Objective : To retrospectively investigate the safety and efficacy of sorafenib combined with transarterial chemoembolization (TACE) plus radiofrequency ablation (RFA) in the treatment of recurrent hepatocellular carcinoma with portal vein tumor thrombosis and/or extrahepatic metastases (advanced rHCC) after initial hepatectomy.
Methods : The study was centrally approved by the ethics committee of three tertiary medical centers in China. From January 2010 to January 2015, 207 consecutive patients with advanced rHCC after initial hepatectomy were treated with sorafenib combined with TACE-RFA (combination group, n = 106) or sorafenib alone (sorafenib group, n = 101) in the three medical centers. Overall survival (OS) and time to progression (TTP) were compared between these two groups. Complications were assessed. The survival curves were constructed by the Kaplan-Meier method and compared by the log-rank test.
Results : The baseline characteristics were balanced between the two groups. No treatment-related death occurred in both groups. The toxicity profile of combination group was similar to that of sorafenib group. After treatment, the median OS (14.0 months vs 9.0 months, p<0.001) and TTP (7.0 months vs 4.0 months, p<0.001) in the combination group were significantly longer than those in the sorafenib group. Multivariate analysis showed that treatment allocation was the significant predictor of OS and TTP while the number of intrahepatic tumor was another prognostic factor of OS.
Conclusions : Sorafenib combined with TACE-RFA was well tolerated and safe, and superior to sorafenib alone in improving survival outcomes for patients with advanced rHCC after initial hepatectomy.