Abstract
e16152 Background: To assess the efficacy and safety of lenvatinib plus anti-PD-1 versus lenvatinib alone in patients with unresectable hepatocellular carcinoma (u-HCC) and explore the characteristics of the benefit population for combination therapy. Methods: This retrospective study included 70 u-HCC patients that were treated with lenvatinib plus anti-PD-1 and 140 patients treated with lenvatinib alone in Fifth Medical Center of Chinese PLA General Hospital and Electric Power Hospital of Beijing from November 2017 to February 2021. Clinical features were balanced by stabilized inverse probability of treatment weighting (SIPTW). The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). Subpopulation treatment effect pattern plot (STEPP) revealed differential treatment effects. The safety was evaluated by Common Terminology Criteria for AEs version 5.0. Results: During the median follow-up of 21.6 months, 120 (57%) patients died. The combination group showed better OS (21.4 vs. 14 months, p = 0.041), PFS (8.0 vs. 6.3 months, p = 0.015), ORR (38.6% vs. 22.9%, p = 0.026), and DCR (85.7% vs. 69.3%, p = 0.016) than the monotherapy group in unadjusted cohort, which was similar to SIPTW adjusted cohort. The two groups had comparable and manageable AEs. Macrovascular invasion (MVI, HR 2.6, 95%CI 2.18 - 3.92), extrahepatic spread (EHS, HR 2.16, 95%CI 1.49 - 3.13), and Child-Pugh B (CPB, HR 2.08, 95%CI 1.45 - 2.99) were independent factors of OS. Combination therapy improved the 12-month survival rate by 38% for patients with MVI or EHS and CPB, and by up to 18% in the other population. Conclusions: In conclusion, lenvatinib plus anti-PD-1 showed a favorable efficacy and controllable safety for u-HCC patients in real-world practice. The absolute improvement of the 12-month survival rate with combination therapy was more substantial in patients with major vascular invasion or extrahepatic spread and Child-Pugh B.
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