Randomized clinical trial of chemoembolization plus radiofrequency ablation versus partial hepatectomy for hepatocellular carcinoma within the Milan criteria.

Abstract

This study aimed to compare sequential treatment by transcatheter arterial chemoembolization (TACE) and percutaneous radiofrequency ablation (RFA) with partial hepatectomy for hepatocellular carcinoma (HCC) within the Milan criteria. In a randomized clinical trial, patients with HCC within the Milan criteria were included and randomized 1 : 1 to the partial hepatectomy group or the TACE + RFA group. The primary outcome was overall survival and the secondary outcome was recurrence-free survival. Two hundred patients were enrolled. The 1-, 3- and 5-year overall survival rates were 97·0, 83·7 and 61·9 per cent for the partial hepatectomy group, and 96·0, 67·2 and 45·7 per cent for the TACE + RFA group (P = 0·007). The 1-, 3- and 5-year recurrence-free survival rates were 94·0, 68·2 and 48·4 per cent, and 83·0, 44·9 and 35·5 per cent respectively (P = 0·026). On Cox proportional hazard regression analysis, HBV-DNA (hazard ratio (HR) 1·76; P = 0·006), platelet count (HR 1·00; P = 0·017) and tumour size (HR 1·90; P < 0·001) were independent prognostic factors for recurrence-free survival, and HBV-DNA (HR 1·61; P = 0·036) was a risk factor for overall survival. The incidence of complications in the partial hepatectomy group was higher than in the TACE + RFA group (23·0 versus 11·0 per cent respectively; P = 0·024). For patients with HCC within the Milan criteria, partial hepatectomy was associated with better overall and recurrence-free survival than sequential treatment with TACE and RFA. ACTRN12611000770965 (http://www.anzctr.org.au/).