Combined androgen blockade with bicalutamide for advanced prostate cancer

BACKGROUND: A previously reported, double‐blind, randomized, multicenter phase 3 trial in 205 patients with stage C/D prostate cancer compared combined androgen blockade (CAB) with luteinizing hormone‐releasing hormone agonist (LHRH‐A) plus bicalutamide 80 mg versus LHRH‐A plus bicalutamide‐matching placebo (LHRH‐A monotherapy). The analysis at a median follow‐up of 2.4 years indicated that CAB significantly ( P < .001) prolonged the time to progression and the time to treatment failure. In the current report, survival data from a long‐term follow‐up (median, 5.2 years) were analyzed. METHODS: All deaths irrespective of cause and all prostate cancer‐specific deaths were recorded. The data were analyzed using Cox regression analysis and the log‐rank test. RESULTS: At a median follow‐up of 5.2 years, a significant overall survival advantage was observed in favor of CAB over LHRH‐A monotherapy (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 2 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 ng/mL with CAB compared with patients who received LHRH‐A monotherapy (81.4% vs 33.7%; P < .001). CONCLUSIONS: CAB with bicalutamide 80 mg offered a significant overall survival benefit compared with LHRH‐A monotherapy without reducing tolerability in patients with locally advanced or metastatic prostate cancer. Cancer 2009. © 2009 American Cancer Society.