Adjuvant TACE improves disease-free survival in HCC with no vascular invasion after hepatectomy – Result of randomized controlled trial

Abstract

Introduction: Hepatectomy is the mainstay of curative treatment for hepatocellular carcinoma (HCC) with a recurrence rate ranging from 46 to 72 % in 3 years. There has been no consensus on the use of adjuvant transarterial chemoembolization (TACE) for HCC after hepatectomy. This study aimed to demonstrate that TACE using cisplatin-lipiodol mixture and gelatin sponge particle embolization could improve disease-free survival in HCC patients after curative hepatectomy. Method: A single-centre, open label, randomized controlled trial of adjuvant TACE performed 4 to 6 weeks after curative hepatectomy compared to hepatectomy alone (control arm) was performed. Primary outcome was 1-year recurrence rate. Secondary outcomes were disease-free and overall survival. Chi-square test was used for categorical variables. Survival was analysed by log-rank test using Kaplan-meier method. Result: From Dec 2011 to Aug 2016, 58 cases were recruited and randomized. 2 patients were excluded after randomization due to consent withdrawal and clinically not fit for TACE. 27 patients were randomized to adjuvant TACE arm. 29 patients were randomized to control arm. There was no significant difference (p-value = 0.672) in 1-year recurrence rates between TACE (26%) and control arm (31%). There was a trend towards longer mean disease-free survival in TACE arm (57.8 vs 42.6 months), but not reaching statistical significance (p-value = 0.094). In subgroup analysis, use of adjuvant TACE in patients with T1 and T2 tumor without vascular invasion was associated with significant (p=0.003) longer mean disease-free survival (66.6 vs 40.1 months). No significant difference (p-value = 0.513) was observed in disease-free survival in the subgroup with vascular invasion. Conclusion: Use of adjuvant TACE in T1 and T2 HCC without vascular invasion after curative hepatectomy showed better disease-free survival.