Lenvatinib as First-line Treatment of Hepatocellular Carcinoma in Patients with Impaired Liver Function in Advanced Liver Cirrhosis: Real World Data and Experience of a Tertiary Hepatobiliary Center

Cosma, Lidia-Sabina; Weigand, Kilian; Müller-Schilling, M; Kandulski, Arne

doi:10.1055/s-0041-1740756

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“…Although the ELEVATOR cohort showed a slightly lower ORR for patients with ALBI 1 liver function, there was a clear difference between ALBI grade 1 and ALBI grade 2 patients in both studies. These data are in line with the strong prognostic impact of liver function in HCC, which has been well documented in retrospective studies, as well as in recent post hoc analyses of the phase-III trials for sorafenib, cabozantinib, ramucirumab, or regorafenib conducted in the first- and second-line setting in advanced HCC [5, 6, 15, 23-26]. Overall, our data support the use of the ALBI grade, which is calculated exclusively on the basis of objectively determined laboratory parameters, as a preferred tool to evaluate liver function and more precisely identify patients with only moderate impairment of liver function especially within the Child-Pugh A cohort [27].…”

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confidence: 79%

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

et al. 2022

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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.

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