Androgen suppression and radiation vs radiation alone for prostate cancer - A randomized trial

Context Comorbidities may increase the negative effects of specific anticancer treatments such as androgen suppression therapy ( AST). Objectives To compare 6 months of AST and radiation therapy ( RT) to RT alone and to assess the interaction between level of comorbidity and all- cause mortality. Design, Setting, and Patients At academic and community- based medical centers in Massachusetts, between December 1, 1995, and April 15, 2001, 206 men with localized but unfavorable- risk prostate cancer were randomized to receive RT alone or RT and AST combined. All- cause mortality estimates stratified by randomized treatment group and further stratified in a postrandomization analysis by the Adult Comorbidity Evaluation 27 comorbidity score were compared using a log- rank test. Main Outcome Measure Time to all- cause mortality. Results As of January 15, 2007, with a median follow- up of 7.6 ( range, 0.5- 11.0) years, 74 deaths have occurred. A significant increase in the risk of all- cause mortality ( 44 vs 30 deaths; hazard ratio [ HR], 1.8; 95% confidence interval [ CI], 1.1- 2.9; P=. 01) was observed in men randomized to RT compared with RT and AST. However, the increased risk in all- cause mortality appeared to apply only to men randomized to RT with no or minimal comorbidity ( 31 vs 11 deaths; HR, 4.2; 95% CI, 2.1- 8.5; P <. 001). Among men with moderate or severe comorbidity, those randomized to RT alone vs RT and AST did not have an increased risk of all- cause mortality ( 13 vs 19 deaths; HR, 0.54; 95% CI, 0.27- 1.10; P=. 08). Conclusions The addition of 6 months of AST to RT resulted in increased overall survival in men with localized but unfavorable- risk prostate cancer. This result may pertain only to men without moderate or severe comorbidity, but this requires further assessment in a clinical trial specifically designed to assess this interaction. Trial Registration clinicaltrials. gov Identifier: NCT00116220