Bicalutamide monotherapy versus flutamide plus goserelin in prostate cancer patients: Results of an Italian Prostate Cancer Project study

Purpose: To compare the efficacy of bicalutamide monotherapy to maximal and rogen blockade (MAB) in the treatment of advanced prostatic cancer. Patients and Methods: Previously untreated patients with histologically pro ven stage C or D disease (American Urological Association Staging System) w ere randomly allocated to receive either bicalutamide or MAB. After disease progression, patients treated with bicalutamide were assigned to castratio n. The primary end point for this trial was overall survival. Secondary end points included response to treatment, disease progression, treatment safe ty, quality-of-life (QOL), and sexual function. Results: A total of 108 patients received bicalutamide and 112 received MAB . There was no difference in the percentage of patients whose prostate-spec ific antigen returned to normal levels. At the time of the present analysis (median follow-up time, 38 months; range, 1 to 60 months), 129 patients pr ogressed and 89 died. There was no difference in the duration of either pro gression-free survival or overall survival. However, a survival trend favor ed bicalutamide in stage C disease but MAB in stage D disease. Overall and subgroup trends were confirmed by multivariate analysis. Serious adverse ev ents and treatment discontinuations were more common in patients receiving MAB (P = .08 and P = .04, respectively). Fewer patients in the bicalutamide group complained of lass of libido (P = .01)and of erectile dysfunction (P = .002). Significant trends favored bicalutamide-treated patients also wit h respect to their QOL, namely relative to social functioning, vitality, em otional well-being, and physical capacity Conclusion: Bicalutamide monotherapy yielded comparable results relative to standard treatment with MAB, induced fewer ride effects, and produced a be tter QOL. (C) 1999 by American Society of Clinical Oncology.