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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)

Franck Bonnetain 1, 2 Bert Bonsing 3 Thierry Conroy 4, 5 Adelaide Dousseau 6, 7 Bengt Glimelius 8 Karin Haustermans 9 François Lacaine 10 Jean Luc van Laethem 11 Thomas Aparicio 12 Daniela Aust 13 Claudio Bassi 14 Virginie Berger 15 Emmanuel Chamorey 16 Benoist Chibaudel 17, 18 Laeticia Dahan 19 Aimery de Gramont 17, 18 Jean Robert Delpero 20 Christos Dervenis 21 Michel Ducreux 22 Jocelyn Gal 16 Erich Gerber 23 Paula Ghaneh 24 Pascal Hammel 25 Alain Hendlisz 26 Valérie Jooste 27, 28 Roberto Labianca 29 Aurélien Latouche 30 Manfred Lutz 31 Teresa Macarulla 32 David Malka 22 Muriel Mauer 33 Emmanuel Mitry 34, 35 John Neoptolemos 24 Patrick Pessaux 36 Alain Sauvanet 37 Josep Tabernero 32 Julien Taieb 38 Geertjan van Tienhoven 39 Sophie Gourgou-Bourgade 40 Carine Bellera 41, 42 Simone Mathoulin-Pélissier 41, 42 Laurence Collette 33 
22 Oncologie digestive
Département de médecine oncologique [Gustave Roussy]
27 Registre Bourguignon des Cancers Digestifs
LNC - Lipides - Nutrition - Cancer (U866), CHU Dijon - Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand
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.
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Submitted on : Tuesday, May 29, 2018 - 3:09:28 PM
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Franck Bonnetain, Bert Bonsing, Thierry Conroy, Adelaide Dousseau, Bengt Glimelius, et al.. 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). European Journal of Cancer, 2014, 50 (17), pp.2983 - 2993. ⟨10.1016/j.ejca.2014.07.011⟩. ⟨hal-01802621⟩



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