Trends in endpoint selection in clinical trials of advanced breast cancer
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Song, Seung Yeon | - |
dc.contributor.author | Seo, Heenam | - |
dc.contributor.author | Kim, Gyungjin | - |
dc.contributor.author | Kim, Ah Rong | - |
dc.contributor.author | Kim, Eun Young | - |
dc.date.available | 2019-01-22T14:22:22Z | - |
dc.date.issued | 2016-11 | - |
dc.identifier.issn | 0171-5216 | - |
dc.identifier.issn | 1432-1335 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/cau/handle/2019.sw.cau/1639 | - |
dc.description.abstract | The selection of appropriate endpoints is crucial for the evaluation of clinical benefits and approval of novel anticancer agents. To our knowledge, this is the first study to evaluate endpoint selection and the shift in trends in phase II and phase III trials of advanced breast cancer treatment. All phase II and phase III trials of advanced breast cancer registered in the ClinicalTrials.gov registry between October 2000 and September 2012 were included in our study. Two study periods were considered for comparison: October 2000 to September 2007 (cohort A) and October 2007 to September 2012 (cohort B). Information on primary and secondary outcome measures, as well as trial characteristics, was extracted by two independent reviewers. Of the 398 phase II and 120 phase III trials, the most frequently intended primary endpoint was progression-free survival (phase II: 28.1 %; phase III: 50.0 %). For phase II trials, a shifting trend in primary outcome was observed from cohort A to cohort B: the use of objective response rate, the most frequently intended primary outcome, significantly declined (cohort A: 60.6 %; cohort B: 39.0 %; P < 0.001), while the use of progression-free survival significantly increased (cohort A: 35.9 %; cohort B: 66.1 %; P < 0.001). Progression-free survival is the most frequently intended primary outcome measure in phase II and phase III trials of advanced breast cancer treatment, with a shifting trend observed from objective response rate to progression-free survival in phase II trials. | - |
dc.format.extent | 11 | - |
dc.publisher | SPRINGER | - |
dc.title | Trends in endpoint selection in clinical trials of advanced breast cancer | - |
dc.type | Article | - |
dc.identifier.doi | 10.1007/s00432-016-2221-5 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY, v.142, no.11, pp 2403 - 2413 | - |
dc.description.isOpenAccess | N | - |
dc.identifier.wosid | 000385664800020 | - |
dc.identifier.scopusid | 2-s2.0-84984799838 | - |
dc.citation.endPage | 2413 | - |
dc.citation.number | 11 | - |
dc.citation.startPage | 2403 | - |
dc.citation.title | JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY | - |
dc.citation.volume | 142 | - |
dc.type.docType | Article | - |
dc.publisher.location | 독일 | - |
dc.subject.keywordAuthor | Breast cancer | - |
dc.subject.keywordAuthor | Phase II/phase III | - |
dc.subject.keywordAuthor | Trial registration | - |
dc.subject.keywordAuthor | Endpoint selection | - |
dc.subject.keywordAuthor | Outcome measures | - |
dc.subject.keywordAuthor | ClinicalTrials.gov | - |
dc.subject.keywordPlus | PROGRESSION-FREE SURVIVAL | - |
dc.subject.keywordPlus | RANDOMIZED CONTROLLED-TRIALS | - |
dc.subject.keywordPlus | CIRCULATING TUMOR-CELLS | - |
dc.subject.keywordPlus | METASTATIC COLORECTAL-CANCER | - |
dc.subject.keywordPlus | PHASE-III TRIALS | - |
dc.subject.keywordPlus | QUALITY-OF-LIFE | - |
dc.subject.keywordPlus | RESPONSE RATE | - |
dc.subject.keywordPlus | OBJECTIVE RESPONSE | - |
dc.subject.keywordPlus | TARGETED AGENTS | - |
dc.subject.keywordPlus | ONCOLOGY | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.description.journalRegisteredClass | sci | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.
84, Heukseok-ro, Dongjak-gu, Seoul, Republic of Korea (06974)02-820-6194
COPYRIGHT 2019 Chung-Ang University All Rights Reserved.
Certain data included herein are derived from the © Web of Science of Clarivate Analytics. All rights reserved.
You may not copy or re-distribute this material in whole or in part without the prior written consent of Clarivate Analytics.