Purpose: The safety, efficacy and pharmacokinetics of bicalutamide were investigated in 150 patients with stage D2 prostate cancer. Materials and Methods: Patients received 50 mg. bicalutamide daily in an open label multicenter North American trial. Results: The objective response rate (modified European Organization for Research in Cancer Therapy criteria) was 70 percent. Of 150 patients 59 (39 percent) met prostate specific antigen criteria for partial response, and 88 (59 percent) reached treatment failure end points and withdrew. Extent of disease was a significant predictor of response but baseline testosterone was not. Breast pain and gynecomastia developed in 76 percent and 60 percent of patients, respectively. Mean drug plasma concentration was 8,528 plus/minus 2,928 ng./ml. Conclusions: Bicalutamide (50 mg.) daily was well tolerated and efficacious. However, suboptimal effects on prostate specific antigen have led to additional trials to evaluate monotherapy at higher doses.
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