Title: Bicalutamide in the treatment of advanced prostatic carcinoma: a phase II multicenter trial.
Title Abreviation: Urology Date of Pub: 1996 Jan
Author: Soloway MS; Schellhammer PF; Smith JA; Chodak GW; Kennealey GT;
Issue/Part/Supplement: 1A Suppl Volume Issue: 47 Pagination: 33-7; discussion 48-53
MESH Headings: Acid Phosphatase (BL); Adult; Aged; Aged, 80 and over; Androgen Antagonists (*TU); Anilides (*TU); Human; Male; Middle Age; Prostate; Prostate-Specific Antigen (BL); Prostatic Neoplasms (BL/*DT); Support, Non-U.S. Gov't; -RN-;
Journal Title Code: WSY Publication Type: CLINICAL TRIAL
Date of Entry: 960226N Entry Month: 9605
Country: UNITED STATES Index Priority: 2
Language: Eng Unique Identifier: 96149764
Unique Identifier: 96149764 ISSN: 0090-4295
Abstract: OBJECTIVES. The safety, efficacy, and pharmacokinetics of the nonsteroidal antiandrogen bicalutamide were investigated in a Phase II trial in 150 patients with metastatic prostate cancer. METHODS. Patients took bicalutamide, 50 mg daily, in an open-label multicenter North American trial. RESULTS. The objective response rate (modified European Organization on Research and Treatment of Cancer [EORTC] criteria) was 70% (57% partial, 13% stable); 59 (39%) of 150 patients had either a > 90% decrease in prostate-specific antigen (PSA) levels or a decline to < 4 ng/mL. Extent of disease on the bone scan was a significant predictor of response. Patients with < 6 metastatic lesions were more likely to respond. Breast pain and gynecomastia occurred in 76% and 60% of patients, respectively. Gastrointestinal toxicity was very infrequent (diarrhea, 5%) The mean drug plasma concentration was 8528 (+/- 2928) ng/mL. CONCLUSIONS. Bicalutamide, 50 mg daily, was well tolerated and has efficacy in metastatic prostate cancer. The percentage of men who had > 90% decline in PSA levels is less than observed with surgical or medical castration and has led to trials using this antiandrogen at higher doses as monotherapy.
Abstract By: Author
Address: Department of Urology, University of Miami School of Medicine, FL 33101, USA.

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