Bicalutamide in the treatment of advanced prostatic carcinoma: A phase II multicenter trial

Mark S. Soloway, Paul F. Schellhammer, Joseph A. Smith, Gerald W. Chodak, Gerard T. Kennealey

Research output: Contribution to journalArticlepeer-review

22 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)33-37
Number of pages5
Issue number1 SUPPL. 1
StatePublished - Jan 1 1996

ASJC Scopus subject areas

  • Urology


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