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

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  • H Liu
    Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
  • Z-G Wang
    Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
  • S-Y Fu
    Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
  • A-J Li
    Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
  • Z-Y Pan
    Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
  • W-P Zhou
    Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China
  • W-Y Lau
    Faculty of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China
  • M-C Wu
    Third Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University, Shanghai, China

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<jats:title>Abstract</jats:title> <jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>Results</jats:title> <jats:p>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 &lt; 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).</jats:p> </jats:sec> <jats:sec> <jats:title>Conclusion</jats:title> <jats:p>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. Registration number: ACTRN12611000770965 (http://www.anzctr.org.au/).</jats:p> </jats:sec>

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