Baseline Liver Function and Subsequent Outcomes in the Phase 3 REFLECT Study of Patients with Unresectable Hepatocellular Carcinoma



Vogel, Arndt, Frenette, Catherine, Sung, Max, Daniele, Bruno, Baron, Ari, Chan, Stephen L, Blanc, Jean Frederic, Tamai, Toshiyuki, Ren, Min, Lim, Howard J
et al (show 3 more authors) (2021) Baseline Liver Function and Subsequent Outcomes in the Phase 3 REFLECT Study of Patients with Unresectable Hepatocellular Carcinoma. LIVER CANCER, 10 (5). pp. 510-521.

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Abstract

<h4>Introduction</h4>Baseline liver function among patients starting treatment for unresectable hepatocellular carcinoma (uHCC) impacts survival and could impact efficacy outcomes and safety profiles of treatments. This post hoc analysis of the phase 3 REFLECT study examined the efficacy and safety outcomes for lenvatinib and for sorafenib in patients with uHCC, assessed by Child-Pugh score (CPS) and albumin-bilirubin (ALBI) grade.<h4>Methods</h4>Efficacy and safety were assessed in patient cohorts from REFLECT according to study entry baseline ALBI grade and CPS.<h4>Results</h4>Lenvatinib treatment generally provided survival benefits in all groups. Median overall survival (OS) among patients with an ALBI grade of 1 was consistently higher than among patients with an ALBI grade of 2 for both the lenvatinib and sorafenib arms (lenvatinib: 17.4 vs. 8.6 months; sorafenib: 14.6 vs. 7.7 months, respectively). Median OS among patients with a CPS of 5 was consistently higher than among patients with a CPS of 6 (lenvatinib: 15.3 vs. 9.4 months; sorafenib: 14.2 vs. 7.9 months, respectively). Progression-free survival and objective response rates for these ALBI grades and CPS demonstrated similar patterns. Among patients who received lenvatinib and experienced a treatment-related treatment-emergent adverse event leading to withdrawal, 6.6% had an ALBI grade of 1, while 13.3% had an ALBI grade of 2, and 7.9% had a CPS of 5, while 12.1% had a CPS of 6.<h4>Conclusions</h4>Better liver function at baseline, as measured by ALBI grade or CPS, may be prognostic for better survival outcomes in patients with uHCC undergoing treatment with lenvatinib or sorafenib.

Item Type: Article
Uncontrolled Keywords: Lenvatinib, Sorafenib, Albumin-bilirubin grade, Child-Pugh score
Divisions: Faculty of Health and Life Sciences
Faculty of Health and Life Sciences > Institute of Systems, Molecular and Integrative Biology
Depositing User: Symplectic Admin
Date Deposited: 18 Jan 2022 09:33
Last Modified: 18 Jan 2023 21:15
DOI: 10.1159/000516490
Open Access URL: https://www.karger.com/Article/FullText/516490
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URI: https://livrepository.liverpool.ac.uk/id/eprint/3147095