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

Autor: Soloway MS; Department of Urology, University of Miami School of Medicine, FL 33101, USA., Schellhammer PF, Smith JA, Chodak GW, Kennealey GT
Jazyk: angličtina
Zdroj: Urology [Urology] 1996 Jan; Vol. 47 (1A Suppl), pp. 33-7; discussion 48-53.
DOI: 10.1016/s0090-4295(96)80006-9
Abstrakt: 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.
Databáze: MEDLINE
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