Survival of patients who had salvage castration after failure on bicalutamide monotherapy for stage (D-2) prostate cancer

Patients with hormone-naive stage D-2 prostate cancer often benefit from ca stration. This treatment, however, frequently produces many unacceptable ph ysical and psychological side effects, especially in younger and sexually a ctive patients. Bicalutamide is an oral antiandrogen with excellent toleran ce and preservation of sexual function. Three institutions participated in phase II and III trials of bicalutamide monotherapy (50 mg daily) as primar y therapy in hormone-naive patients with stage D-2 prostate cancer. Upon bi calutamide failure, all patients underwent castration and were followed unt il death. Fifty-four patients received bicalutamide 50 mg orally once a day . One patient (2%) had complete response, 9 patients (17%) had partial resp onse, and 27 patients (50%) had stable disease. Seventeen patients (31%) ha d progressive disease. The median time to bicalutamide failure was 47.4 wee ks, 70.5 weeks for the responders vs. 25.4 weeks for the nonresponders (p < 0.001). The median survival time after the sequential use of bicalutamide and castration was 119.2 weeks for all 54 patients, 162.0 weeks for the res ponders, and 73.5 weeks for nonresponders (p < 0.0001). The median survival time after initiation of castration was 71.1 weeks for all 54 patients, 91 .4 weeks for bicalutamide responders, and 42.1 weeks for nonresponders (p < 0.01). In hormone-naive patients with stage D-2 prostate cancer, sequentia l treatment with bicalutamide monotherapy followed by castration upon failu re may produce survival time within the range reported for initial treatmen t with castration. Thus, considering the favorable quality of life profile of bicalutamide, further studies are needed to define the role of sequentia l hormonal therapy in younger sexually active patients.