Transcatheter hepatic arterial chemoembolization and sorafenib for hepatocellular carcinoma: a meta-analysis of randomized, double-blind controlled trials

// Jun Li 1, * , Wenhui Liu 1, * , Wenhua Zhu 2, * , Yinqiao Wu 1 and Benyan Wu 1 1 Department of Gastroenterology, Chinese PLA General Hospital, Beijing 100853, China 2 Department of Oncology, Chinese 309th Hospital of PLA, Beijing 100091, China * Co-first authors Correspondence to: Yinqiao Wu, email: Wuyinqiao100915@163.com Benyan Wu, email: benyanwu@vip.sina.com Keywords: randomized controlled trial, transcatheter hepatic arterial chemoembolization, hepatocellular carcinoma, disease progression, overall survival Received: November 04, 2016      Accepted: July 06, 2017      Published: July 18, 2017 ABSTRACT We performed a meta-analysis of transcatheter hepatic arterial chemoembolization (TACE) combined with sorafenib for hepatocellular carcinoma (HCC), which included 4 double-blind, randomized controlled trials (RCTs) that investigated the effects of TACE combined with sorafenib (experimental groups) on time to disease progression (TTP), overall survival (OS), and various sorafenib-related adverse events, compared to those in the placebo (control) groups. A total of 877 HCC cases from 14 countries, including China and the USA, were included in our meta-analysis. The TTP increased significantly in the experimental groups (hazard ration [HR]: 0.82; 95% CI: 0.69–0.97; p = 0.02), but OS did not improve significantly (HR: 0.97; 95% CI: 0.72–1.29; p = 0.82), compared with the control groups. The risks of hand and foot skin reactions (HFSR), rash, fatigue, and diarrhea were significantly greater in the experimental groups ( p 0.05). Among these, the risk of HFSR was highest (risk ratio [RR]: 5.93; 95% CI: 2.00–17.53; p = 0.001), and a subgroup analysis of studies that lacked significant heterogeneity in the HFSR data showed a higher risk of HFSR (RR: 10.96; 95% CI: 5.54–21.69; p < 0.05). In conclusion, although TACE plus sorafenib increases TTP, it does not improve OS. Therefore, the risk of the adverse events of TACE plus sorafenib should be considered as a potential therapeutic limitation.