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Phase II Randomized Trial Comparing Sequential First-Line Everolimus and Second-Line Sunitinib Versus First-Line Sunitinib and Second-Line Everolimus in Patients With Metastatic Renal Cell Carcinoma
DC Field | Value | Language |
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dc.contributor.author | 라선영 | - |
dc.date.accessioned | 2015-01-06T17:38:50Z | - |
dc.date.available | 2015-01-06T17:38:50Z | - |
dc.date.issued | 2014 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/100368 | - |
dc.description.abstract | PURPOSE: A multicenter, randomized phase II trial, RECORD-3, was conducted to compare first-line everolimus followed by sunitinib at progression with the standard sequence of first-line sunitinib followed by everolimus in patients with metastatic renal cell carcinoma. PATIENTS AND METHODS: RECORD-3 used a crossover treatment design. The primary objective was to assess progression-free survival (PFS) noninferiority of first-line everolimus compared with first-line sunitinib. Secondary end points included combined PFS for each sequence, overall survival (OS), and safety. RESULTS: Of 471 enrolled patients, 238 were randomly assigned to first-line everolimus followed by sunitinib, and 233 were randomly assigned to first-line sunitinib followed by everolimus. The primary end point was not met; the median PFS was 7.9 months for first-line everolimus and 10.7 months for first-line sunitinib (hazard ratio [HR], 1.4; 95% CI, 1.2 to 1.8). Among patients who discontinued first-line, 108 (45%) crossed over from everolimus to second-line sunitinib, and 99 (43%) crossed over from sunitinib to second-line everolimus. The median combined PFS was 21.1 months for sequential everolimus then sunitinib and was 25.8 months for sequential sunitinib then everolimus (HR, 1.3; 95% CI, 0.9 to 1.7). The median OS was 22.4 months for sequential everolimus and then sunitinib and 32.0 months for sequential sunitinib and then everolimus (HR, 1.2; 95% CI, 0.9 to 1.6). Common treatment-emergent adverse events during first-line everolimus or sunitinib were stomatitis (53% and 57%, respectively), fatigue (45% and 51%, respectively), and diarrhea (38% and 57%, respectively). CONCLUSION: Everolimus did not demonstrate noninferiority compared with sunitinib as a first-line therapy. The trial results support the standard treatment paradigm of first-line sunitinib followed by everolimus at progression. | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 2765~2772 | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL ONCOLOGY | - |
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 | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Aged, 80 and over | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/administration & dosage* | - |
dc.subject.MESH | Carcinoma, Renal Cell/drug therapy* | - |
dc.subject.MESH | Carcinoma, Renal Cell/pathology | - |
dc.subject.MESH | Cross-Over Studies | - |
dc.subject.MESH | Disease-Free Survival | - |
dc.subject.MESH | Drug Administration Schedule | - |
dc.subject.MESH | Everolimus | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Indoles/administration & dosage | - |
dc.subject.MESH | Kidney Neoplasms/drug therapy* | - |
dc.subject.MESH | Kidney Neoplasms/pathology | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Neoplasm Metastasis | - |
dc.subject.MESH | Pyrroles/administration & dosage | - |
dc.subject.MESH | Sirolimus/administration & dosage | - |
dc.subject.MESH | Sirolimus/analogs & derivatives | - |
dc.subject.MESH | Treatment Outcome | - |
dc.subject.MESH | Young Adult | - |
dc.title | Phase II Randomized Trial Comparing Sequential First-Line Everolimus and Second-Line Sunitinib Versus First-Line Sunitinib and Second-Line Everolimus in Patients With Metastatic Renal Cell Carcinoma | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학) | - |
dc.contributor.googleauthor | Robert J. Motzer | - |
dc.contributor.googleauthor | Carlos H. Barrios | - |
dc.contributor.googleauthor | Tae Min Kim | - |
dc.contributor.googleauthor | Silvia Falcon | - |
dc.contributor.googleauthor | Thomas Cosgriff | - |
dc.contributor.googleauthor | W. Graydon Harker | - |
dc.contributor.googleauthor | Vichien Srimuninnimit | - |
dc.contributor.googleauthor | Ken Pittman | - |
dc.contributor.googleauthor | Roberto Sabbatini | - |
dc.contributor.googleauthor | Sun Young Rha | - |
dc.contributor.googleauthor | Thomas W. Flaig | - |
dc.contributor.googleauthor | Ray Page | - |
dc.contributor.googleauthor | Sevil Bavbek | - |
dc.contributor.googleauthor | J. Thaddeus Beck | - |
dc.contributor.googleauthor | Poulam Patel | - |
dc.contributor.googleauthor | Foon-yiu Cheung | - |
dc.contributor.googleauthor | Sunil Yadav | - |
dc.contributor.googleauthor | Edward M. Schiff | - |
dc.contributor.googleauthor | Xufang Wang | - |
dc.contributor.googleauthor | Julie Niolat | - |
dc.contributor.googleauthor | Dalila Sellami | - |
dc.contributor.googleauthor | Oezlem Anak | - |
dc.contributor.googleauthor | Jennifer J. Knox | - |
dc.identifier.doi | 10.1200/JCO.2013.54.6911 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A01316 | - |
dc.relation.journalcode | J01331 | - |
dc.identifier.eissn | 1527-7755 | - |
dc.identifier.pmid | 25049330 | - |
dc.identifier.url | http://jco.ascopubs.org/content/32/25/2765.long | - |
dc.contributor.alternativeName | Rha, Sun Young | - |
dc.contributor.affiliatedAuthor | Rha, Sun Young | - |
dc.rights.accessRights | free | - |
dc.citation.volume | 32 | - |
dc.citation.number | 25 | - |
dc.citation.startPage | 2765 | - |
dc.citation.endPage | 2772 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL ONCOLOGY, Vol.32(25) : 2765-2772, 2014 | - |
dc.identifier.rimsid | 49584 | - |
dc.type.rims | ART | - |
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