Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A Retrospective Multicenter Study
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Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A Retrospective Multicenter Study. / Welland, Sabrina; Leyh, Catherine; Finkelmeier, Fabian; Jefremow, André; Shmanko, Kateryna; Gonzalez-Carmona, Maria A; Kandulski, Arne; Jeliazkova, Petia; Best, Jan; Fründt, Thorben W; Djanani, Angela; Pangerl, Maria; Maieron, Andreas; Greil, Richard; Fricke, Christina; Sookthai, Disorn; Günther, Rainer; Schmiderer, Andreas; Wege, Henning; Venerito, Marino; Ehmer, Ursula; Müller, Martina; Strassburg, Christian P; Weinmann, Arndt; Siebler, Jürgen; Waidmann, Oliver; Lange, Christian M; Saborowski, Anna; Vogel, Arndt.
In: LIVER CANCER, Vol. 11, No. 3, 06.2022, p. 219-232.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Real-World Data for Lenvatinib in Hepatocellular Carcinoma (ELEVATOR): A Retrospective Multicenter Study
AU - Welland, Sabrina
AU - Leyh, Catherine
AU - Finkelmeier, Fabian
AU - Jefremow, André
AU - Shmanko, Kateryna
AU - Gonzalez-Carmona, Maria A
AU - Kandulski, Arne
AU - Jeliazkova, Petia
AU - Best, Jan
AU - Fründt, Thorben W
AU - Djanani, Angela
AU - Pangerl, Maria
AU - Maieron, Andreas
AU - Greil, Richard
AU - Fricke, Christina
AU - Sookthai, Disorn
AU - Günther, Rainer
AU - Schmiderer, Andreas
AU - Wege, Henning
AU - Venerito, Marino
AU - Ehmer, Ursula
AU - Müller, Martina
AU - Strassburg, Christian P
AU - Weinmann, Arndt
AU - Siebler, Jürgen
AU - Waidmann, Oliver
AU - Lange, Christian M
AU - Saborowski, Anna
AU - Vogel, Arndt
N1 - Copyright © 2022 by S. Karger AG, Basel.
PY - 2022/6
Y1 - 2022/6
N2 - 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.
AB - 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.
U2 - 10.1159/000521746
DO - 10.1159/000521746
M3 - SCORING: Journal article
C2 - 35949288
VL - 11
SP - 219
EP - 232
JO - LIVER CANCER
JF - LIVER CANCER
SN - 2235-1795
IS - 3
ER -
