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)
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 - Centre Hospitalier Universitaire de Bordeaux
8 Uppsala Universitet [Uppsala]
9 University Hospitals Leuven [Leuven]
10 CHU Tenon [AP-HP]
11 HUB-ULB - Hôpital Erasme = Erasmus Hospital = Erasmus Ziekenhuis
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]
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 - Centre Hospitalier Universitaire de Bordeaux
8 Uppsala Universitet [Uppsala]
9 University Hospitals Leuven [Leuven]
10 CHU Tenon [AP-HP]
11 HUB-ULB - Hôpital Erasme = Erasmus Hospital = Erasmus Ziekenhuis
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]
Thierry Conroy
- Fonction : Auteur
- PersonId : 736936
- IdHAL : thierry-conroy
- ORCID : 0000-0001-7548-284X
- IdRef : 069112150
Emmanuel Chamorey
- Fonction : Auteur
- PersonId : 760333
- ORCID : 0000-0002-6841-4571
Benoist Chibaudel
- Fonction : Auteur
- PersonId : 971355
Aimery de Gramont
- Fonction : Auteur
- PersonId : 761187
- ORCID : 0000-0001-7940-9877
Jean Robert Delpero
- Fonction : Auteur
- PersonId : 764859
- ORCID : 0000-0002-0000-1332
- IdRef : 060900326
Jocelyn Gal
- Fonction : Auteur
- PersonId : 927709
Valérie Jooste
- Fonction : Auteur
- PersonId : 906756
Aurélien Latouche
- Fonction : Auteur
- PersonId : 833118
- ORCID : 0000-0001-9218-0333
- IdRef : 089428870
Patrick Pessaux
- Fonction : Auteur
- PersonId : 1059086
- ORCID : 0000-0001-5635-7437
- IdRef : 06911014X
Julien Taieb
- Fonction : Auteur
- PersonId : 756198
- ORCID : 0000-0002-9955-4753
Carine Bellera
- Fonction : Auteur
- PersonId : 769480
- ORCID : 0000-0001-7926-4671
- IdRef : 203945417
Résumé
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.