Title: 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)
Authors: Bonnetain, F ×
Bonsing, B
Conroy, T
Dousseau, A
Glimelius, B
Haustermans, Karin
Lacaine, F
Van Laethem, J
Aparicio, T
Aust, D
Bassi, C
Berger, V
Chamorey, E
Chibaudel, B
Dahan, L
De Gramont, A
Delpero, J
Dervenis, C
Ducreux, M
Gal, J
Gerber, E
Ghaneh, P
Hammel, P
Hendlisz, A
Jooste, V
Labianca, R
Latouche, A
Lutz, M
Macarulla, T
Malka, D
Mauer, M
Mitry, E
Neoptolemos, J
Pesseau, P
Sauvanet, A
Tabernero, J
Taieb, J
van Tienhoven, G
Gourgou-Bourgade, S
Bellera, C
Mathoulin-Pélissier, S
Collette, L #
Issue Date: Nov-2014
Publisher: Pergamon
Series Title: European Journal of Cancer vol:50 issue:17 pages:2983-2993
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.

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).

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.

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.
ISSN: 0959-8049
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Laboratory of Experimental Radiotherapy
× corresponding author
# (joint) last author

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