Effectiveness and safety of lenvatinib plus anti-programmed death-1 antibodies in patients with hepatocellular carcinoma: A real-world cohort study

Objective: Lenvatinib plus anti-programmed death -1 (anti -PD -1) antibody combinations have shown potent anti -tumor effect in phase I/II trials in advanced or unresectable hepatocellular carcinoma (HCC), but real -world data are limited.Methods: To investigate the effectiveness and safety of lenvatinib plus anti -PD -1 antibodies in a real -world cohort, we retrospectively evaluated 210 patients with unresectable or advanced HCC treated with these regimens between October 2018 and February 2022.Results: The objective response rate and disease control rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 were 28.1% and 75.2%. Median overall survival (OS) and progression -free survival (PFS) in the overall cohort were 17.2 and 8.4 months, respectively. Median OS and PFS of patients receiving first -line treatment reached 18.9 and 9.6 months. Median OS was significantly longer in patients with Child -Pugh class A versus B (18.8 vs. 5.9 months, respectively), as was median PFS (9.1 vs. 4.4 months). Patients with albumin- bilirubin (ALBI) grade 1 versus grade 2/3 also had significantly greater median OS (23.5 vs. 13.4 months). Treatment-related adverse events (AEs) occurred in 79.5% of patients. Patients with ALBI grade 2/3 had a higher rate of grade 3/4 AEs than patients with ALBI grade 1 (57.5% vs. 38.5%).Conclusion: Lenvatinib combined with anti -PD -1 antibody therapy was effective in patients with sufficient liver function reserve. Further study is needed to improve therapeutic efficacy and AE management in patients with Child -Pugh class B or ALBI grade 2/3.