Efficacy and safety of lenvatinib in patients with recurrent hepatocellular carcinoma after liver transplantation: A retrospective analysis

Background: Lenvatinib is approved for patients with metastatic or recurrent hepatocellular carcinoma (HCC); however, its clinical outcomes in patients experiencing HCC recurrence after liver transplantation (LT) remain unclear. Thus, we investigated the efficacy and safety of lenvatinib in patients with recurrent HCC after LT. Methods: This multinational, multicenter, retrospective study included 45 patients with recurrent HCC after LT who received lenvatinib at six institutions in three countries (Korea, Italy, and Hong Kong) from June 2017 to October 2021. Results: At the time of lenvatinib initiation, 95.6% (n = 43) of patients were Child–Pugh A, with 35 (77.8%) and 10 (22.2%) patients classified as albumin-bilirubin (ALBI) grades 1 and 2, respectively. The objective response rate was 20.0%. With a median follow-up duration of 12.9 months (95% confidence interval [CI]: 11.2–14.7), median progression-free survival and overall survival (OS) were 7.6 (95% CI: 5.3–9.8) months, and 14.5 (95% CI: 0.8–28.2) months, respectively. Patients with ALBI grade 1 showed significantly better OS (52.3 months, [95% CI: not assessable]) than patients with ALBI grade 2 (11.1 months [95% CI: 0.0–30.4 months], p = 0.003). The most common adverse events were hypertension (n = 25, 55.6%), fatigue (n = 17, 37.8%), and anorexia (n = 14, 31.1%). Conclusion: Lenvatinib showed consistent efficacy and toxicity profiles in patients with recurrent HCC after LT compared to the results of previous studies of non-LT HCC patients. The baseline ALBI grade was correlated with better OS in lenvatinib-treated patients with LT.