Analysis of results of bicalutamide monotherapy versus castration in patients with non-metastatic locally advanced prostate cancer during 6.3-year follow-up

Objective. Monotherapy with nonsteroid antiandrogens may be used in a number of patients with advanced prostate cancer (PC). We present the results of analysis of survival and safety of treatment in patients with nonmetastatic (M0) locally advanced PC treated with bicalutamide, 150 mg, or castrated in two studies.
Materials and methods: These were pooled data of two open-labeled multicenter studies of the identical design. The patients with PC (T3— 4) were randomized to treatment with bicalutamide, 150 mg/day or castration (bilateral orchiectomy or goserelin acetate, 3.6 mg, once every 28 days) in a ratio of 2:1.
Results: 480 patients with locally advanced PC were randomized. During a median follow-up of 6.3 years, mortality was 56%. There were significant differences in overall survival (relative risk 1.05; the upper 95% CI 1.31; p=0.70) and in interval before progression (1.20; 1.45; p=0.11) between both groups. Bicalutamide therapy was ascertained to have an advantage in two life quality indices: sexual function (p=0.029) and physical capacities (p=0.046). The most common adverse reactions were hot flushes in the castration group and breast pain and gynecomastia in the bicalutamide group. The frequency of other side effects of the therapy was low. Bicalutamide was well tolerated. The drug used during the study had to be discontinued due to adverse reactions only in several cases. There were no new problems associated with the safety of bicalutamide therapy during a long-term follow-up.
Conclusion: Monotherapy with bicalutamide in a dose of 150 mg is an attractive alternative to castration in patients with locally advanced PC in whom hormonal treatment is indicated.