Bicalutamide monotherapy compared with castration in patients with nonmetastatic locally advanced prostate cancer: 6.3 years of followup

Purpose: Nonsteroidal antiandrogen monotherapy may be a treatment option fo r some patients with advanced prostate cancer. We report a survival and saf ety update from an analysis of 2 studies in which patients with nonmetastat ic (M0) locally advanced disease were treated with either 150 mg, bicalutam ide monotherapy or castration. Materials and Methods: Data from 2 open label, multicenter studies of ident ical design were pooled according to protocol. Patients with stage T3/4 pro state cancer were randomized to receive 150 mg. bicalutamide daily or castr ation (orchiectomy or 3.6 mg. goserelin acetate every 28 days) in a 2:1 rat io. Results: A total of 480 patients with locally advanced prostate cancer were randomized to treatment. After a median followup of 6.3 years mortality wa s 56%. There was no statistically significant difference between the 2 grou ps in overall survival (hazard ratio 1.05, upper 1-sided 95% confidence lim it 1.31, p = 0.70) or time to progression (1.20, 1.45, p = 0.11). There wer e statistically significant benefits in the bicalutamide monotherapy group in the 2 quality of life parameters of sexual interest (p = 0.029) and phys ical capacity (p = 0.046). The highest incidences of adverse events were th e pharmacological side effects of hot flashes in the castration group, and breast pain and gynecomastia in the bicalutamide group. The incidences of o ther types of adverse events were low. Bicalutamide was well tolerated, wit h few drug related withdrawals from study, and no new safety issues were id entified during this longer followup. Conclusions: Monotherapy with 150 mg. bicalutamide is an attractive alterna tive to castration in patients with locally advanced prostate cancer for wh om immediate hormone therapy is indicated.