ALBI score and outcomes in patients with hepatocellular carcinoma: post hoc analysis of the randomized controlled trial KEYNOTE-240

Arndt Vogel, Philippe Merle, Chris Verslype, Richard S. Finn, Andrew X. Zhu, Ann Lii Cheng, Stephen Lam Chan, Thomas Yau, Baek Yeol Ryoo, Jennifer Knox, Bruno Daniele, Shukui Qin, Ziwen Wei, Yanna Miteva, Usha Malhotra, Abby B. Siegel, Masatoshi Kudo

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

Abstract

Aims: This post hoc analysis evaluated albumin/bilirubin (ALBI) score, an objective measure of liver function, in patients receiving pembrolizumab plus best supportive care (BSC) compared with placebo plus BSC in the KEYNOTE-240 study. Methods: Patients with confirmed hepatocellular carcinoma (HCC) and progression after/intolerance to sorafenib, Child–Pugh class A liver function, and Eastern Cooperative Oncology Group performance status of 0–1 were randomly assigned 2:1 to pembrolizumab 200 mg or placebo intravenously every 3 weeks plus BSC for ⩽35 cycles or until confirmed progression/unacceptable toxicity. Outcomes were assessed by ALBI grade. Results: Of 413 patients, at baseline 116 had an ALBI grade 1 score (pembrolizumab, n = 74; placebo, n = 42) and 279 had an ALBI grade 2 score (n = 193; n = 86). Change from baseline in ALBI score to the end of treatment was similar in both arms [difference in least squares mean, −0.039; 95% confidence interval (CI): −0.169 to 0.091]. Time to ALBI grade increase was similar in both arms [median for pembrolizumab versus placebo: 7.8 versus 6.9 months; hazard ratio (HR) = 0.863 (95% CI: 0.625–1.192)]. Regardless of baseline ALBI grade, a trend toward improved overall survival was observed with pembrolizumab [grade 1: HR = 0.725 (95% CI: 0.454–1.158); grade 2: HR = 0.827 (95% CI: 0.612–1.119)]. Conclusion: Pembrolizumab did not adversely impact liver function compared with placebo in patients with HCC, as measured by changes in ALBI scores. A trend toward improved overall survival was observed with pembrolizumab in both ALBI grade groups. ClinicalTrials.gov identifier: NCT02702401.

Original languageEnglish (US)
JournalTherapeutic Advances in Medical Oncology
Volume13
DOIs
StatePublished - 2021

All Science Journal Classification (ASJC) codes

  • Oncology

Keywords

  • PD-1 inhibitor
  • albumin-bilirubin score
  • hepatocellular carcinoma
  • liver function
  • pembrolizumab

Fingerprint

Dive into the research topics of 'ALBI score and outcomes in patients with hepatocellular carcinoma: post hoc analysis of the randomized controlled trial KEYNOTE-240'. Together they form a unique fingerprint.

Cite this