EVALUATION OF ANTIANDROGEN THERAPY IN UNRESECTABLE HEPATOCELLULAR-CARCINOMA - RESULTS OF A EUROPEAN ORGANIZATION FOR RESEARCH AND TREATMENTOF CANCER MULTICENTRIC DOUBLE-BLIND TRIAL

Purpose: The aim of the study was to evaluate the efficacy of antiandr ogen therapy on overall survival and response in unresectable hepatoce llular carcinoma (HCC). Patients and Methods: A total of 244 patients with unresectable HCC were included in this multicentric double-blind trial. According to a two-by-two factorial design, patients were rando mly assigned to receive one of the following treatments: pure antiandr ogen plus placebo (A+P group, 60 patients); luteinizing hormone-releas ing hormone (LHRH) agonist plus placebo (LHRH+P group, 62 patients); p ure antiandrogen plus LHRH agonist (A+LHRH group, 62 patients); or pla cebo plus placebo (P+P group, 60 patients). Pure antiandrogen consiste d of Anandron (Roussel-Uclaf Laboratory, Romainville, France) administ ered orally (300 mg daily for 1 month, then 150 mg daily). LHRH consis ted of goseriline acetate (3.6 mg) or triptoreline (3.75 mg) administe red monthly by subcutaneous injection. Treatment was given until death . Response was evaluated every 8 weeks according to World Health Organ ization (WHO) criteria. Results: Six patients were considered ineligib le. One patient had a complete response (A+P arm) and three had a part ial response (two in the LHRH+P arm and one in the A+LHRH arm). An ove rall log-rank test did not demonstrate any significant difference in s urvival among the four arms. taking the factorial design into account, comparison of survival showed no significant difference between Anand ron containing regimens and others, or between LHRH-containing regimen s and others. No serious side effects occurred for any regimen. Conclu sion: This controlled study shows clearly the lack of efficacy of andr ogen treatment in unresectable HCC. (C) 1998 by American Society of Cl inical Oncology.