Journal of Clinical Oncology, Vol 16, 411-417, Copyright © 1998 by American Society of Clinical Oncology
Evaluation of antiandrogen therapy in unresectable hepatocellular carcinoma: results of a European Organization for Research and Treatment of Cancer multicentric double-blind trial
C Grimaldi, H Bleiberg, F Gay, M Messner, P Rougier, TC Kok, L Cirera, A Cervantes, J De Greve, B Paillot, M Buset, D Nitti, T Sahmoud, N Duez and J Wils
Hopital de Cimiez, Nice, France.
PURPOSE: The aim of the study was to evaluate the efficacy of antiandrogen
therapy on overall survival and response in unresectable hepatocellular
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 randomly assigned
to receive one of the following treatments: pure antiandrogen plus placebo
(A+P group, 60 patients); luteinizing hormone-releasing hormone (LHRH)
agonist plus placebo (LHRH+P group, 62 patients); pure antiandrogen plus
LHRH agonist (A+LHRH group, 62 patients); or placebo plus placebo (P+P
group, 60 patients). Pure antiandrogen consisted of Anandron (Roussel-Uclaf
Laboratory, Romainville, France) administered orally (300 mg daily for 1
month, then 150 mg daily). LHRH consisted of goseriline acetate (3.6 mg) or
triptoreline (3.75 mg) administered monthly by subcutaneous injection.
Treatment was given until death. Response was evaluated every 8 weeks
according to World Health Organization (WHO) criteria. RESULTS: Six
patients were considered ineligible. One patient had a complete response
(A+P arm) and three had a partial response (two in the LHRH+P arm and one
in the A+LHRH arm). An overall log-rank test did not demonstrate any
significant difference in survival among the four arms. Taking the
factorial design into account, comparison of survival showed no significant
difference between Anandron-containing regimens and others, or between
LHRH-containing regimens and others. No serious side effects occurred for
any regimen. CONCLUSION: This controlled study shows clearly the lack of
efficacy of androgen treatment in unresectable HCC.
