Efficacy and safety of lenvatinib versus sorafenib for unresectable hepatocellular carcinoma: A meta-analysis

Abstract Background Although sorafenib was recommended as a first-line systemic therapy to prolong overall survival time in unresectable hepatocellular carcinoma (HCC), two randomized phase 3 noninferiority trials demonstrated that lenvatinib was noninferior to sorafenib in unresectable HCC. Methods This study included three trials containing 1462 patients identified by a database search using standard terms. We conducted the data analysis in Review Manager version 5.3 software. Results The outcomes showed that there were nonsignificant differences in OS of 6, 12, 18, 30 and 36 months, PFS of 18, 24, 30 and 36 months and AEs (grade < 3) between the lenvatinib group and the sorafenib group, and there were significant differences in OS of 24 months (p = 0.01), PFS of 6 (p < 0.00001) and 12 (p < 0.00001) months, ORR (p < 0.00001) and DCR (p < 0.00001) between the lenvatinib group and the sorafenib group. Conclusions Lenvatinib was not superior to sorafenib in terms of OS and AEs, and lenvatinib was superior to sorafenib in terms of secondary endpoints, including PFS, ORR and DCR, in unresectable HCC.