Tolerability assessment of maximal androgen blockade with 50 mg daily of bicalutamide and castration in patients with advanced prostate cancer

Background: Androgen is the most important growth factor for the development and growth of prostatic adenocarcinomas. For patients with advanced prostate cancer, hormonal manipulation including castration and antiandrogen therapy is a well-established mode of treatment. The choice of hormonal therapy for prostate cancer depends not only on the desired progression-free and overall survival, but also on the patient's quality of life, treatment costs, and treatment toxicities. Methods: This was an open, non-comparative trial to determine the tolerability of 50 mg bicalutamide (Casodex®) in combination with castration; we also investigated whether the prostate-specific antigen (PSA) rates of change at weeks 4 and 12 were indicative of an increased risk of progression. Results: Thirty-seven patients were enrolled in the study from December 1996 to June 1999 in Chang Gung Memorial Hospital, Taoyuan. The overall incidence rate of adverse events was 27%. The most frequent adverse event was hot flushes (5.4%). The rate of overall disease response was 85.3%. No evidence was found for any predictive relationship between serum PSA concentration and risk of progression. Conclusion: The overall results indicate that bicalutamide administered as a 50-mg daily dosage in combination with castration is a well-tolerated therapy for the treatment of patients with advanced prostate cancer.