Welland, Sabrina and Leyh, Catherine and Finkelmeier, Fabian and Jefremow, Andre and Shmanko, Kateryna and Gonzalez-Carmona, Maria A. and Kandulski, Arne and Jeliazkova, Petia and Best, Jan and Fruendt, Thorben W. and Djanani, Angela and Pangerl, Maria and Maieron, Andreas and Greil, Richard and Fricke, Christina and Sookthai, Disorn and Guenther, Rainer and Schmiderer, Andreas and Wege, Henning and Venerito, Marino and Ehmer, Ursula and Mueller, Martina and Strassburg, Christian P. and Weinmann, Arndt and Siebler, Jurgen and Waidmann, Oliver and Lange, Christian M. and Saborowski, Anna and Vogel, Arndt (2022) Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A Retrospective Multicenter Study. LIVER CANCER, 11 (3). pp. 219-232. ISSN 2235-1795, 1664-5553
Full text not available from this repository. (Request a copy)Abstract
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
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | 1ST-LINE TREATMENT; NON-INFERIORITY; SORAFENIB; Lenvatinib; Hepatocellular carcinoma; REFLECT study; Real-world cohort; Liver function; Albumin-bilirubin grade |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Innere Medizin I |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 14 Dec 2023 07:33 |
| Last Modified: | 14 Dec 2023 07:33 |
| URI: | https://pred.uni-regensburg.de/id/eprint/58669 |
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