Efficacy and safety of cabozantinib for patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade.
- Resource Type
- journal article
- Authors
- Kelley, Robin Kate; Miksad, Rebecca; Cicin, Irfan; Chen, YenHsun; Klümpen, Heinz-Josef; Kim, Stefano; Lin, Zhong-Zhe; Youkstetter, Jillian; Hazra, Saswati; Sen, Suvajit; Cheng, Ann-Lii; El-Khoueiry, Anthony B.; Meyer, Tim; Abou-Alfa, Ghassan K.
- Source
- British Journal of Cancer. Mar2022, Vol. 126 Issue 4, p569-575. 7p.
- Subject
- *LIVER tumors
*EVALUATION research
*RESEARCH funding
*CLINICAL trials
*BILIRUBIN
*AMIDES
*ORAL drug administration
*TREATMENT effectiveness
*RETROSPECTIVE studies
*PYRIDINE
*RESEARCH
*RESEARCH methodology
*SURVIVAL analysis (Biometry)
*COMPARATIVE studies
*HEPATOCELLULAR carcinoma
*SERUM albumin
*LIVER function tests
- Language
- ISSN
- 0007-0920
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.Trial Registration Number: ClinicalTrials.gov number, NCT01908426. [ABSTRACT FROM AUTHOR]