Recombinant leukocyte interferon, doxorubicin, and 5FUDR in patients with hepatocellular carcinoma-A phase II trial

Purpose: To study the combination of 5FUDR, recombinant leukocyte interferon (IFN), and doxorubicin in patients with unresectable hepatocellular carcinoma. Methods: IFN was administered at a dose of 6 miu/m(2) subcutaneously followed in 2 h by doxorubicin 20 mg/m(2) intravenously. After doxorubicin, 5FUDR was given as a 24-h infusion at a starting dose of 80 mg/kg. The dose of IFN was escalated to three times a week if tolerated. Both doxorubicin and 5FUDR were administered once weekly. Results: There were 30 patients entered into the study. Among the 30 patients, there were two partial responses (7%) and one patient had stable disease. Toxicity was generally tolerable with fever, and chills, fatigue, and myelosuppression as the most common side effects. Conclusions: This chemotherapy combination was generally well tolerated, but has limited activity in unresectable, advanced hepatocellular carcinoma.