Combining immune checkpoint inhibitor with lenvatinib prolongs survival than lenvatinib alone in sorafenib-experienced hepatocellular carcinoma patients

Background Lenvatinib and immune checkpoint inhibitors (ICIs) were approved as the promising agents for unresectable hepatocellular carcinoma (HCC). Nevertheless, the benefits of combining ICI with lenvatinib in sorafenib-experienced patients remain uncertain. We aimed to investigate whether the combination use of ICI and lenvatinib provides better survival than lenvatinib alone in advanced stage HCC patients. Methods From March 2018 to August 2019, a total of 53 unresectable HCC patients receiving lenvatinib were recruited. Treatment response was evaluated by dynamic image including computed tomography or MRI. Overall survival (OS), progression-free survival (PFS), and predictors for survival were analyzed. Results Among the 53 patients, the median age was 67.2 years old, and 66.4% were male. Twenty-one patients had sorafenib-experienced history. Eighteen patients (34%) died with median follow-up duration of 8.1 months. Patient receiving lenvatinib had median OS of 16.9 [95% confidence interval (CI): 10.1-23.7] months, and PFS of 7.23 (95% CI: 4.8-9.7) months. In multivariate Cox regression analysis, albumin-bilirubin (ALBI) grade III (adjusted HR: 6.699, P = 0.0039) and the history of sorafenib treatment (adjusted HR: 4.476, P = 0.0457) were the independent predictive factor for OS. In sorafenib-experienced patients, those combined treated with ICI (N = 14) showed significantly better survival than monotherapy with lenvatinib (median: 12.8 vs 4.1 months, log-rank P = 0.008). Conclusion The ALBI grade and sorafenib treatment history were predictors for OS in HCC patients receiving lenvatinib. For sorafenib-experienced patients, combining ICI with lenvatinib achieved better OS than lenvatinib alone.