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

TitleALBI score and outcomes in patients with hepatocellular carcinoma: post hoc analysis of the randomized controlled trial KEYNOTE-240
Authors
KeywordsPD-1 inhibitor
albumin-bilirubin score
hepatocellular carcinoma
liver function
pembrolizumab
Issue Date2021
PublisherSAGE Publications (UK and US): Open Access Titles. The Journal's web site is located at https://journals.sagepub.com/home/tama
Citation
Therapeutic Advances in Medical Oncology, , v. 13, p. article no. 17588359211039928 How to Cite?
AbstractAims: 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.
Persistent Identifierhttp://hdl.handle.net/10722/305854
ISSN
2023 Impact Factor: 4.3
2023 SCImago Journal Rankings: 1.529
PubMed Central ID
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorVogel, A-
dc.contributor.authorMerle, P-
dc.contributor.authorVerslype, C-
dc.contributor.authorFinn, RS-
dc.contributor.authorZhu, AX-
dc.contributor.authorCheng, AL-
dc.contributor.authorChan, SL-
dc.contributor.authorYau, T-
dc.contributor.authorRyoo, BY-
dc.contributor.authorKnox, J-
dc.contributor.authorDaniele, B-
dc.contributor.authorQin, S-
dc.contributor.authorWei, Z-
dc.contributor.authorMiteva, Y-
dc.contributor.authorMalhotra, U-
dc.contributor.authorSiegel, AB-
dc.contributor.authorKudo, M-
dc.date.accessioned2021-10-20T10:15:16Z-
dc.date.available2021-10-20T10:15:16Z-
dc.date.issued2021-
dc.identifier.citationTherapeutic Advances in Medical Oncology, , v. 13, p. article no. 17588359211039928-
dc.identifier.issn1758-8340-
dc.identifier.urihttp://hdl.handle.net/10722/305854-
dc.description.abstractAims: 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.-
dc.languageeng-
dc.publisherSAGE Publications (UK and US): Open Access Titles. The Journal's web site is located at https://journals.sagepub.com/home/tama-
dc.relation.ispartofTherapeutic Advances in Medical Oncology-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectPD-1 inhibitor-
dc.subjectalbumin-bilirubin score-
dc.subjecthepatocellular carcinoma-
dc.subjectliver function-
dc.subjectpembrolizumab-
dc.titleALBI score and outcomes in patients with hepatocellular carcinoma: post hoc analysis of the randomized controlled trial KEYNOTE-240-
dc.typeArticle-
dc.identifier.emailYau, T: tyaucc@hku.hk-
dc.identifier.authorityYau, T=rp01466-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1177/17588359211039928-
dc.identifier.pmid34616489-
dc.identifier.pmcidPMC8488519-
dc.identifier.scopuseid_2-s2.0-85116245021-
dc.identifier.hkuros328199-
dc.identifier.volume13-
dc.identifier.spagearticle no. 17588359211039928-
dc.identifier.epagearticle no. 17588359211039928-
dc.identifier.isiWOS:000703728300005-
dc.publisher.placeUnited Kingdom-

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