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

Background: 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. Methods: 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. Results: 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). Conclusion: 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.