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

Introduction: 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.
Methods: Efficacy and safety were assessed in patient cohorts from REFLECT according to study entry baseline ALBI grade and CPS.
Results: 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.
Conclusions: 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.
Competing Interests: A.V. has provided a speaker, consultancy, and advisory role for Roche, Bayer, Sanofi, BMS, Lilly, Novartis, Eisai, AstraZeneca, Merck, Incyte, Medac, Ipsen, Servier, PierreFabre, MSD, BTG, and Janssen. C.F. serves on speakers' bureaus and advisory boards for Bayer and Eisai. M.S. has received honoraria from advisory board participation from Bayer, Eisai, Exelixis, and Genentech. B.D. has received personal fees and nonfinancial support for consultation from Ipsen, Sanofi, and Bayer; and personal fees from Roche, Eisai, Eli Lilly, AstraZeneca, MSD, and Incyte. A.B. has served on speakers' bureau for Bristol Myers Squibb, Merck, Lilly, Amgen, Eisai, Johnson & Johnson, and AbbVie. S.L.C. has acted as an advisor to AstraZeneca, Eisai, Ipsen, and MSD. J.F.B. has received honoraria from Bayer, Ipsen, Eisai, Roche, BMS, AstraZeneca, and Eli Lilly. T.T. is an employee of and has stock/other ownership with Eisai. M.R. is an employee of Eisai. H.J.L. has nothing to disclose. D.H.P. has received honoraria from Eisai and research funding and honoraria from Bayer, BMS, Roche, AstraZeneca, Sirtex, and BTG. Y.T. has nothing to disclose. M.K. has received honoraria from Merck Sharp & Dohme, Eisai, Bayer, Lilly Japan, EA Pharma, and Bristol Myers Squibb Japan; served in a consulting/advisory role for Merck Sharp & Dohme, Eisai, Ono Pharmaceuticals, Bristol Myers Squibb, and Roche; and received research funding (inst) from Otsuka Pharmaceutical, Taiho Pharmaceutical, AbbVie, Takeda Pharmaceuticals, Eisai, Gilead Sciences, EA Pharma, and Dainippon Sumitomo Pharma. M.K. is the Editor-in-Chief of Liver Cancer.
(Copyright © 2021 by S. Karger AG, Basel.)