Hairloss Study Abstract: A controlled trial of bicalutamide versus flutamide

Title: A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group.
Title Abreviation: Urology		Date of Pub: 1995 May
Author: Schellhammer P; Sharifi R; Block N; Soloway M; Venner P; Patterson AL; Sarosdy M; Vogelzang N; Jones J; Kolvenbag G;
Issue/Part/Supplement: 5	Volume Issue: 45		Pagination: 745-52
MESH Headings: Adenocarcinoma (BL/DT/MO/PA); Adult; Aged; Aged, 80 and over; Anilides (AD/AE); Antineoplastic Agents (AD/AE); Antineoplastic Agents, Combined (AE/TU); Comparative Study; Confidence Intervals; Double-Blind Method; Flutamide (AD/AE); Follow-Up Studies; Goserelin (AD/AE); Human; Leuprolide (AD/AE); Male; Middle Age; Proportional Hazards Models; Prospective Studies; Prostate-Specific Antigen (BL/DE); Prostatic Neoplasms (BL/*DT/MO/PA); Regression Analysis; Support, Non-U.S. Gov't; Survival Rate; Treatment Failure; -RN-;
Journal Title Code: WSY	Publication Type: CLINICAL TRIAL
Date of Entry: 950612N	Entry Month: 9508
Country: UNITED STATES	Index Priority: 2
Language: Eng	Unique Identifier: 95266189
Unique Identifier: 95266189	ISSN: 0090-4295
Abstract: OBJECTIVES. To compare the efficacy and safety of bicalutamide and flutamide, each used in combination with luteinizing hormone-releasing analogue (LHRH-A) therapy, in patients with untreated metastatic (Stage D2) prostate cancer. METHODS. Randomized, double-blind (for antiandrogen therapy), multicenter study with a 2 x 2 factorial design. Eight hundred thirteen patients were allocated 1:1 to bicalutamide (50 mg once daily) and flutamide (250 mg three times daily) and 2:1 to goserelin acetate (3.6 mg every 28 days) and leuprolide acetate (7.5 mg every 28 days). RESULTS. With a median duration of follow-up of 49 weeks, time to treatment failure, the primary endpoint, was significantly (P = 0.005) better for the bicalutamide plus LHRH-A group than for the flutamide plus LHRH-A group. Patients in the flutamide plus LHRH-A group were 34% more likely to fail treatment over the given time period, as indicated by the hazard ratio of 0.749 (95% confidence interval, 0.61 to 0.92) for bicalutamide plus LHRH-A to flutamide plus LHRH-A. Results for secondary endpoints (survival, quality of life, and subjective response) were similar between groups. Diarrhea occurred in 24% of patients in the flutamide plus LHRH-A group, compared with 10% of patients in the bicalutamide plus LHRH-A group (P < 0.001). CONCLUSIONS. In patients with metastatic prostate cancer, bicalutamide plus LHRH-A is well tolerated and provides superior efficacy to flutamide plus LHRH-A with respect to time to treatment failure. Assessment of the effects of these regimens on longer term survival requires additional time for follow-up.
Abstract By: Author
Address: Eastern Virginia Medical School, Norfolk, USA.