Abstract
BackgroundAlbumin-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.MethodsPatients 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.ResultsCabozantinib 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.DiscussionThese results provide initial support of cabozantinib in patients with advanced HCC irrespective of ALBI grade 1 or 2.Trial registration numberClinicalTrials.gov number, NCT01908426.
Highlights
Albumin-bilirubin (ALBI) grade is an objective measure of liver function for patients with hepatocellular carcinoma (HCC)
Within the Child-Pugh A category, patients can be furthered categorised by ALBI score, most often corresponding to ALBI grade 1 or ALBI grade 2; with higher ALBI grades associated with worse liver dysfunction and overall poor prognosis [4, 5]
Hepatitis C was present in 17% of patients in the cabozantinib arm versus 15% in the placebo arm in the ALBI grade 1 subgroup and 28% of patients in the cabozantinib arm versus 29% in the placebo arm in the ALBI grade 2 subgroup
Summary
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. In the phase 3 CELESTIAL trial, cabozantinib, a tyrosine kinase inhibitor, which inhibits MET, VEGFR and AXL, significantly improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with previously treated advanced HCC [3, 6]. Considering the limitations of Child-Pugh scoring, and to better delineate the potential impact of liver function on treatment outcomes in CELESTIAL, we assessed key outcomes based on ALBI grade at study baseline
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