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Abstract Details
Efficacy and safety of cabozantinib for patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade
Br J Cancer. 2022 Mar;126(4):569-575. doi: 10.1038/s41416-021-01532-5.Epub 2021 Oct 7.
1UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA. katie.kelley@ucsf.edu.
2Beth Israel Deaconess Medical Center, Boston, MA, USA.
3Flatiron Health, Inc, New York, NY, USA.
4Boston Medical Center, Boston, MA, USA.
5Trakya University, Edirne, Turkey.
6The Chinese University of Hong Kong, Hong Kong, China.
7Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.
8Centre Hospitalier Régional Universitaire de Besançon, Besançon, France.
9National Taiwan University Hospital, Taipei, Taiwan.
10Exelixis, Inc, Alameda, CA, USA.
11USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
12Royal Free Hospital, University College London, London, UK.
13Memorial Sloan Kettering Cancer Center, New York, NY, USA.
14Weill Medical College at Cornell University, New York, NY, USA.
#Contributed equally.
Abstract
Background: Albumin-bilirubin (ALBI) grade is an objective measure of liver function for patients with hepatocellular carcinoma (HCC). The tyrosine kinase inhibitor cabozantinib is approved for patients with advanced HCC who have received prior sorafenib based on the phase 3 CELESTIAL trial (NCT01908426). Cabozantinib improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with previously treated HCC.
Methods: Patients were randomised 2:1 to receive cabozantinib 60 mg or placebo orally every day. Clinical outcomes in patients with ALBI grade 1 or 2 at baseline were evaluated in CELESTIAL. ALBI scores were retrospectively calculated based on baseline serum albumin and total bilirubin, with an ALBI grade of 1 defined as ≤ -2.60 score and a grade of 2 as a score of > -2.60 to ≤ -1.39.
Results: Cabozantinib improved OS and PFS versus placebo in both ALBI grade 1 (hazard ratio [HR] [95% CI]: 0.63 [0.46-0.86] and 0.42 [0.32-0.56]) and ALBI grade 2 (HR [95% CI]: 0.84 [0.66-1.06] and 0.46 [0.37-0.58]) subgroups. Adverse events were consistent with those in the overall population. Rates of grade 3/4 adverse events associated with hepatic decompensation were generally low and were more common among patients in the ALBI grade 2 subgroup.
Discussion: These results provide initial support of cabozantinib in patients with advanced HCC irrespective of ALBI grade 1 or 2.