Baseline Liver Function and Subsequent Outcomes in the Phase 3 REFLECT Study of Patients with Unresectable Hepatocellular Carcinoma
Arndt Vogel,
Catherine Frenette,
Max Sung,
Bruno Daniele,
Ari Baron,
Stephen L. Chan,
Jean Frédéric Blanc,
Toshiyuki Tamai,
Min Ren,
Howard J. Lim,
Daniel H. Palmer,
Yuko Takami,
Masatoshi Kudo
Affiliations
Arndt Vogel
Department of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School, Hannover, Germany
Catherine Frenette
Department of Transplantation Hepatology, Scripps MD Anderson Cancer Center, La Jolla, CA, USA
Max Sung
Department of Hematology-Oncology, Tisch Cancer Institute at Mount Sinai, New York, NY, USA
Bruno Daniele
Department of Oncology, Ospedale del Mare, Napoli, Italy
Ari Baron
Department of Clinical Oncology, Pacific Hematology Oncology Associates, San Francisco, CA, USA
Stephen L. Chan
Department of Clinical Oncology, The State Key Laboratory of Translational Oncology, Sir YK Pao Centre for Cancer, The Chinese University of Hong Kong, Hong Kong, China
Jean Frédéric Blanc
Department of Clinical Research and Innovation, University Hospital of Bordeaux, Bordeaux, France
Toshiyuki Tamai
Eisai Co., Ltd., Tokyo, Japan
Min Ren
Eisai Inc., Biostatistics, Oncology Business Group, Woodcliff Lake, NJ, USA
Howard J. Lim
Department of Medicine, British Columbia Cancer, Vancouver, BC, Canada
Daniel H. Palmer
Department of Medical Oncology, Liverpool Experimental Cancer Medicine Centre, University of Liverpool, Liverpool, United Kingdom
Yuko Takami
Department of Hepato-Biliary-Pancreatic Surgery, National Hospital Organization Kyushu Medical Center, Clinical Research Institute, Fukuoka, Japan
Masatoshi Kudo
Department of Medicine, Kindai University Faculty of Medicine, Osakasayama, Japan
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.
