Phase II intravenous study of epirubicin with 5-fluorouracil in patients with advanced hepatocellular carcinoma

Between August 1986 and September 1990, 22 previously untreated non-cirrhotic patients with measurable unresectable primary liver cancer were treated every 4 weeks with a combination of epirubicin and 5-fluorouracil. The dose of epirubicin was escalated; the starting dose was 40 mg/m², the second dose was 50 mg/m² and thereafter 60 mg/m² during subsequent cycles. The dose of 5-fluorouracil was always 800 mg/m². Objective response rate was 14%. Most of the patients experienced only mild haematological toxicity, and no other dose limiting toxicity was observed. Nonetheless, increasing the dose would probably not have increased the response rate.