LAUSR

Simple Summary Approximately 80% hepatocellular carcinoma (HCC) patients are in intermediate or advanced stages at diagnosis and have lost the chance of curative surgery, resulting in poor prognosis. Lenvatinib was approved in 2018 as a first-line treatment for unresectable HCC. The aim of this study was to evaluate the efficacy and safety of lenvatinib as a first-line treatment for unresectable HCC by reviewing the currently available data and comparing lenvatinib with sorafenib. An overview of 24 studies indicates that lenvatinib can provide better tumor responses and survival benefits as compared with sorafenib for unresectable HCC patients, with a comparable incidence of adverse events. Abstract Lenvatinib was approved in 2018 as a first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). This systematic review and meta-analysis aimed to provide the most updated evidence about the efficacy and safety of lenvatinib as a first-line treatment for unresectable HCC. An electronic search of the PubMed database, Web of Science, Embase, and Cochrane Library was undertaken to identify all relevant studies up to May 2022. The pooled effect sizes were calculated based on the random-effects model. One phase III randomized controlled trial and 23 retrospective studies of 2438 patients were eligible for analysis. For patients treated with lenvatinib as first-line treatment, the pooled median overall survival (OS), median progression-free survival (PFS), 1-year OS rate, 1-year PFS rate, objective response rate (ORR), and disease control rate (DCR) were 11.36 months, 6.68 months, 56.0%, 27.0%, 36.0% and 75.0%, respectively. Lenvatinib showed a significantly superior efficacy compared with sorafenib (HR for OS, 0.85 and HR for PFS, 0.72; OR for ORR, 4.25 and OR for DCR, 2.23). The current study demonstrates that lenvatinib can provide better tumor responses and survival benefits than sorafenib as a first-line treatment for unresectable HCC, with a comparable incidence of adverse events.