Purpose: Sorafenib combined with transcatheter arterial chemoembolization (TACE) is one of the common methods in the clinical treatment of advanced hepatocellular carcinoma (HCC), but its efficacy and safety are still controversial. Therefore, we used meta-analysis to evaluate the efficacy and safety of sorafenib combined with TACE in the treatment of advanced HCC.
Methods: Up to March 14, 2021, the databases of PubMed, EMBASE, Cochrane Library, CNKI and Wanfang were searched, and the randomized controlled clinical trials (RCTs) of sorafenib combined with TACE in the treatment of primary HCC were included. Two researchers independently screened the literature, extracted data and evaluated the quality according to the inclusion and exclusion criteria. Revman5.4 software was used for meta-analysis.
Results: A total of 3076 patients were included in 23 studies, including sorafenib combined with TACE group (n=1542) and TACE group (n=1534). The results of meta-analysis showed that sorafenib combined with TACE could increase the objective response rate (ORR) (RR=1.35, 95%CI: 1.24-1.48, p<0.00001), disease control rate (DCR) (RR=1.19, 95%CI: 1.11-1.28, p<0.00001), prolong the time of disease progression (TTP) (HR=0.80, 95%CI: 0.70-0.92, p=0.001), reduce the expression level of alpha-fetoprotein (AFP) (SMD=2.01, 95%CI: 1.27-2.75, p<0.00001) and vascular endothelial growth factor (VEGF) (SMD=2.62, 95% CI: 1.35-3.90, p<0.0001) in serum. However, the overall survival (OS) was not prolonged (HR=0.86, 95%CI: 0.73-1.02, p=0.09). The incidences of fatigue, diarrhea, elevated bilirubin, skin reaction of hands and feet, rash, hypertension and oral mucosal inflammation in sorafenib combined with TACE group were higher than those in TACE group (p<0.05).
Conclusion: Sorafenib combined with TACE has some clinical benefits compared with TACE alone, but it does not seem to prolong the OS of patients with HCC, and the incidence of adverse reactions is higher, so more high-quality RCTs are needed to further study the efficacy of the combination regimen.