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)

Franck Bonnetain, Bert Bonsing, Thierry Conroy, Adelaide Dousseau, Bengt Glimelius, Karin Haustermans, François Lacaine, Jean Luc van Laethem, Thomas Aparicio, Daniela Aust, Claudio Bassi, Virginie Berger, Emmanuel Chamorey, Benoist Chibaudel, Laeticia Dahan, Aimery de Gramont, Jean Robert Delpero, Christos Dervenis, Michel Ducreux, Jocelyn GalErich Gerber, Paula Ghaneh, Pascal Hammel, Alain Hendlisz, Valérie Jooste, Roberto Labianca, Aurelien Latouche, Manfred Lutz, Teresa Macarulla, David Malka, Muriel Mauer, Emmanuel Mitry, John Neoptolemos, Patrick Pessaux, Alain Sauvanet, Josep Tabernero, Julien Taieb, Geertjan van Tienhoven, Sophie Gourgou-Bourgade, Carine Bellera, Simone Mathoulin-Pélissier, Laurence Collette

Research output: Contribution to journalReview articleAcademicpeer-review

Abstract

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.
Original languageEnglish
Pages (from-to)2983-2993
JournalEuropean Journal of Cancer
Volume50
Issue number17
DOIs
Publication statusPublished - 2014
Externally publishedYes

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