Background. Modest activity for doxorubicin has been detected repeatedly for the therapy of advanced hepatocellular carcinoma. Variable activity in this disease also has been documented for alpha-interferon. Preclinical data indicated the possibility that alpha-interferon could enhance or add to the cytotoxic effect of doxorubicin.
Methods. The authors evaluated the use of alpha-interferon at a dose of 12 × 106 units/m2/day for 5 days given by intramuscular injection plus doxorubicin 25–40 mg/m2 given intravenously on day 3 (both repeated every 4 weeks) for the treatment of advanced hepatocellular carcinoma.
Results. Among 31 eligible patients treated, there was only one instance of objective tumor regression. The median survival for all patients was 10 months. Both hematologic and nonhematologic toxicity were significant but tolerable to the patients.
Conclusions. The 3% response rate indicated that, by the method used, the addition of alpha-interferon to doxorubicin does not improve the clinical effectiveness. This combination cannot be recommended for further study.