CLINICAL PILOT-STUDY OF INTRAHEPATIC ARTERIAL CHEMOTHERAPY WITH METHOTREXATE, 5-FLUOROURACIL, CISPLATIN AND SUBCUTANEOUS INTERFERON-ALPHA-2B FOR PATIENTS WITH LOCALLY ADVANCED HEPATOCELLULAR-CARCINOMA

To evaluate the efficacy of methotrexate (MTX)-5-fluorouracil (5-FU), cisplatin (CDDP), and interferon-alpha-2b(IFN alpha-2b) combination th erapy, we conducted a clinical pilot study in patients with locally ad vanced hepatocellular carcinoma (HCC). Sixteen patients, who had recei ved no prior treatment for the HCC, with portal tumor thrombosis in th e main trunk or in the major branch were enrolled in tile study. IFN a lpha-2b (3 x 10(6) units) was injected subcutaneously 3 times per week . After a bolus administration of MTX (30 mg/m(2)), CDDP (75 mg/m(2)) and thereafter 5-FU (750 mg/m(2)) were given weekly by intrahepatic ar terial infusion. In 15 eligible patients, there were 1 complete respon se (CR) and 6 partial responses (PR) with a response rate of 46.7%. Me dian survival of the 15 patients was 7 months, and the 2-year survival rate of CR and PR patients was 57.1%. There was severe transient hema tologic toxicity. More than grade 2 nausea/vomiting was noted in >50%. In conclusion, the IFN alpha-2b combination chemotherapy demonstrated good response in patients with locally advanced HCC. This treatment s hould be tried in a controlled study.