Efficacy and Safety of Lenvatinib in Hepatocellular Carcinoma Patients with Liver Transplantation: A Case-Control Study

SIMPLE SUMMARY: Growing evidence has reported the role of sorafenib in hepatocellular carcinoma (HCC) patients with liver transplantation (LT). However, the clinical impact of lenvatinib in this population is limited. Our study enrolled 10 HCC patients who received lenvatinib after LT in our institute. Partial response was 20% and disease control rate was 70%. The median progression-free survival and overall survival were 3.7 and 16.4 months, respectively. Adverse events (AEs) were predominantly grade 1–2 in severity, and the majority of patients tolerated. Additionally, 25 HCC patients without LT who underwent lenvatinib treatment were identified as the control group; there was no significant difference in survival or AEs between these two groups. The significance of our study is that it is the first to investigate the efficacy and safety of lenvatinib among HCC patients with LT. It provides more information to physicians about the role of lenvatinib in this special population in clinical practice. ABSTRACT: Tumor recurrence is the most common cause of death in hepatocellular carcinoma (HCC) patients who received liver transplantation (LT). Recently, lenvatinib was approved for the systemic treatment of unresectable HCC patients; however, the role of lenvatinib in HCC patients after LT remains unclear. There were 56 patients with recurrent HCC after LT from 2008 to 2018 in our institute, and 10 patients who received lenvatinib were identified. Additionally, to understand the difference in the clinical impact of lenvatinib in the LT and non-LT settings, 25 HCC patients without LT who underwent lenvatinib treatment were identified from our HCC database and regarded as the control group. In the LT group, partial response was 20% and stable disease was 50%, resulting in a disease control rate of 70%; the median progression-free survival (PFS), time to treatment failure (TTF) and overall survival (OS) were 3.7, 3.6 and 16.4 months, respectively. Adverse events (AEs) were predominantly grade 1–2 in severity, and the majority of patients tolerated the side effects. There was no significant difference in PFS/OS, and we observed a similar pattern of AEs between these two groups. Our study confirms the comparable efficacy and safety of lenvatinib in HCC patients with LT and non-LT in clinical practice.