Casodex (bicalutamide) 150-mg monotherapy compared with castration in patients with previously untreated nonmetastatic prostate cancer: results from two multicenter randomized trials at a median follow-up of 4 years

• Published in: Urology (Ridgewood, N.J.) N.J.), 1998-03, Vol.51 (3), p.389-396
• Main Authors: Iversen, Peter, Tyrrell, Chris J., Kaisary, Amir V., Anderson, John B., Baert, Luc, Tammela, Teuvo, Chamberlain, Michael, Carroll, Kevin, Gotting-Smith, Karen, Blackledge, George R.P.
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Androgen Antagonists - administration & dosage; Anilides - administration & dosage; Antineoplastic agents; Antineoplastic Agents, Hormonal - therapeutic use; Biological and medical sciences; Castration; Chemotherapy; Disease Progression; Double-Blind Method; Follow-Up Studies; Goserelin - therapeutic use; Humans; Male; Medical sciences; Middle Aged; Nitriles; Pharmacology. Drug treatments; Prostatic Neoplasms - mortality; Prostatic Neoplasms - pathology; Prostatic Neoplasms - therapy; Quality of Life; Survival Rate; Time Factors; Tosyl Compounds
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/S0090-4295(98)00004-1

Objectives. To compare the efficacy, tolerability, and quality of life benefits of bicalutamide (Casodex) 150-mg/day monotherapy and castration in previously untreated nonmetastatic (MO) advanced prostate cancer. Methods. A total of 480 patients with Stage T3/T4 nonmetastatic disease randomly received oral bicalutamide 150 mg/day or castration (either 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 analysis. Results. In the combined survival analysis, at median follow-up of 202 and 205 weeks in studies 306 and 307, respectively, with 31% of the cases resulting in death, bicalutamide 150-mg monotherapy was statistically 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 time to objective progression (HR = 0.58; P = 0.033) and treatment failure (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) favored castration. Bicalutamide therapy showed significant advantages over castration for both sexual interest ( P = 0.029) and physical capacity ( P = 0.046). Bicalutamide 150-mg monotherapy was well tolerated. Conclusions. Bicalutamide 150-mg monotherapy provides a similar survival outcome to castration in previously untreated patients with nonmetastatic advanced prostate cancer and confers statistically significant benefits over castration with respect to sexual interest and physical capacity.