Abstract
Background: The lenvatinib combined with immunotherapy therapies as first-line treatment are still controversial in unresectable hepatocellular carcinoma (uHCC). This research aimed to compare the efficacy and safety of lenvatinib monotherapy (L) and synchronous therapy (LI) and sequential therapy (L-LI) in uHCC patients.
Methods:181 uHCC patients were enrolled in this study. Patients were classified into three groups: (1) Lenvatinib monotherapy (L). (2) Synchronous therapy (LI) (lenvatinib plus immune checkpoint inhibitors (ICIs) at the same time). (3) Sequential therapy (L-LI) (patients were initially treated with lenvatinib monotherapy for 3 months, stable disease remained, followed by subsequent addition of ICIs). Overall survival (OS) and progression-free survival (PFS), baseline characteristics, safety were compared among these groups.
Results: The combination groups (LI, L-LI) had longer OS and PFSthan the L group, and there was no significant difference between the LI group and the L-LI group. However, in the subgroup of patients without distant metastases, the L-LI group exhibited longer PFS compared to the LI group. Conversely, in the subgroup of patients with distant metastases, the LI group showed longer PFS than the L-LI group. The ECOG PS and AFP were independent prognostic factors for survival. The frequency of grade ≥ 3 AEs was not significantly different.
Conclusions: Our study demonstrated that, in all patients, the combination groups (LI, L-LI) had longer OS and PFS than the L group, and there was no significant difference between the LI group and the L-LI group. However, synchronous therapy (LI) has better efficacy in patients with distant metastases, but worse efficacy in patients without distant metastases than sequential therapy (L-LI).