Lenvatinib combined with immune checkpoint inhibitors for unresectable, recurrent, or metastatic hepatocellular carcinoma: a real-world study.

[BACKGROUND] To investigate the outcomes of combined lenvatinib plus immune checkpoint inhibitors (ICIs) in patients with unresectable, recurrent, or metastatic hepatocellular carcinoma (HCC) in a real-world setting.

[MATERIAL AND METHODS] This retrospective study included patients with unresectable, recurrent, or metastatic HCC who received lenvatinib combined with ICIs at the Fifth Medical Center of the Chinese PLA General Hospital between May 2018 and November 2022. The study outcomes were overall survival (OS), progression-free survival (PFS), and treatment response.

[RESULTS] This study included 117 patients. The objective response rate (comprising both complete and partial responses) was 53.2%. Among those with first-line lenvatinib plus ICI (n = 109), the disease control rate (complete response, partial response, and stable disease) was 89.9%. In all patients, the median OS and PFS were 26.0 (95% CI, 22.0-30.4) and 15.3 (95% CI, 13.2-17.5) months, respectively. In first-line patients, the median OS and PFS were 27.6 (95% CI, 23.4-34.6) and 15.4 (95% CI, 13.4-18.2) months, respectively. Among the 117 patients, treatment was discontinued in 58 (50%) because of AE (n = 9, 16%), PD (n = 43, 74%), or an unknown reason (n = 6, 10%). Among the 117 patients, treatment was interrupted in 26 (22%), and the dose was adjusted in 24 (21%).

[CONCLUSION] This real-world study supports the possibility of using lenvatinib combined with ICI for the management of patients with unresectable, recurrent, or metastatic HCC, including first-line treatment. Confirmation through a formal clinical trial would provide firmer conclusions.