Phase II study of combined administration of 5-fluorouracil, epirubicin and mitomycin-C by hepatic artery infusion in patients with liver metastases of gastric cancer.

This multicenter phase II study evaluated the efficacy of the FEM regimen (5-fluorouracil 333 mg/m(2) each week, epirubicin 30 mg/m(2) once every 4 weeks and mitomycin-C 2.7 mg/m(2) once every 2 weeks) administered by hepatic artery infusion (HAI) for unresectable hepatic metastases of gastric cancer. The response rates were 55.6% (complete response: 3, partial response: 32, no change: 21, progressive disease: 7/63) and the mean 50% survival was 10.5 months. Most responders died due to the progression of extrahepatic lesions. HAI of the FEM regimen induced a high response rate in patients with hepatic metastases of gastric cancer, and the prognosis-determining factor was the existence of extrahepatic lesions in many patients.