TY - JOUR
T1 - Efficacy and safety of cabozantinib for patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade
AU - Kelley, Robin Kate
AU - Miksad, Rebecca
AU - Cicin, Irfan
AU - Chen, YenHsun
AU - Klümpen, Heinz-Josef
AU - Kim, Stefano
AU - Lin, Zhong-Zhe
AU - Youkstetter, Jillian
AU - Hazra, Saswati
AU - Sen, Suvajit
AU - Cheng, Ann-Lii
AU - el-Khoueiry, Anthony B.
AU - Meyer, Tim
AU - Abou-Alfa, Ghassan K.
N1 - Funding Information: Medical writing assistance provided by Michael Raffin and Alan Saltzman, PhD (Fishawack Communications, Conshohocken, PA) and funded by Exelixis. Funding Information: This study was supported by Exelixis, Inc. Publisher Copyright: © 2021, The Author(s).
PY - 2022/3
Y1 - 2022/3
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85116817676&partnerID=8YFLogxK
U2 - https://doi.org/10.1038/s41416-021-01532-5
DO - https://doi.org/10.1038/s41416-021-01532-5
M3 - Article
C2 - 34621044
SN - 0007-0920
VL - 126
SP - 569
EP - 575
JO - British journal of cancer
JF - British journal of cancer
IS - 4
ER -