Controlled clinical trial of doxorubicin and tamoxifen versus tamoxifen monotherapy in hepatocellular carcinoma

OBJECTIVES METHODSThirty-two consecutive patients with a priori defined contra-indications against surgery (transplantation, resection) or chemo-embolization were evaluated to receive chemotherapy. All patients received oral tamoxifen 30 mg bid; 16 also received intravenous doxorubicin 50 mg/m every 4 weeks. The control group consisted of the remaining 16 patients who either were considered unfit for doxorubicin because of a Karnofsky index < 50% (n = 5), cardiac disease (n = 6) or who refused to have cytotoxic drug therapy (n = 5). RESULTSMedian survival time was 148 days (95% CI 89.2-206.8) in the doxorubicin group and 96 days (95% CI 49.0-143.0) in the control group, and this was not significantly different (P = 0.408), regardless of the presence or absence of cirrhosis. CONCLUSIONSIn conclusion, the results of our study indicate that combination therapy using doxorubicin and tamoxifen is unlikely to considerably improve survival compared to tamoxifen alone in patients with advanced hepatocellular carcinoma. Eur J Gastroenterol Hepatol 12:281-284 © 2000 Lippincott Williams & WilkinsEuropean Journal of Gastroenterology & Hepatology 2000, 12:281-284