5-Fluorouracil and alpha-interferon in hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) is a major cause of mortality worldwide, and no effective systematic therapy currently exists. Recombinant alpha-interferon (IFN) has been suggested to have some antitumor efficacy in this illness, and synergism with 5-fluorouracil (5-FU) has been reported in several gastrointestinal malignancies. We therefore treated 10 patients with advanced HCC with combination therapy consisting of 5-FU 750/mg/m(2) weekly and IFN 9 X 10(6) units three times weekly. Toxicity was substantial in this cirrhotic population, and included mucositis as well as neurologic and hematologic side effects. There were no sustained antitumor responses. Median survival among this heavily pretreated population was 10 months. We were therefore unable to demonstrate any significant benefit to treatment with 5-FU and IFN in patients with HCC.