Cited 14 times in
Overall survival and objective response in advanced unresectable hepatocellular carcinoma: A subanalysis of the REFLECT study
DC Field | Value | Language |
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dc.contributor.author | 한광협 | - |
dc.date.accessioned | 2024-03-22T06:06:26Z | - |
dc.date.available | 2024-03-22T06:06:26Z | - |
dc.date.issued | 2023-01 | - |
dc.identifier.issn | 0168-8278 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/198399 | - |
dc.description.abstract | Background & Aims: Validated surrogate endpoints for overall survival (OS) are important for expediting the clinical study and drug-development processes. Herein, we aimed to validate objective response as an independent predictor of OS in individuals with unresectable hepatocellular carcinoma (HCC) receiving systemic anti-angiogenic therapy.Methods: We investigated the association between objective response (investigator-assessed mRECIST, independent radiologic review [IRR] mRECIST and RECIST v1.1) and OS in REFLECT, a phase III study of lenvatinib vs. sorafenib. We conducted landmark analyses (Simon-Makuch) of OS by objective response at 2, 4, and 6 months after randomization.Results: Median OS was 21.6 months (95% CI 18.6-24.5) for responders (investigator-assessed mRECIST) vs. 11.9 months (95% CI 10.7-12.8) for non-responders (hazard ratio [HR] 0.61; 95% CI 0.49-0.76; p <0.001). Objective response by IRR per mRECIST and RECIST v1.1 supported the association with OS (HR 0.61; 95% CI 0.51-0.72; p <0.001 and HR 0.50; 95% CI 0.39-0.65; p <0.001, respectively). OS was significantly prolonged for responders vs. non-responders (investigator-assessed mRECIST) at the 2-month (HR 0.61; 95% CI 0.49-0.76;p <0.001), 4-month (HR 0.63; 95% CI 0.51-0.80;p <0.001), and 6-month (HR 0.68; 95% CI 0.54-0.86;p <0.001) landmarks. Results were similar when assessed by IRR, with both mRECIST and RECIST v1.1. An exploratory multivariate Cox regression analysis identified objective response by investigator-assessed mRECIST (HR 0.55; 95% CI 0.44-0.68; p <0.0001) and IRR-assessed RECIST v1.1 (HR 0.49; 95% CI, 0.38-0.64; p <0.0001) as independent predictors of OS in individuals with unresectable HCC.Conclusions: Objective response was an independent predictor of OS in individuals with unresectable HCC in REFLECT; additional studies are needed to confirm surrogacy. Participants achieving a complete or partial response by mRECIST or RECIST v1.1 had significantly longer survival vs. those with stable/progressive/non-evaluable disease.ClinicalTrials.gov number: NCT01761266.(c) 2022 The Authors. Published by Elsevier B.V. on behalf of European Association for the Study of the Liver. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | JOURNAL OF HEPATOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antineoplastic Agents* / therapeutic use | - |
dc.subject.MESH | Carcinoma, Hepatocellular* / pathology | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Liver Neoplasms* / pathology | - |
dc.subject.MESH | Retrospective Studies | - |
dc.subject.MESH | Sorafenib / therapeutic use | - |
dc.title | Overall survival and objective response in advanced unresectable hepatocellular carcinoma: A subanalysis of the REFLECT study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Masatoshi Kudo | - |
dc.contributor.googleauthor | Richard S Finn | - |
dc.contributor.googleauthor | Shukui Qin | - |
dc.contributor.googleauthor | Kwang-Hyub Han | - |
dc.contributor.googleauthor | Kenji Ikeda | - |
dc.contributor.googleauthor | Ann-Lii Cheng | - |
dc.contributor.googleauthor | Arndt Vogel | - |
dc.contributor.googleauthor | Francesco Tovoli | - |
dc.contributor.googleauthor | Kazuomi Ueshima | - |
dc.contributor.googleauthor | Hiroshi Aikata | - |
dc.contributor.googleauthor | Carlos López López | - |
dc.contributor.googleauthor | Marc Pracht | - |
dc.contributor.googleauthor | Zhiqiang Meng | - |
dc.contributor.googleauthor | Bruno Daniele | - |
dc.contributor.googleauthor | Joong-Won Park | - |
dc.contributor.googleauthor | Daniel Palmer | - |
dc.contributor.googleauthor | Toshiyuki Tamai | - |
dc.contributor.googleauthor | Kenichi Saito | - |
dc.contributor.googleauthor | Corina E Dutcus | - |
dc.contributor.googleauthor | Riccardo Lencioni | - |
dc.identifier.doi | 10.1016/j.jhep.2022.09.006 | - |
dc.contributor.localId | A04268 | - |
dc.relation.journalcode | J01441 | - |
dc.identifier.eissn | 1600-0641 | - |
dc.identifier.pmid | 36341767 | - |
dc.subject.keyword | landmark analysis | - |
dc.subject.keyword | lenvatinib | - |
dc.subject.keyword | mRECIST | - |
dc.subject.keyword | response status | - |
dc.subject.keyword | surrogate endpoint | - |
dc.contributor.alternativeName | Han, Kwang Hyub | - |
dc.contributor.affiliatedAuthor | 한광협 | - |
dc.citation.volume | 78 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 133 | - |
dc.citation.endPage | 141 | - |
dc.identifier.bibliographicCitation | JOURNAL OF HEPATOLOGY, Vol.78(1) : 133-141, 2023-01 | - |
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