456 A randomized double-blind trial in 813 previously untreated metastatic prostate cancer (CaP) patients (PTS) comparing a new antiandrogen casodex ® (bicalutamide) with eulexin (flutamide) in combination with luteinizing hormone releasing hormone analogue (LHRH-a) therapy

Abstract

Pts (813) with stage D2 CaP were randomized between Jan 92 and Sept 93, to CASODEX (C), 50 mg once daily or EULEXIN (E), 250 mg tid, given as double blind therapy each in combination with LHRH-a, either goserelin acetate (ZOLADEX ® ) or leuprolide acetate (LUPRON). PSA responses were similar in both treatment groups: the median percentage fall was 99% after 3 months of therapy, at which time 70% of the pts had a PSA value within the normal range (0–4 ng/ml). Of the 404 pts randomized to C-LHRH-a therapy, 168 (42%)have reached a treatment failure end point, while of the 409 pts randomized to E-LHRH-a therapy, 218 (53%) have reached treatment failure. The hazard ratio with regard to time to treatment failure of C-LHRH-a to E-LHRH-a was 0.749 (95% confidence interval, 0.61 to 0.92), indicating a significant advantage ( P = 0.005) for CASODEX-LHRH-a therapy. Hot flashes were the most frequent adverse event (C-LHRH-a: 49%, E-LHRH-a: 50%). The incidence of diarrhea was significantly higher for E-LHRH-a than for C-LHRH-a (24% vs. 10%; P