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Guidelines for time-to-event end-point definitions in trials for pancreatic cancer: Results of the DATECAN initiative (Definition for the Assessment of Time-to-event End-points in CANcer trials)
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2014 (English)In: European Journal of Cancer, ISSN 0959-8049, E-ISSN 1879-0852, Vol. 50, no 17, 2983-2993 p.Article, review/survey (Refereed) Published
Abstract [en]

Background: Using potential surrogate end-points for overall survival (OS) such as Disease-Free- (DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled trials (RCTs). However, end-points are too often imprecisely defined which largely contributes to a lack of homogeneity across trials, hampering comparison between them. The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points in CANcer trials)-Pancreas project is to provide guidelines for standardised definition of time-to-event end-points in RCTs for pancreatic cancer. Methods: Time-to-event end-points currently used were identified from a literature review of pancreatic RCT trials (2006-2009). Academic research groups were contacted for participation in order to select clinicians and methodologists to participate in the pilot and scoring groups (>30 experts). A consensus was built after 2 rounds of the modified Delphi formal consensus approach with the Rand scoring methodology (range: 1-9). Results: For pancreatic cancer, 14 time to event end-points and 25 distinct event types applied to two settings (detectable disease and/or no detectable disease) were considered relevant and included in the questionnaire sent to 52 selected experts. Thirty experts answered both scoring rounds. A total of 204 events distributed over the 14 end-points were scored. After the first round, consensus was reached for 25 items; after the second consensus was reached for 156 items; and after the face-to-face meeting for 203 items. Conclusion: The formal consensus approach reached the elaboration of guidelines for standardised definitions of time-to-event end-points allowing cross-comparison of RCTs in pancreatic cancer.

Place, publisher, year, edition, pages
2014. Vol. 50, no 17, 2983-2993 p.
National Category
Cancer and Oncology
URN: urn:nbn:se:uu:diva-240761DOI: 10.1016/j.ejca.2014.07.011ISI: 000344628300012PubMedID: 25256896OAI: oai:DiVA.org:uu-240761DiVA: diva2:780084
Available from: 2015-01-13 Created: 2015-01-08 Last updated: 2015-01-13Bibliographically approved

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Glimelius, Bengt
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Department of Immunology, Genetics and Pathology
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