A randomised, double-blind, placebo-controlled multi-centre phase III trial of XELIRI/FOLFIRI plus simvastatin for patients with metastatic colorectal cancer
DC Field | Value | Language |
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dc.contributor.author | Lim, S.H. | - |
dc.contributor.author | Kim, T.W. | - |
dc.contributor.author | Hong, Y.S. | - |
dc.contributor.author | Han, S.-W. | - |
dc.contributor.author | Lee, K.-H. | - |
dc.contributor.author | Kang, H.J. | - |
dc.contributor.author | Hwang, I.G. | - |
dc.contributor.author | Lee, J. | - |
dc.contributor.author | Kim, H.S. | - |
dc.contributor.author | Kim, S.T. | - |
dc.contributor.author | Lee, J. | - |
dc.contributor.author | Park, J.O. | - |
dc.contributor.author | Park, S.H. | - |
dc.contributor.author | Park, Y.S. | - |
dc.contributor.author | Lim, H.Y. | - |
dc.contributor.author | Jung, S.-H. | - |
dc.contributor.author | Kang, W.K. | - |
dc.date.available | 2019-03-08T20:37:21Z | - |
dc.date.issued | 2015-11 | - |
dc.identifier.issn | 0007-0920 | - |
dc.identifier.issn | 1532-1827 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/11343 | - |
dc.description.abstract | Background:The purpose of this randomised phase III trial was to evaluate whether the addition of simvastatin, a synthetic 3-hydroxy-3methyglutaryl coenzyme A reductase inhibitor, to XELIRI/FOLFIRI chemotherapy regimens confers a clinical benefit to patients with previously treated metastatic colorectal cancer.Methods:We undertook a double-blind, placebo-controlled phase III trial of 269 patients previously treated for metastatic colorectal cancer and enrolled in 5 centres in South Korea. Patients were randomly assigned (1: 1) to one of the following groups: FOLFIRI/XELIRI plus simvastatin (40 mg) or FOLFIRI/XELIRI plus placebo. The FOLFIRI regimen consisted of irinotecan at 180 mg m -2 as a 90-min infusion, leucovorin at 200 mg m -2 as a 2-h infusion, and a bolus injection of 5-FU 400 mg m -2 followed by a 46-h continuous infusion of 5-FU at 2400 mg m -2. The XELIRI regimen consisted of irinotecan at 250 mg m -2 as a 90-min infusion with capecitabine 1000 mg m -2 twice daily for 14 days. The primary end point was progression-free survival (PFS). Secondary end points included response rate, duration of response, overall survival (OS), time to progression, and toxicity.Results:Between April 2010 and July 2013, 269 patients were enrolled and assigned to treatment groups (134 simvastatin, 135 placebo). The median PFS was 5.9 months (95% CI, 4.5-7.3) in the XELIRI/FOLFIRI plus simvastatin group and 7.0 months (95% CI, 5.4-8.6) in the XELIRI/FOLFIRI plus placebo group (P=0.937). No significant difference was observed between the two groups with respect to OS (median, 15.9 months (simvastatin) vs 19.9 months (placebo), P=0.826). Grade ≥3 nausea and anorexia were noted slightly more often in patients in the simvastatin arm compared with with the placebo arm (4.5% vs 0.7%, 3.0% vs 0%, respectively).Conclusions:The addition of 40 mg simvastatin to the XELIRI/FOLFIRI regimens did not improve PFS in patients with previously treated metastatic colorectal cancer nor did it increase toxicity. © 2015 Cancer Research UK. All rights reserved. | - |
dc.format.extent | 6 | - |
dc.language | 영어 | - |
dc.language.iso | ENG | - |
dc.publisher | Nature Publishing Group | - |
dc.title | A randomised, double-blind, placebo-controlled multi-centre phase III trial of XELIRI/FOLFIRI plus simvastatin for patients with metastatic colorectal cancer | - |
dc.type | Article | - |
dc.identifier.doi | 10.1038/bjc.2015.371 | - |
dc.identifier.bibliographicCitation | British Journal of Cancer, v.113, no.10, pp 1421 - 1426 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.wosid | 000365350300003 | - |
dc.identifier.scopusid | 2-s2.0-84947492288 | - |
dc.citation.endPage | 1426 | - |
dc.citation.number | 10 | - |
dc.citation.startPage | 1421 | - |
dc.citation.title | British Journal of Cancer | - |
dc.citation.volume | 113 | - |
dc.type.docType | Article | - |
dc.publisher.location | 영국 | - |
dc.subject.keywordAuthor | Colorectal cancer | - |
dc.subject.keywordAuthor | simvastatin | - |
dc.subject.keywordAuthor | XELIRI/FOLFIRI chemotherapy | - |
dc.subject.keywordPlus | MEVALONATE PATHWAY | - |
dc.subject.keywordPlus | STATIN USE | - |
dc.subject.keywordPlus | LOVASTATIN | - |
dc.subject.keywordPlus | CELLS | - |
dc.subject.keywordPlus | POTENTIATE | - |
dc.subject.keywordPlus | RESISTANCE | - |
dc.subject.keywordPlus | INHIBITOR | - |
dc.subject.keywordPlus | MUTATIONS | - |
dc.subject.keywordPlus | SURVIVAL | - |
dc.subject.keywordPlus | THERAPY | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.description.journalRegisteredClass | sci | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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