OBJECTIVES: Lenvatinib is approval as first-line treatment of patients with advanced hepatocellular carcinoma (HCC). However, the real-world effectiveness of long-term uses was limited. We aimed to analyze prognostic factors and effectiveness on long-term uses of lenvatinib as first-line in Taiwan.

METHODS: This was a retrospective cohort study by using electronic medication record database in Taiwan. We included the patients with single use of lenvatinib as first-line more than six month from January 2020 to December 2021. The outcomes were overall survival (OS) and the progression-free survival (PFS). We followed each patient from the start using lenvatinib to progression date, death or December 2023. We analyzed baseline and tumor characteristics as prognostic factors, including patients including age, gender, tumor number, size of tumor, portal vein invasion, hepatic vein invasion and presence ascites. Univariable and multivariable Cox regression model was applied for estimating potentially prognostic factors.

RESULTS: We included a total of 117 lenvatinib users with a median age of 64.2 years (SD 12.1) and a median duration of lenvatinib use of 424.0 days (SD 330.4). Of the 117 users, 81.2% were male, and 12.82% had ascites. Additionally, 56.4% of the patients had multiple tumors, 20.51% had a single tumor, 6.8% had hepatic vein invasion, and 47.9% had portal vein invasion. The overall survival (OS) and progression-free survival (PFS) were 24.5 months (21.1 to 32.1) and 13.4 months (11.1 to 17.3), respectively. Based on Cox regression model, hepatic vein invasion was associated with poor OS (HR: 2.4; 95% CI: 1.02-5.58).

CONCLUSIONS: The study demonstrated that long-term use of lenvatinib as a first-line treatment for advanced hepatocellular carcinoma in Taiwan. Hepatic vein invasion was identified as a significant prognostic factor associated with poorer overall survival.