Abstract
OBJECTIVE: Transarterial chemoembolization (TACE) plus sorafenib has led to an increase in randomized controlled trials The efficacy and safety of sorafenib combined with TACE for the treatment of hepatocellular carcinoma (HCC) remain controversial. We conducted a comprehensive meta-analysis of randomized controlled trials on this issue. METHODS: A literature search was conducted by using online database: PubMed, the Cochrane Library, Embase, Web of Science, Chinese National Knowledge Infrastructure (CNKI) and Wan-fang, with no language restrictions. A Meta-analysis was performed to calculate the pooled odds ratio (OR) and its corresponding 95% confidence interval (CI) for the efficacy and safety of sorafenib combined with TACE in the treatment of HCC. Review Manager 5.4 software was used for data analysis. RESULTS: A total of 19 randomized controlled trials involving 2,029 patients met the inclusion criteria for this meta-analysis, including sorafenib combined with TACE group (n=1023) and TACE group (n=1006). The results of meta-analysis showed that sorafenib combined with TACE had a better prognosis in partial response rate (PR) [OR = 1.58,95%CI (1.30,1.92), P < 0.00001] with low heterogeneity among studies (P = 0.67; I2 = 0%) and the objective response rate (ORR) [OR = 1.93, 95%CI (1.59,2.34), P < 0.00001] with low heterogeneity among studies (P = 0.42; I2 = 3%). The 12-month overall survival (OS) was also significantly increased by combination therapy [OR = 3.18, 95%CI (2.41,4.19), P < 0.00001]. In terms of safety, the incidences were significantly high in TACE plus sorafenib group compared to TACE group for hand-foot skin reaction OR = 4.48, 95%CI (3.28,6.13), P < 0.00001 and for abdominal pain or diarrhea OR = 3.10, 95%CI (2.24,4.29), P = 0.04. However, no significant difference was found in nausea or vomit [OR = 1.14,95%CI (0.81,1.59), P = 0.68] or fever [OR = 0.87, 95%CI (0.61,1.23), P = 0.87]. CONCLUSION: The current comprehensive evidence suggests that sorafenib combined with TACE is more effective than TACE alone, especially for patients with intermediate-advanced and primary HCC.