Combined Androgen Blockade With Bicalutamide For Advanced Prostate Cancer: Phase 3 Long-term Survival Follow-up, Double-blind, Randomized Study

Main Category: Prostate / Prostate Cancer
Also Included In: Urology / Nephrology;  Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 10 Aug 2009 - 0:00 PDT

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UroToday.com - Use of an anti-androgen with castration for the treatment of prostate cancer (CaP) is referred to as combined androgen blockage (CAB). Use of CAB has been assessed in over 30 studies and a meta-analysis suggests that when non-steroidal anti-androgens are used there is a survival benefit with risk of death reduced by 8%. In the journal Cancer, Professor Hideyuki Akaza and collaborators report on a multicenter, double-blind, controlled trial comparing CAB using the anti-androgen bicalutamide (80mg, the licensed dose for Japan) vs. castration alone.

A total of 205 Japanese men with stage C/D CaP were recruited at 49 centers between 2000 and 2001. Randomized treatment was given in a double-blind manner until September 2002 when the code was broken for ethical reasons. Patients continued to receive treatment until November 2003 or until there was disease progression. In the LHRH monotherapy arm, patients experiencing disease progression could then have bicalutamide added to their regimen. The demographic and baseline characteristics of patients were similar between the 2 treatment arms.

At a median follow-up of 5.2years, there were fewer overall deaths with CAB than with LHRH-A monotherapy (26 vs. 38 deaths, respectively). This was a significant overall survival advantage in favor of CAB. The 5-year overall survival rate estimated by Kaplan-Meier method was 75.3% for CAB vs. 63.4% for LHRH-agonist monotherapy. Cause-specific deaths were 14 in the CAB groups and 22 in the LHRH-agonist group, which was not statistically significant. PSA nadir to <0.1ng/ml was reached in 81.4% of men on CAB and by 33.7% of men on LHRH-agonist therapy. A PSA nadir was strongly associated with overall survival.

Akaza H, Hinotsu S, Usami M, Arai Y, Kanetake H, Naito S, Hirao Y
Cancer. 2009 Jun 17. Epub ahead of print.
doi:10.1002/cncr.24395

Written by UroToday.com Contributing Editor Christopher P. Evans, MD, FACS

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