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- Title
Combined androgen blockade with bicalutamide for advanced prostate cancer: long-term follow-up of a phase 3, double-blind, randomized study for survival.
- Authors
Akaza H; Hinotsu S; Usami M; Arai Y; Kanetake H; Naito S; Hirao Y; Study Group for the Combined Androgen Blockade Therapy of Prostate Cancer; Akaza, Hideyuki; Hinotsu, Shiro; Usami, Michiyuki; Arai, Yoichi; Kanetake, Hiroshi; Naito, Seiji; Hirao, Yoshihiko
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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<or=1 ng/mL was a prognostic factor for improved survival. More patients attained PSA nadir concentrations<or=1 ng/mL with CAB compared with patients who received LHRH-A monotherapy (81.4% vs 33.7%; P<.001).<bold>Conclusions: </bold>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.
- Publication
Cancer (0008543X), 2009, Vol 115, Issue 15, p3437
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/cncr.24395