EPIRUBICIN AND ETOPOSIDE COMBINATION CHEMOTHERAPY TO TREAT HEPATOCELLULAR-CARCINOMA PATIENTS - A PHASE-II STUDY

Approximately half the patients affected with hepatocellular carcinoma (HCC) present with unresectable disease, so that efficacious systemic chemotherapy protocols are badly needed. We report the results of a p hase-II study aimed at testing the efficacy and toxicity of a combinat ion of epirubicin and VP-16. Thirty six patients (30 men and 6 women) received epirubicin (40 mg/m(2), on day 1) and VP-16 (120 mg/m(2), on days 1, 3 and 5) every 28th day. Chemotherapy was stopped in case of d isease progression, while the patients who achieved an objective respo nse or who had stable disease continued treatment for a maximum of 10 cycles. One patient (3%) achieved a complete response, while 13 patien ts (36%) achieved partial response, i.e. 14 objective responses in all (39%, 95% CI: 23-55%). 11 patients (31%) exhibited stable disease, wh ile in the other 11 patients (31%) the disease progressed. Median over all survival time was 10 months and 13.5 months in the subgroup of pat ients responding to treatment. Significant, especially haematological, toxicity was documented, but in no case was it so severe as to requir e discontinuation of treatment or reduction of the dosage. In conclusi on, this combination appears to be an active and tolerable therapeutic option for HCC patients who are not candidates for surgical or locore gional procedures, and in our opinion it deserves further exploration within a randomised controlled trial versus best supportive therapy. ( C) 1997 Published by Elsevier Science Ltd.