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.
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.