Phase II Trial of Hepatic Arterial Infusion Chemotherapy Using Cisplatin and 5-Fluorouracil in Patients with Advanced Hepatocellular Carcinoma

We investigated the effect of hepatic artery infusion (HAI) chemotherapy on advanced hepatocellular carcinoma. Ten milligrams per hour of cisplatin for 1 h and subsequently 250mg/h for 5h of 5-fluorouracil were administered using a subcutaneously implanted vascular access device (an injection port) for 5 consecutive days followed by 2 days rest. One course consisted of repetition of the above dosage regimen for 4 weeks. We treated 77 patients with advanced hepatocellular carcinoma (HCC), excluding nodular-type tumors indicated for chemoembolization, percutaneous ethanol injection therapy, or hepatic resection. Vascular invasion was seen in 28 patients and distant metastasis was seen in 7 patients. Of patients with advanced HCC, 77% were at tumor stage IV. Ten patients (13%) had a complete response, 25 (32%) had a partial response, 30 (39%) exhibited no change, and 12 (16%) had progressive disease. The response rate was thus 46%. Estimated 1-year, 2-year, and 3-year survival by the Kaplan-Meier method in 77 patients was 56%, 28%, and 19%, respectively. According to a multivariate analysis, the effects of initial therapy (P > .0001) and the Child-Pugh grade (P = .0012) were significant prognostic factors. A survival benefit was noted in patients with portal vein invasion (1-year survival rate: 43%, 2- year survival rate: 24%) when compared with reported results, and HAI was considered to be the first choice for unresectable cases. Adverse reactions of patients were tolerable and included transient nausea, loss of appetite, and mild thrombocytopenia. In conclusion, HAI chemotherapy with the regimen described achieved favorable results, and is useful in treating patients with advanced HCC not indicating chemoembolization, hepatic resection, or ethanol injection therapy.