Androgen Suppression and Radiation vs Radiation Alone for Prostate Cancer

TLDR

The study compared 6 months of androgen suppression therapy plus radiation therapy to radiation therapy alone in men with localized but unfavorable‑risk prostate cancer, evaluating how comorbidity level influenced all‑cause mortality. A randomized trial of 206 men enrolled at academic and community centers, using the Adult Comorbidity Evaluation 27 score and log‑rank analysis, followed patients for a median of 7.6 years to compare mortality between treatment groups. Overall, men receiving radiation alone had a 1.8‑fold higher all‑cause mortality than those receiving radiation plus androgen suppression, but this excess risk was confined to patients with no or minimal comorbidity, while those with moderate or severe comorbidity showed no significant difference.

Abstract

Comorbidities may increase the negative effects of specific anticancer treatments such as androgen suppression therapy (AST).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.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.Time to all-cause mortality.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).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.clinicaltrials.gov Identifier: NCT00116220.