Cited 521 times in
Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial
DC Field | Value | Language |
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dc.contributor.author | 김도영 | - |
dc.date.accessioned | 2017-10-26T07:17:36Z | - |
dc.date.available | 2017-10-26T07:17:36Z | - |
dc.date.issued | 2016 | - |
dc.identifier.issn | 0168-8278 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/151845 | - |
dc.description.abstract | BACKGROUND & AIMS: Transarterial chemoembolization with doxorubicin-eluting beads (DC Bead®; DEB-TACE) is effective in patients with Barcelona clinic liver cancer stage B hepatocellular carcinoma (HCC). The multikinase inhibitor sorafenib enhances overall survival (OS) and time-to-tumor progression (TTP) in patients with advanced HCC. This exploratory phase II trial tested the efficacy and safety of DEB-TACE plus sorafenib in patients with intermediate stage HCC. METHODS: Patients with intermediate stage multinodular HCC without macrovascular invasion (MVI) or extrahepatic spread (EHS) were randomized 1:1 to DEB-TACE (150 mg doxorubicin) plus sorafenib 400 mg twice daily or placebo. The primary endpoint was TTP by blinded central review. Secondary endpoints included time to MVI/EHS, OS, overall response rate (ORR) using modified response evaluation criteria in solid tumors, disease control rate (DCR), time to unTACEable progression (TTUP), and safety. RESULTS: Of 307 patients randomized, 154 received sorafenib and 153 received placebo. Median TTP for subjects receiving sorafenib plus DEB-TACE or placebo plus DEB-TACE was similar (169 vs. 166 days, respectively; hazard ratio (HR) 0.797, p=0.072). Median time to MVI/EHS (HR 0.621, p=0.076) and OS (HR 0.898, p=0.29) had not been reached. The ORRs for patients in the sorafenib and placebo groups with post-baseline scans were 55.9% and 41.3%, respectively, and the DCRs were 89.2% and 76.1%, respectively. TTUP was lower with sorafenib than with placebo (HR 1.586; 95% confidence intervals, 1.200-2.096; median 95 vs. 224 days). No unexpected adverse events related to sorafenib were observed. CONCLUSION: Sorafenib plus DEB-TACE was technically feasible, but the combination did not improve TTP in a clinically meaningful manner compared with DEB-TACE alone. TRIAL REGISTRATION: ClinicalTrials.gov NCT00855218. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | JOURNAL OF HEPATOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Antineoplastic Agents/administration & dosage | - |
dc.subject.MESH | Carcinoma, Hepatocellular/drug therapy* | - |
dc.subject.MESH | Carcinoma, Hepatocellular/pathology | - |
dc.subject.MESH | Chemoembolization, Therapeutic/methods* | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Doxorubicin/administration & dosage* | - |
dc.subject.MESH | Drug Carriers/administration & dosage | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Follow-Up Studies | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Injections, Intra-Arterial | - |
dc.subject.MESH | Liver Neoplasms/drug therapy* | - |
dc.subject.MESH | Liver Neoplasms/pathology | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Neoplasm Staging* | - |
dc.subject.MESH | Niacinamide/administration & dosage | - |
dc.subject.MESH | Niacinamide/analogs & derivatives* | - |
dc.subject.MESH | Phenylurea Compounds/administration & dosage* | - |
dc.subject.MESH | Time Factors | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial | - |
dc.type | Article | - |
dc.publisher.location | Netherlands | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Riccardo Lencioni | - |
dc.contributor.googleauthor | Josep M. Llovet | - |
dc.contributor.googleauthor | Guohong Han | - |
dc.contributor.googleauthor | Won Young Tak | - |
dc.contributor.googleauthor | Jiamei Yang | - |
dc.contributor.googleauthor | Alfredo Guglielmi | - |
dc.contributor.googleauthor | Seung Woon Paik | - |
dc.contributor.googleauthor | Maria Reig | - |
dc.contributor.googleauthor | Do Young Kim | - |
dc.contributor.googleauthor | Gar-Yang Chau | - |
dc.contributor.googleauthor | Angelo Luca | - |
dc.identifier.doi | 10.1016/j.jhep.2016.01.012 | - |
dc.contributor.localId | A00385 | - |
dc.relation.journalcode | J01441 | - |
dc.identifier.eissn | 1600-0641 | - |
dc.identifier.pmid | 26809111 | - |
dc.identifier.url | http://www.sciencedirect.com/science/article/pii/S0168827816000180 | - |
dc.subject.keyword | HCC | - |
dc.subject.keyword | Sorafenib | - |
dc.subject.keyword | TACE | - |
dc.contributor.alternativeName | Kim, Do Young | - |
dc.contributor.affiliatedAuthor | Kim, Do Young | - |
dc.citation.volume | 64 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 1090 | - |
dc.citation.endPage | 1098 | - |
dc.identifier.bibliographicCitation | JOURNAL OF HEPATOLOGY, Vol.64(5) : 1090-1098, 2016 | - |
dc.date.modified | 2017-10-24 | - |
dc.identifier.rimsid | 46170 | - |
dc.type.rims | ART | - |
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