Arndt Vogel1, Catherine Frenette2, Max Sung3, Bruno Daniele4, Ari Baron5, Stephen L Chan6, Jean Frédéric Blanc7, Toshiyuki Tamai8, Min Ren9, Howard J Lim10, Daniel H Palmer11, Yuko Takami12, Masatoshi Kudo13. 1. Department of Gastroenterology, Hepatology, and Endocrinology, Hannover Medical School, Hannover, Germany. 2. Department of Transplantation Hepatology, Scripps MD Anderson Cancer Center, La Jolla, California, USA. 3. Department of Hematology-Oncology, Tisch Cancer Institute at Mount Sinai, New York, New York, USA. 4. Department of Oncology, Ospedale del Mare, Napoli, Italy. 5. Department of Clinical Oncology, Pacific Hematology Oncology Associates, San Francisco, California, USA. 6. 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. 7. Department of Clinical Research and Innovation, University Hospital of Bordeaux, Bordeaux, France. 8. Eisai Co., Ltd., Tokyo, Japan. 9. Eisai Inc., Biostatistics, Oncology Business Group, Woodcliff Lake, New Jersey, USA. 10. Department of Medicine, British Columbia Cancer, Vancouver, British Columbia, Canada. 11. Department of Medical Oncology, Liverpool Experimental Cancer Medicine Centre, University of Liverpool, Liverpool, United Kingdom. 12. Department of Hepato-Biliary-Pancreatic Surgery, National Hospital Organization Kyushu Medical Center, Clinical Research Institute, Fukuoka, Japan. 13. Department of Medicine, Kindai University Faculty of Medicine, Osakasayama, Japan.
Abstract
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.
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.
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