Safety and efficacy of lenvatinib in patients with unresectable hepatocellular carcinoma (uHCC) in real-world practice in Korea

초록

Background: We aimed to evaluate the safety and efficacy of lenvatinib in Korean population under real-world practice. Methods: Patients were prospectively entered at 29 clinical sites through an observational post-marketing study in Korea, funded by Eisai. Patients were treated with lenvatinib according to the approved indication of uHCC. For safety analysis, Adverse Drug Reactions (ADRs) were collected. ADR was defined as AEs where the causal relationship with lenvatinib was not ’unlikely’. The efficacy was assessed by investigators as completed response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). Objective response rate (ORR) was defined as CR or PR in the efficacy analysis set. Statistical analysis was conducted to identify which demographic and clinical factors were related to ORR. Results: 658 patients were included in the safety analysis set. The mean daily dose was 7.8mg/day and 10.1mg/day in patients with a body weight of < 60kg and 60kg. The relative dose intensity related to tolerance was 97% and 84%, respectively. ADRs > grade 3 were reported in 1% (8/658). The most common ADRs > grade 3 were ‘palmar-plantar erythrodysaesthesia syndrome’ (0.3%, 2/658). In the efficacy analysis set, 513 patients were included. The results were as follows: CR, 1% (5/513); PR, 13% (66/513); SD, 45% (231/513); and PD, 41% (211/513). Among the demographic and clinical factors, ORR was significantly different depending on the total treatment duration (p <0.001). Conclusions: Lenvatinib in Korean patients with uHCC was generally well tolerated. The efficacy of treatment varied significantly with regards to the total treatment duration. Patients with longer treatment duration showed higher ORR.