CASODEX (BICALUTAMIDE) 150-MG MONOTHERAPY COMPARED WITH CASTRATION INPATIENTS WITH PREVIOUSLY UNTREATED NONMETASTATIC PROSTATE-CANCER - RESULTS FROM 2 MULTICENTER RANDOMIZED TRIALS AT A MEDIAN FOLLOW-UP OF 4 YEARS

Objectives. To compare the efficacy, tolerability, and quality of life benefits of bicalutamide (Casodex) 150-mg/ day monotherapy and castra tion in previously untreated nonmetastatic (MO) advanced prostate canc er. Methods. A total of 480 patients with Stage T3/T4 nonmetastatic di sease randomly received oral bicalutamide 150 mg/day or castration (ei ther bilateral orchiectomy or goserelin acetate [Zoladex] 3.6 mg every 28 days) in a 2:1 ratio in two open multicenter studies (studies 306 and 307). The design of these studies was similar to allow a pooled an alysis. Results. In the combined survival analysis, at median follow-u p of 202 and 205 weeks in studies 306 and 307, respectively with 31% o f the cases resulting in death, bicalutamide 150-mg monotherapy was st atistically equivalent to castration; the risk of death from any cause was 7% less with bicalutamide than with castration (hazard ratio [HR] = 0.93). Data on time to treatment failure and objective progression could not be pooled, as results for these end points differed between the trials. In study 306, bicalutamide 150-mg monotherapy increased ti me to objective progression (HR = 0.58; P = 0.033) and treatment failu re (HR = 0.66; P = 0.074), whereas in study 307, time to progression ( HR = 1.35; P = 0.0471) and treatment failure (HR = 1.24; P = 0.097) fa vored castration. Bicalutamide therapy showed significant advantages o ver castration for both sexual interest (P = 0.029) and physical capac ity (P = 0.046). Bicalutamide 150-mg monotherapy was well tolerated. C onclusions. Bicalutamide 150-mg monotherapy provides a similar surviva l outcome to castration in previously untreated patients with nonmetas tatic advanced prostate cancer and confers statistically significant b enefits over castration with respect to sexual interest and physical c apacity. (C) 1998, Elsevier Science Inc. All rights reserved.