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Japanese Journal of Clinical Oncology, Vol 29, Issue 11 562-570, Copyright © 1999 by Foundation for Promotion of Cancer Research

CASE REPORTS

Goserelin acetate with or without antiandrogen or estrogen in the treatment of patients with advanced prostate cancer: a multicenter, randomized, controlled trial in Japan. Zoladex Study Group

T Kotake, M Usami, H Akaza, K Koiso, Y Homma, K Kawabe, Y Aso, S Orikasa, J Shimazaki, S Isaka, O Yoshida, Y Hirao, E Okajima, S Naito, J Kumazawa, H Kanetake, Y Saito, Y Ohi and Y Ohashi
Osaka Medical Center for Cancer and Cardiovascular Diseases, Japan.

OBJECTIVE: The aims of this randomized, controlled study were to investigate the efficacy and safety of long-term monotherapy with the luteinizing hormone-releasing hormone agonist goserelin acetate compared with both short- and long-term combined androgen blockade. METHODS: Patients with advanced prostate cancer (n = 371) were randomized to treatment with goserelin acetate alone or a combination of goserelin acetate plus either long-term or short-term antiandrogen (chlormadinone acetate) or short-term estrogen (diethylstilbestrol diphosphate). RESULTS: There were no significant differences between the treatment groups with respect to objective progression, overall survival or disease-specific survival. Nevertheless, subgroup analysis suggested that patients with minimal disease or a good prognosis might benefit more from combined androgen blockade than other patients. Combined androgen blockade significantly reduced the incidence of disease flare compared with goserelin acetate treatment alone. CONCLUSIONS: Neither short- nor long-term combined androgen blockade had a survival advantage over goserelin acetate alone.
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