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

Welland S, Leyh C, Finkelmeier F, Jefremow A, Shmanko K, Gonzalez-Carmona MA, Kandulski A, Jeliazkova P, Best J, Fründt TW, Djanani A, Pangerl M, Maieron A, Greil R, Fricke C, Sookthai D, Günther R, Schmiderer A, Wege H, Venerito M, Ehmer U, Müller M, Strassburg CP, Weinmann A, Siebler J, Waidmann O, Lange CM, Saborowski A, Vogel A (2022)

Publication Type: Journal article

Publication year: 2022

Journal

Book Volume: 11

Pages Range: 219-232

Journal Issue: 3

DOI: 10.1159/000521746

Abstract

Background Lenvatinib is approved as 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 multi-center cohort (ELEVATOR) from Germany and Austria. Methods A retrospective data analysis of 205 patients treated with first-line systemic lenvatinib at 14 different sites was conducted. Overall survival, progression free survival, overall response rate and adverse event rates were assessed and analyzed. Results Patients receiving lenvatinib in the real-world setting reached a median overall survival of 12.8 months, which was comparable to the results reported from the REFLECT study. Median overall survival (mOS) and progression free survival (mPFS) was 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, HR 0.55, 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 as first-line treatment and did not reveal new or unexpected side effects in a large retrospective Caucasian real-world cohort, supporting the use of lenvatinib as meaningful alternative for patients that cannot be treated with IO-based combinations in first-line HCC.

Involved external institutions

Klinikum rechts der Isar Germany (DE) Universitätsklinikum Bonn Germany (DE) Institut für Klinische Krebsforschung IKF GmbH Germany (DE) Universitätsklinikum Regensburg Germany (DE) Universitätsmedizin der Johannes Gutenberg-Universität Mainz Germany (DE) Karl Landsteiner Privatuniversität für Gesundheitswissenschaften GmbH Austria (AT) Klinik der Medizinischen Universität Innsbruck Austria (AT) Medizinische Hochschule Hannover (MHH) / Hannover Medical School Germany (DE) Universitätsklinikum Frankfurt am Main (KGU) Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) Germany (DE) Universitätsklinikum Essen Germany (DE) Universitätsklinikum Knappschaftskrankenhaus Bochum Germany (DE) Otto-von-Guericke-Universität Magdeburg Germany (DE)

How to cite

APA:

Welland, S., Leyh, C., Finkelmeier, F., Jefremow, A., Shmanko, K., Gonzalez-Carmona, M.A.,... Vogel, A. (2022). Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A Retrospective Multicenter Study. Liver Cancer, 11(3), 219-232. https://doi.org/10.1159/000521746

MLA:

Welland, Sabrina, et al. "Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A Retrospective Multicenter Study." Liver Cancer 11.3 (2022): 219-232.

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