Efficacy and safety of cabozantinib for patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade.

Autor: Kelley RK; UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA. katie.kelley@ucsf.edu., Miksad R; Beth Israel Deaconess Medical Center, Boston, MA, USA.; Flatiron Health, Inc, New York, NY, USA.; Boston Medical Center, Boston, MA, USA., Cicin I; Trakya University, Edirne, Turkey., Chen Y; The Chinese University of Hong Kong, Hong Kong, China., Klümpen HJ; Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands., Kim S; Centre Hospitalier Régional Universitaire de Besançon, Besançon, France., Lin ZZ; National Taiwan University Hospital, Taipei, Taiwan., Youkstetter J; Exelixis, Inc, Alameda, CA, USA., Hazra S; Exelixis, Inc, Alameda, CA, USA., Sen S; Exelixis, Inc, Alameda, CA, USA., Cheng AL; National Taiwan University Hospital, Taipei, Taiwan., El-Khoueiry AB; USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA., Meyer T; Royal Free Hospital, University College London, London, UK., Abou-Alfa GK; Memorial Sloan Kettering Cancer Center, New York, NY, USA.; Weill Medical College at Cornell University, New York, NY, USA.
Jazyk: angličtina
Zdroj: British journal of cancer [Br J Cancer] 2022 Mar; Vol. 126 (4), pp. 569-575. Date of Electronic Publication: 2021 Oct 07.
DOI: 10.1038/s41416-021-01532-5
Abstrakt: 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.
(© 2021. The Author(s).)
Databáze: MEDLINE
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