UroToday.com - This study sought to compare survival in a prospective randomized trial of radiotherapy (XRT) alone vs. XRT with 6 months of ADT. 206 men were accrued and randomized. They all had at least one unfavorable-risk factor. 70 Gy of XRT was given. The lymph nodes were not treated. ADT was 2 months prior, during and 2 months after XRT. Salvage ADT was given for a PSA >10ng/ml. The study compliance was very high, but 29% had the antiandrogen held primarily due to hepatic or GI toxicity. The median PSA was 11ng/ml and 73% had Gleason 7 or higher. Thus it is a mix of intermediate and high-risk patients.
The PCSM difference was 10%, favoring combined therapy. Overall survival was favored by 13%. Most patients in the study had only mild comorbidity. A history of MI was the reason for moderate or severe comorbidity in 25%. At 8 years, there is a 26% overall survival benefit if the patient had only mild comorbidities. In moderate or severe comorbidities, there was a worse overall survival by 29% if they received XRT and ADT. This surprising result suggests that sicker patients had interaction of ADT with their existing comorbidities (such as coronary artery disease) to result in worse survival. He suggested that future studies should include a pre-treatment comorbidity randomization strategy.
Presented by A. V. D'Amico at the American Society of Clinical Oncology (ASCO) - 2008 Genitourinary Cancers Symposium - A Multidisciplinary Approach - February 14-16, 2008 San Francisco, California, USA
Reported by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS Professor & Chairman Department of Urology University of California, Davis, School of Medicine Sacramento, CA
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