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Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative

dc.rights.licenseopenen_US
dc.contributor.authorCOHEN, R.
dc.contributor.authorVERNEREY, D.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorBELLERA, Carine
dc.contributor.authorMEURISSE, A.
dc.contributor.authorHENRIQUES, J.
dc.contributor.authorPAOLETTI, X.
dc.contributor.authorROUSSEAU, B.
dc.contributor.authorALBERTS, S.
dc.contributor.authorAPARICIO, T.
dc.contributor.authorBOUKOVINAS, I.
dc.contributor.authorGILL, S.
dc.contributor.authorGOLDBERG, R. M.
dc.contributor.authorGROTHEY, A.
dc.contributor.authorHAMAGUCHI, T.
dc.contributor.authorIVESON, T.
dc.contributor.authorKERR, R.
dc.contributor.authorLABIANCA, R.
dc.contributor.authorLONARDI, S.
dc.contributor.authorMEYERHARDT, J.
dc.contributor.authorPAUL, J.
dc.contributor.authorPUNT, C. J. A.
dc.contributor.authorSALTZ, L.
dc.contributor.authorSAUNDERS, M. P.
dc.contributor.authorSCHMOLL, H. J.
dc.contributor.authorSHAH, M.
dc.contributor.authorSOBRERO, A.
dc.contributor.authorSOUGLAKOS, I.
dc.contributor.authorTAIEB, J.
dc.contributor.authorTAKASHIMA, A.
dc.contributor.authorWAGNER, A. D.
dc.contributor.authorYCHOU, M.
dc.contributor.authorBONNETAIN, F.
dc.contributor.authorGOURGOU, S.
dc.contributor.authorYOSHINO, T.
dc.contributor.authorYOTHERS, G.
dc.contributor.authorDE GRAMONT, A.
dc.contributor.authorSHI, Q.
dc.contributor.authorANDRE, T.
dc.date.accessioned2021-03-08T13:08:04Z
dc.date.available2021-03-08T13:08:04Z
dc.date.issued2020
dc.identifier.issn0959-8049en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/26458
dc.description.abstractEnBackground The variability of definitions for time-to-event (TTE) end-points impacts the conclusions of randomised clinical trials (RCTs). The Definition for the Assessment of Time-to-event Endpoints in CANcer (DATECAN) initiative aims to provide consensus definitions for TTE end-points used in RCTs. Here, we formulate guidelines for adjuvant colon cancer RCTs. Methods We performed a literature review to identify TTE end-points and events included in their definition in RCT publications. Then, a consensus was reached among a panel of international experts, using a formal modified Delphi method, with 2 rounds of questionnaires and an in-person meeting. Results Twenty-four experts scored 72 events involved in 6 TTE end-points. Consensus was reached for 24%, 57% and 100% events after the first round, second round and in-person meeting. For RCTs not using overall survival as their primary end-point, the experts recommend using disease-free survival (DFS) rather than recurrence-free survival (RFS) or time to recurrence (TTR) as the primary end-point. The consensus definition of DFS includes all causes of death, second primary colorectal cancers (CRCs), anastomotic relapse and metastatic relapse as an event, but not second primary non-CRCs. Events included in the RFS definition are the same as for DFS with the exception of second primary CRCs. The consensus definition of TTR includes anastomotic or metastatic relapse, death with evidence of recurrence and death from CC cause. Conclusion Standardised definitions of TTE end-points ensure the reproducibility of the end-points between RCTs and facilitate cross-trial comparisons. These definitions should be integrated in standard practice for the design, reporting and interpretation of adjuvant CC RCTs.
dc.language.isoENen_US
dc.title.enGuidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative
dc.title.alternativeEur J Canceren_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/j.ejca.2020.02.009en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed32172199en_US
bordeaux.journalEuropean Journal of Canceren_US
bordeaux.page63-71en_US
bordeaux.volume130en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - U1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamEPICENE_BPH
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03162302
hal.version1
hal.date.transferred2021-03-08T13:08:10Z
hal.exporttrue
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