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Cohen R, Vernerey D, Bellera C, et al. Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative. Eur J Cancer. 2020;130:63-71doi: 10.1016/j.ejca.2020.02.009.
Cohen, R., Vernerey, D., Bellera, C., Meurisse, A., Henriques, J., Paoletti, X., Rousseau, B., Alberts, S., Aparicio, T., Boukovinas, I., Gill, S., Goldberg, R. M., Grothey, A., Hamaguchi, T., Iveson, T., Kerr, R., Labianca, R., Lonardi, S., Meyerhardt, J., Paul, J., Punt, C. J. A., Saltz, L., Saunders, M. P., Schmoll, H. J., Shah, M., Sobrero, A., Souglakos, I., Taieb, J., Takashima, A., Wagner, A. D., Ychou, M., Bonnetain, F., Gourgou, S., Yoshino, T., Yothers, G., de Gramont, A., Shi, Q., André, T. (2020). Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative. European journal of cancer (Oxford, England : 1990), 13063-71. https://doi.org/10.1016/j.ejca.2020.02.009
Cohen, Romain, et al. "Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative." European journal of cancer (Oxford, England : 1990) vol. 130 (2020): 63-71. doi: https://doi.org/10.1016/j.ejca.2020.02.009
Cohen R, Vernerey D, Bellera C, Meurisse A, Henriques J, Paoletti X, Rousseau B, Alberts S, Aparicio T, Boukovinas I, Gill S, Goldberg RM, Grothey A, Hamaguchi T, Iveson T, Kerr R, Labianca R, Lonardi S, Meyerhardt J, Paul J, Punt CJA, Saltz L, Saunders MP, Schmoll HJ, Shah M, Sobrero A, Souglakos I, Taieb J, Takashima A, Wagner AD, Ychou M, Bonnetain F, Gourgou S, Yoshino T, Yothers G, de Gramont A, Shi Q, André T. Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative. Eur J Cancer. 2020 May;130:63-71. doi: 10.1016/j.ejca.2020.02.009. Epub 2020 Mar 12. PMID: 32172199; PMCID: PMC7409551.
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Eur J Cancer. 2020 May;130:63-71. doi: 10.1016/j.ejca.2020.02.009. Epub 2020 Mar 12.

Guidelines for time-to-event end-point definitions in adjuvant randomised trials for patients with localised colon cancer: Results of the DATECAN initiative.

European journal of cancer (Oxford, England : 1990)

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,

Affiliations

  1. Sorbonne Université, Department of Medical Oncology, AP-HP, Hôpital Saint-Antoine, F-7512, Paris, France; Division of Biomedical Statistics and Informatics, Department of Health Science Research, Mayo Clinic, Rochester, MN, USA. Electronic address: [email protected].
  2. Methodology and Quality of Life Unit in Oncology, University Hospital of Besançon, F-25000, Besançon, France; University Bourgogne Franche-Comté, INSERM, EFS BFC, UMR1098, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, F-25000, Besançon, France.
  3. Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, Epicene Team, UMR 1219, F-33000 Bordeaux, France; Inserm CIC1401, Clinical and Epidemiological Research Unit, Institut Bergonié, Comprehensive Cancer Center, F-33000, Bordeaux, France.
  4. Université de Versailles-St Quentin & Institut Curie, INSERM U900, équipe Biostatistique, France.
  5. Memorial Sloan Kettering Cancer Center, New York, NY, USA.
  6. Department of Oncology, Mayo Clinic, Rochester, MN, USA.
  7. Service de Gastroentérologie et Cancérologie Digestive, Hôpital Saint Louis, APHP, Université de Paris, Paris, France.
  8. Bioclinic Oncology Unit of Thessaloniki, Thessaloniki, France.
  9. BC Cancer, Vancouver, Canada.
  10. West Virginia University Cancer Institute, Morgantown WV, USA.
  11. West Cancer Center and Research Institute, Germantown, TN, USA.
  12. Department of Gastroenterological Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
  13. University Hospital Southampton NHS Foundation Trust, Southampton, UK.
  14. Adjuvant Colorectal Cancer Group, University of Oxford, UK.
  15. Ospedale Papa Giovanni XXIII, Bergamo, Italy.
  16. Istituto Oncologico Veneto-IRCCS, Padova, Italy.
  17. Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, USA.
  18. Cancer Research UK Clinical Trials Unit (CTU), Institute of Cancer Sciences, University of Glasgow, UK.
  19. Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Netherlands.
  20. Department of Clinical Oncology, The Christie NHS Foundation Trust, Manchester, UK.
  21. EORTC GI Study Group, AIO Colorectal Cancer Group, Martin Luther University, Halle, Germany.
  22. Department of Medicine, Division of Hematology and Medical Oncology, Center for Advanced Digestive Care, Weill Cornell Medicine, New York-Presbyterian Hospital, New York, NY, USA.
  23. Medical Oncology Unit at Ospedale San Martino, Genova, Italy.
  24. Medical School, University of Crete, Heraklion, Greece.
  25. Sorbonne Paris Cité, Paris Descartes University, Department of Digestive Oncology, Georges Pompidou European Hospital, Paris, France.
  26. National Cancer Center Hospital, Tokyo, Japan.
  27. Department of Oncology, Lausanne University Hospital and University of Lausanne, Switzerland.
  28. Department of Medical Oncology, Institut Régional Du Cancer de Montpellier (ICM), France.
  29. Biometrics Unit, Montpellier Cancer Institute, Univ Montpellier, Montpellier, France.
  30. National Cancer Center Hospital East, Kashiwa, Japan.
  31. NRG Oncology and University of Pittsburgh, USA.
  32. Department of Medical Oncology, Institut Hospitalier Franco Britannique, Levallois-Perret, France.
  33. Division of Biomedical Statistics and Informatics, Department of Health Science Research, Mayo Clinic, Rochester, MN, USA.
  34. Sorbonne Université, Department of Medical Oncology, AP-HP, Hôpital Saint-Antoine, F-7512, Paris, France.

PMID: 32172199 PMCID: PMC7409551 DOI: 10.1016/j.ejca.2020.02.009

Abstract

BACKGROUND: The variability of definitions for time-to-event (TTE) end-points impacts the conclusions of randomised clinical trials (RCTs). The Definition for the Assessment of Time-to-event Endpoints in CANcer (DATECAN) initiative aims to provide consensus definitions for TTE end-points used in RCTs. Here, we formulate guidelines for adjuvant colon cancer RCTs.

METHODS: We performed a literature review to identify TTE end-points and events included in their definition in RCT publications. Then, a consensus was reached among a panel of international experts, using a formal modified Delphi method, with 2 rounds of questionnaires and an in-person meeting.

RESULTS: Twenty-four experts scored 72 events involved in 6 TTE end-points. Consensus was reached for 24%, 57% and 100% events after the first round, second round and in-person meeting. For RCTs not using overall survival as their primary end-point, the experts recommend using disease-free survival (DFS) rather than recurrence-free survival (RFS) or time to recurrence (TTR) as the primary end-point. The consensus definition of DFS includes all causes of death, second primary colorectal cancers (CRCs), anastomotic relapse and metastatic relapse as an event, but not second primary non-CRCs. Events included in the RFS definition are the same as for DFS with the exception of second primary CRCs. The consensus definition of TTR includes anastomotic or metastatic relapse, death with evidence of recurrence and death from CC cause.

CONCLUSION: Standardised definitions of TTE end-points ensure the reproducibility of the end-points between RCTs and facilitate cross-trial comparisons. These definitions should be integrated in standard practice for the design, reporting and interpretation of adjuvant CC RCTs.

Copyright © 2020 Elsevier Ltd. All rights reserved.

Keywords: Adjuvant; Chemotherapy; Colon cancer; Guidelines; Randomised controlled trials; Time-to-event end-points

Conflict of interest statement

Conflict of interest statement L.S. has received research funds from Taiho Pharmaceutical. M.S. has received honoraria for meetings/lectures from Roche, Merck, Sanofi, Servier and Amgen. R.C. has rece

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