Safety and efficacy of sunitinib in patients with advanced hepatocellular carcinoma: an open-label, multicentre, phase II study
DC Field | Value | Language |
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dc.contributor.author | Faivre, Sandrine | - |
dc.contributor.author | Raymond, Eric | - |
dc.contributor.author | Boucher, Eveline | - |
dc.contributor.author | Douillard, Jean | - |
dc.contributor.author | Lim, Ho Y. | - |
dc.contributor.author | Kim, Jun S. | - |
dc.contributor.author | Zappa, Magaly | - |
dc.contributor.author | Lanzalone, Silvana | - |
dc.contributor.author | Lin, Xun | - |
dc.contributor.author | DePrimo, Samuel | - |
dc.contributor.author | Harmon, Charles | - |
dc.contributor.author | Ruiz-Garcia, Ana | - |
dc.contributor.author | Lechuga, Maria J. | - |
dc.contributor.author | Cheng, Ann Lii | - |
dc.date.accessioned | 2021-09-08T15:03:40Z | - |
dc.date.available | 2021-09-08T15:03:40Z | - |
dc.date.created | 2021-06-10 | - |
dc.date.issued | 2009-08 | - |
dc.identifier.issn | 1470-2045 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/119547 | - |
dc.description.abstract | Background Hepatocellular carcinoma (HCC) tumour spread is partly dependent on neoangiogenesis. In this open-label, multicentre, phase II trial done in Europe and Asia, sunitinib, a multitargeted tyrosine-kinase inhibitor with anti-angiogenic properties, was assessed in patients with advanced unresectable HCC. Methods Between February and July, 2006, eligible patients were enrolled and treated with repeated cycles of oral sunitinib (50 mg/day for 4 weeks, followed by 2 weeks off treatment). The primary endpoint of this Simon two-stage phase II trial was objective response rate according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria, with an expected response rate of 15%. This trial is registered with ClinicalTrials.gov, number NCT00247676. Findings Of 37 patients enrolled, one (2.7%) patient experienced a confirmed partial response, giving an overall objective response rate of 2.7% (95% CI 0.1-14.2); on the basis of this, the trial did not proceed to the second stage. 13 (35%) of 37 patients achieved stable disease for over 3 months. Commonly observed grade 3 and 4 adverse events included thrombocytopenia (14 of 37; 37.8%), neutropenia (nine of 37; 24.3%), asthenia (five of 37; 13.5%), hand-foot syndrome (four of 37; 10.8%), and anaemia (four of 37; 10.8%). There were four deaths among the 37 patients (10.8%) that were possibly related to treatment. Interpretation Sunitinib showed pronounced toxicities at a dose of 50 mg/day in patients with unresectable HCC. The response rate was low, and the study did not meet the primary endpoint based on RECIST criteria. Funding Pfizer Oncology. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCIENCE INC | - |
dc.subject | TYROSINE KINASE INHIBITOR | - |
dc.subject | ENDOTHELIAL GROWTH-FACTOR | - |
dc.subject | ANTITUMOR-ACTIVITY | - |
dc.subject | SU11248 | - |
dc.subject | VEGF | - |
dc.subject | SORAFENIB | - |
dc.subject | TARGET | - |
dc.subject | ALPHA | - |
dc.title | Safety and efficacy of sunitinib in patients with advanced hepatocellular carcinoma: an open-label, multicentre, phase II study | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Jun S. | - |
dc.identifier.doi | 10.1016/S1470-2045(09)70171-8 | - |
dc.identifier.scopusid | 2-s2.0-67651165187 | - |
dc.identifier.wosid | 000268697700018 | - |
dc.identifier.bibliographicCitation | LANCET ONCOLOGY, v.10, no.8, pp.794 - 800 | - |
dc.relation.isPartOf | LANCET ONCOLOGY | - |
dc.citation.title | LANCET ONCOLOGY | - |
dc.citation.volume | 10 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 794 | - |
dc.citation.endPage | 800 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.subject.keywordPlus | TYROSINE KINASE INHIBITOR | - |
dc.subject.keywordPlus | ENDOTHELIAL GROWTH-FACTOR | - |
dc.subject.keywordPlus | ANTITUMOR-ACTIVITY | - |
dc.subject.keywordPlus | SU11248 | - |
dc.subject.keywordPlus | VEGF | - |
dc.subject.keywordPlus | SORAFENIB | - |
dc.subject.keywordPlus | TARGET | - |
dc.subject.keywordPlus | ALPHA | - |
dc.subject.keywordAuthor | TYROSINE KINASE INHIBITOR | - |
dc.subject.keywordAuthor | ENDOTHELIAL GROWTH-FACTOR | - |
dc.subject.keywordAuthor | RENAL-CELL CARCINOMA | - |
dc.subject.keywordAuthor | ANTITUMOR-ACTIVITY | - |
dc.subject.keywordAuthor | CANCER | - |
dc.subject.keywordAuthor | SU11248 | - |
dc.subject.keywordAuthor | VEGF | - |
dc.subject.keywordAuthor | SORAFENIB | - |
dc.subject.keywordAuthor | THERAPY | - |
dc.subject.keywordAuthor | TARGET | - |
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