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) - Université de Lorraine Access content directly
Journal Articles European Journal of Cancer Year : 2014

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)

1 CEF2P / CARCINO - Carcinogénèse épithéliale : facteurs prédictifs et pronostiques - UFC (UR 3181)
2 UNICANCER
3 LUMC - Leiden University Medical Center
4 APEMAC - Maladies chroniques, santé perçue, et processus d'adaptation
5 UNICANCER/ICL - Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy]
6 Université Victor Segalen - Bordeaux 2
7 CHU Bordeaux
8 Uppsala Universitet [Uppsala]
9 University Hospitals Leuven [Leuven]
10 CHU Tenon [AP-HP]
11 ULB - Hôpital Erasme [Bruxelles]
12 Service de Gastro-entérologie [Avicenne]
13 DRESDEN - CGCU - Carl Gustav Carus University
14 UNIVR - Università degli studi di Verona = University of Verona
15 UNICANCER/ICO - Institut de Cancérologie de l'Ouest [Angers/Nantes]
16 UNICANCER/CAL - Centre de Lutte contre le Cancer Antoine Lacassagne [Nice]
17 CHU Saint-Antoine [AP-HP]
18 GERCOR - Cooperator Multidisciplinary Oncology Group
19 Service d'oncologie digestive et hépato-gastro-entérologie [Hôpital de la Timone - APHM]
20 IPC - Institut Paoli-Calmettes
21 Konstantopoulio - Agia Olga Hospital [Athènes]
22 Oncologie digestive
23 Institut für Radioonkologie
24 Royal Liverpool University Hospital
25 Service de Gastroentérologie [Hôpital Beaujon]
26 Institut Jules Bordet [Bruxelles]
27 Registre Bourguignon des Cancers Digestifs
28 LNC - Lipides - Nutrition - Cancer (U866)
29 Azienda Ospedaleria Ospedali Riuniti di Bergamo
30 CESP - Centre de recherche en épidémiologie et santé des populations
31 CaritasKlinikum Saarbrücken
32 Vall d'Hebron University Hospital [Barcelona]
33 EORTC - European Organisation for Research and Treatment of Cancer [Bruxelles]
34 Institut Curie [Paris]
35 CRLCC René Huguenin - CRLCC René Huguenin
36 IHU Strasbourg - L'Institut hospitalo-universitaire de Strasbourg
37 Service d’Hépatologie [Hôpital Beaujon]
38 Service de gastroenterologie [CHU HEGP]
39 Academisch Medisch Centrum bij
40 IRCM - U896 Inserm - UM1 - Institut de recherche en cancérologie de Montpellier
41 Centre d'Investigation Clinique - Epidemiologie Clinique / Essais Cliniques Bordeaux
42 Institut Bergonié [Bordeaux]
Thomas Aparicio
  • Function : Author
  • PersonId : 918754
Jean Robert Delpero
David Malka
  • Function : Author
Julien Taieb

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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Dates and versions

hal-01802621 , version 1 (29-05-2018)

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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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