Franck Bonnetain1, Bert Bonsing2, Thierry Conroy3, Adelaide Dousseau4, Bengt Glimelius5, Karin Haustermans6, François Lacaine7, Jean Luc Van Laethem8, Thomas Aparicio9, Daniela Aust10, Claudio Bassi11, Virginie Berger12, Emmanuel Chamorey13, Benoist Chibaudel14, Laeticia Dahan15, Aimery De Gramont14, Jean Robert Delpero16, Christos Dervenis17, Michel Ducreux18, Jocelyn Gal19, Erich Gerber20, Paula Ghaneh21, Pascal Hammel22, Alain Hendlisz23, Valérie Jooste24, Roberto Labianca25, Aurelien Latouche26, Manfred Lutz27, Teresa Macarulla28, David Malka18, Muriel Mauer29, Emmanuel Mitry30, John Neoptolemos31, Patrick Pessaux32, Alain Sauvanet33, Josep Tabernero28, Julien Taieb34, Geertjan van Tienhoven35, Sophie Gourgou-Bourgade36, Carine Bellera37, Simone Mathoulin-Pélissier37, Laurence Collette29. 1. Methodology and Quality of Life Unit in Cancer, EA 3181, University Hospital of Besançon and CTD-INCa Gercor, UNICNCER GERICO, Besançon, France. Electronic address: franck.bonnetain@univ-fcomte.fr. 2. Leiden University Medical Center, Leiden, Netherlands. 3. Department of Medical Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre-les-Nancy, France. 4. Bordeaux Segalen University & CHRU, Bordeaux, France. 5. Department of Radiology, Oncology and Radiation Science, Uppsala University, Uppsala, Sweden. 6. Department of Radiation Oncology, Leuven, Belgium. 7. Digestive Surgical Department, Tenon hospital, Paris, France. 8. Gastro Intestinal Cancer Unit Erasme Hospital Brussels, Belgium. 9. Gastroenterology Department, Avicenne Hospital, Paris 13, Bobigny, France. 10. Institute for Pathology, University Hospital Carl-Gustav-Carus, Dresden, Germany. 11. Surgical and Gastroenterological Department, Endocrine and Pancreatic Unit, Hospital of 'G.B.Rossi', University of Verona, Italy. 12. Institut de Cancérologie de l'Ouest - Centre Paul Papin Centre de Lutte Contre le Cancer (CLCC), Angers, France. 13. Biostatistics Unit, Centre Antoine Lacassagne, Nice, France. 14. Oncology Department, Hôpital Saint-Antoine & CTD-INCa GERCOR, Assistance Publique des Hôpitaux de Paris, UPMC Paris VI, Paris, France. 15. Gastroenterology Department, Hopital la Timone, Assitance publique des Hopitaux de Marseille, Marseille, France. 16. Department of Surgery, Institut Paoli Calmettes, Marseille, France. 17. Department of Surgery, Agia Olga Hospital, Athens, Greece. 18. Department of Gastroenterology, Institut Gustave Roussy, Villejuif, France. 19. Biostatistician, Biostatistics Unit, Centre Antoine Lacassagne, Nice, France. 20. Department of Radiotherapy, Institut fuer Radioonkologie, Vienna, Austria. 21. Department of Surgical Oncology, Royal Liverpool Hospital, United Kingdom. 22. Department of Gastroenterology, Beaujon Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France. 23. Digestive Oncology and Gastro-enterology Department, Jules Bordet Institute, Brussels, Belgium. 24. Digestive Cancer Registry, INSERM U866, Dijon, France. 25. Medical Oncology Unit, Ospedali Riuniti di Bergamo, Bergame, Italy. 26. Inserm, Centre for Research in Epidemiology and Population Health, U1018, Biostatistics Team, Villejuif, France. 27. Gastroenterology Department, Caritas Hospital, Saarbrücken, Germany. 28. Department of the Gastrointestinal Tumors and Phase I Unit, Vall d'Hebron University Hospital, Barcelona, Spain. 29. Statistics Department, EORTC, Brussels, Belgium. 30. Department of Medical Oncology, Institut Curie, Hôpital René Huguenin, Saint-Cloud, France. 31. Division of Surgery and Oncology at the University of Liverpool and Royal Liverpool University Hospital, Liverpool, United Kingdom. 32. Department of Digestive Surgery, Universitu Hospital Strasbourg, France. 33. Department of Hepato-pancreatic and Biliary Surgery, Beaujon Hospital, Assistance Publique des Hôpitaux de Paris, Paris, France. 34. Department of Hepato-gastroenterology and Digestive Oncology, Georges Pompidou European hospital, Paris, France. 35. Department of Radiation Oncology, Academisch Medisch Centrum, Amsterdam, The Netherlands. 36. Institut Du Cancer de Montpellier, Comprehensive Cancer Centre, and Data Center for Cancer Clinical Trials, CTD-INCa, Montpellier, France. 37. Clinical and Epidemiological Research Unit, Institut Bergonie, Comprehensive Cancer Centre, Bordeaux, France; Data Center for Cancer Clinical Trials, CTD-INCa, Bordeaux, France; INSERM, Centre d'Investigation Clinique - Épidémiologie Clinique CIC-EC 7, F-33000 Bordeaux, France.
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.
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.
Authors: Emil Ter Veer; L Bengt van Rijssen; Marc G Besselink; Rosa M A Mali; Jordan D Berlin; Stefan Boeck; Franck Bonnetain; Ian Chau; Thierry Conroy; Eric Van Cutsem; Gael Deplanque; Helmut Friess; Bengt Glimelius; David Goldstein; Richard Herrmann; Roberto Labianca; Jean-Luc Van Laethem; Teresa Macarulla; Jonathan H M van der Meer; John P Neoptolemos; Takuji Okusaka; Eileen M O'Reilly; Uwe Pelzer; Philip A Philip; Marcel J van der Poel; Michele Reni; Werner Scheithauer; Jens T Siveke; Chris Verslype; Olivier R Busch; Johanna W Wilmink; Martijn G H van Oijen; Hanneke W M van Laarhoven Journal: Lancet Oncol Date: 2018-03 Impact factor: 41.316
Authors: Momar Diouf; Thomas Filleron; Anne-Laure Pointet; Anne-Claire Dupont-Gossard; David Malka; Pascal Artru; Mélanie Gauthier; Thierry Lecomte; Thomas Aparicio; Anne Thirot-Bidault; Céline Lobry; Francine Fein; Olivier Dubreuil; Bruno Landi; Aziz Zaanan; Julien Taieb; Franck Bonnetain Journal: Qual Life Res Date: 2015-11-28 Impact factor: 4.147
Authors: Romain Cohen; Dewi Vernerey; Carine Bellera; Aurélia Meurisse; Julie Henriques; Xavier Paoletti; Benoît Rousseau; Steven Alberts; Thomas Aparicio; Ioannis Boukovinas; Sharlene Gill; Richard M Goldberg; Axel Grothey; Tetsuya Hamaguchi; Timothy Iveson; Rachel Kerr; Roberto Labianca; Sara Lonardi; Jeffrey Meyerhardt; James Paul; Cornelis J A Punt; Leonard Saltz; Marck P Saunders; Hans-Joachim Schmoll; Manish Shah; Alberto Sobrero; Ioannis Souglakos; Julien Taieb; Atsuo Takashima; Anna Dorothea Wagner; Marc Ychou; Franck Bonnetain; Sophie Gourgou; Takayuki Yoshino; Greg Yothers; Aimery de Gramont; Qian Shi; Thierry André Journal: Eur J Cancer Date: 2020-03-12 Impact factor: 9.162