Transarterial ethanol ablation of hepatocellular carcinoma with lipiodol ethanol mixture: phase II study.

PURPOSE: This prospective trial aimed to evaluate the safety and effectiveness of transarterial ethanol ablation (TEA) of intrahepatic lesions of hepatocellular carcinoma (HCC) with a Lipiodol-ethanol mixture. MATERIALS AND METHODS: Seventy-seven patients were recruited and 164 lesions (mean size, 5.2 cm +/- 3.0) were treated. Inclusion criteria included histologic proof of HCC, refusal of (n = 9) or contraindication to (n = 68) surgical resection, Eastern Cooperative Oncology Group performance status no greater than 2, and intrahepatic disease without vascular invasion. The mixture consisted of 33% ethanol by volume, with the total dose of Lipiodol-ethanol mixture limited to 60 mL for each treatment session. The primary endpoint was patient survival. Secondary endpoints were tumor response, adverse effects of treatment, and progression-free survival. Median follow-up time for the whole cohort was 2.3 years. RESULTS: Median overall survival was 2.2 years. Overall survival and progression-free survival rates at 1 year and 2 years were 77.9% and 50.1% and 63.6% and 46.3%, respectively. Complete ablation according to radiologic criteria was achieved in 61 patients (79.2%) and 86% of the 164 treated lesions. Mean tumor volume reduction was 65.22%. Patient survival was significantly better in patients with tumors no larger than 5 cm (Cox proportional-hazards regression, P = .0074). Treatment response was significantly better for patients with tumors no greater than 7 cm (chi2 test, P = .0462; Fisher exact test, P = .0326). Adverse effects included irreversible hepatic decompensation (0.6% of procedures), pain (4.8%), and fever (13.8%). CONCLUSIONS: TEA is a safe and effective means to establish local control of unresectable and resectable intrahepatic lesions of HCC.