TREATMENT OF UNRESECTABLE HEPATOCELLULAR-CARCINOMA WITH A COMBINATIONOF HUMAN RECOMBINANT ALPHA-2B INTERFERON AND DOXORUBICIN - RESULTS OFA PILOT-STUDY

Based on the in vitro and in vivo potentiation of the cytotoxic activi ty of chemotherapeutic agents by the interferons, a pilot study combin ing human recombinant alpha-2b interferon (IFN) and doxorubicin was co nducted for the treatment of unresectable, histologically proven hepat ocellular carcinoma. Between March 1988 and May 1990, 21 patients (med ian age: 60 years, range: 29-76) entered the study. The dose of doxoru bicin was fixed at 35 mg/m(2), every 3 weeks. The dose of alpha-2b IFN was 6 million U/m(2) per day, 5 days a week. 3 patients (14%) obtaine d a partial response lasting 11, 16 and 30 months, and 1 had a stable disease during 8 months. The other 17 patients died within a median su rvival time of 4 months. All patients experienced flu-like symptoms. 7 patients experienced WHO grade III-IV haematological toxicity. We con clude that the association of alpha-2b IFN and doxorubicin is feasible , with respect to the use of doxorubicin at an inferior dose level tha n the same agent used without IFN. The response rate is comparable to that observed with doxorubicin used alone. Further phase I studies and randomised trials are required to confirm the role of this regimen in the treatment of unresectable hepatocellular carcinoma.