There was no survival benefit (HR=0.97; P=0.89). With ART compared with WS, there was significantly increased toxicity of any grade (50% vs. 38.6%), grade 2 or greater GU toxicity (17.1% vs. 10.3%), grade 2 or greater GI toxicity (2.5% vs. 1.1%), urinary stricture rates (11.1% vs. 5.7%) and, urinary incontinence (6.9% vs. 2.7%).
Ten-year metastasis-free survival is significantly improved with ART compared with WS. Biochemical progression-free, clinical progression-free, and hormone-free survival were also improved with ART. Grade 2 or higher GI and GU toxicities were greater in ART. Therefore, ART should be offered to patients with these high-risk features.
*Department of Radiation Oncology, Stritch School of Medicine
†Research Methodology, School of Education, Loyola University-Chicago, Chicago, IL
M.P.S., F.A., M.-J.W., A.A.S., and M.M.H.: contributed to: (1) substantial contributions to conception or design of the work, or the acquisition, analysis, or interpretation of data for the work; (2) drafting of the work or revising it critically for important intellectual content; (3) final approval of the version to be published; and (4) agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
The authors declare no conflicts of interest.
Reprints: M. Parvez Shaikh, MD, Department of Radiation Oncology, Loyola University Medical Center, 2160 South 1st Ave, Maguire Center, Rm 2944, Maywood, Chicago, IL 60153. E-mail: email@example.com.