Combined androgen blockade with bicalutamide for advanced prostate cancer: Long-term follow-up of a phase 3, double-blind, randomized study for survival

Department of Urology, Institute of Clinical Medicine, University of Tsukuba, Ibaraki, Japan has released some very significant survival data about a previously reported, double-blind, randomized, multicenter phase 3 trial. This trial compared combined androgen blockade (CAB) with luteinizing hormone-releasing hormone agonist (LHRH-A) with the addition of bicalutamide (casodex) 80 mg (ADT2) to LHRH-A plus a placebo monotherapy (ADT1).

The trial studied 205 men with advanced prostate cancer, which in the original report the analysis at a median follow-up of 2.4 years indicated that CAB (ADT2) significantly (P < .001) prolonged the time to progression and the time to treatment failure. In the current data release the survival data from a long-term follow-up (median, 5.2 years) was analyzed and reported. All deaths irrespective of cause and all prostate cancer-specific deaths were noted. The data were analyzed using Cox regression analysis and the log-rank test. At a median follow-up of 5.2 years, a significant overall survival advantage was observed in favor of CAB (ADT2) over LHRH-A monotherapy (ADT1) (Cox regression analysis: hazard ratio, 0.78; 95% confidence interval, 0.60-0.99; P = .0498; log-rank test: P = .0425). The difference in cause-specific survival between the two groups was not significant. The achievement of a prostate-specific antigen (PSA) nadir concentration < /=1 ng/mL was a prognostic factor for improved survival. More patients attained PSA nadir concentrations < /=1 n