Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A Retrospective Multicenter Study

Background: Lenvatinib is approved as the first-line treatment for patients with advanced hepatocellular carcinoma (HCC). The efficacy of lenvatinib in Caucasian real-world patients is insufficiently defined. The purpose of this study was to evaluate the efficacy of lenvatinib in a multicenter cohort (ELEVATOR) from Germany and Austria. Methods: We conducted a retrospective data analysis of 205 patients treated with first-line systemic lenvatinib at 14 different sites. Overall survival, progression-free survival, overall response rate, and adverse event rates were assessed and analyzed. Results: Pa- tients receiving lenvatinib in the real-world setting reached a median overall survival (mOS) of 12.8 months, which was comparable to the results reported from the REFLECT study. mOS and median progression-free survival (mPFS) were superior in those patients who met the inclusion criteria of the REFLECT study compared to patients who failed to meet the inclusion criteria (mOS 15.6 vs. 10.2 months, hazard ratio [HR] 0.55, 95% confidence interval [95% CI]: 0.38-0.81, p = 0.002; mPFS 8.1 vs. 4.8 months, HR 0.65, 95% CI: 0.46-0.91, p = 0.0015). For patients with an impaired liver function according to the albumin-bilirubin (ALBI) grade or reduced ECOG performance status >= 2, survival was significantly shorter compared to patients with sustained liver function (ALBI grade 1) and good performance status (ECOG performance status 0), respectively (HR 1.69, 95% CI: 1.07-2.66, p = 0.023; HR 2.25, 95% CI: 1.19-4.23, p = 0.012). Additionally, macrovascular invasion (HR 1.55, 95% CI: 1.02-2.37,p= 0.041) and an AFP >= 200 ng/mL (HR 1.56, 95% CI: 1.03-2.34, p = 0.034) were confirmed as independent negative prognostic factors in our cohort of patients with advanced HCC. Conclusion: Overall, our data confirm the efficacy of lenvatinib and did not reveal new or unexpected side effects in a large retrospective Caucasian real-world cohort, supporting the use of lenvatinib as a meaningful alternative for patients that cannot be treated with IO-based combinations in first-line HCC. (C) 2022 The Author(s). Published by S. Karger AG, Basel

Automated summary

The study evaluated the efficacy of Lenvatinib in a multicenter cohort from Germany and Austria, showing that patients meeting the inclusion criteria had better survival outcomes. Impaired liver function and other factors had a significant impact on survival time.