Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)dagger
| Autor: | Roger A'Hern, Stefan Michiels, Robert E. Coleman, D. Azria, F. Bonnetain, Gaëtan MacGrogan, Henri Roché, William Jacot, Carine Bellera, Bernard Asselain, David Cameron, Simone Mathoulin-Pélissier, Tanja Cufer, Michael Untch, Hans Wildiers, I. Negreiros, V. Servent, F. Penault Llorca, Suzette Delaloge, G. van Tienhoven, Thomas Filleron, Marc Debled, John Yarnold, Hervé Bonnefoi, P.M. Poortmans, Fernando Schmitt, Nicola S. Russell, Birgitte Vrou Offersen, Judith M Bliss, Joseph Gligorov, Etienne Brain, Florence Dalenc, Fatima Cardoso, E. de Azambuja, Maciej Gutowski, Jan Bogaerts, Sophie Gourgou-Bourgade, L. Dal Lago, Maria João Cardoso, T. S. Dabakuyo-yonli, C. Kirkove, Benoist Chibaudel, J.A. van der Hage, Giancarlo Pruneri, Beat Thürlimann |
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| Přispěvatelé: | Institut du Cancer de Montpellier (ICM), University of Edinburgh, Radiation Oncology Department, Dr. B. Verbeeten Institute, Institut Curie [Paris], CRLCC Val d'Aurelle - Paul Lamarque, Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), European School of Oncology & Breast Unit, Champalimaud Clinical Center, Lisbon, Portugal, Champalimaud Clinical Center, The institute of cancer research [London], European Organisation for Research and Treatment of Cancer [Bruxelles] (EORTC), European Cancer Organisation [Bruxelles] (ECCO), Institut Bergonié [Bordeaux], UNICANCER, Hôpital René HUGUENIN (Saint-Cloud), CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Pathologie mammaire, Département de médecine oncologique [Gustave Roussy], Institut Gustave Roussy (IGR)-Institut Gustave Roussy (IGR), Institut Jules Bordet [Bruxelles], Faculté de Médecine [Bruxelles] (ULB), Université libre de Bruxelles (ULB)-Université libre de Bruxelles (ULB), Institut Claudius Regaud, Institut Gustave Roussy (IGR), Service de biostatistique et d'épidémiologie (SBE), Direction de la recherche clinique [Gustave Roussy], CHU Tenon [AP-HP], CRLC Val d'Aurelle-Paul Lamarque, Département de pathologie, UNICANCER-UNICANCER, Equipe de recherche sur les traitements individualisés des cancers (ERTICa), Université d'Auvergne - Clermont-Ferrand I (UdA), Division of Pathology, European Institute of Oncology [Milan] (ESMO), Institut de Recherche sur la Fusion par confinement Magnétique (IRFM), Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Unité de neurophysiologie [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), UCL - SSS/IREC - Institut de recherche expérimentale et clinique, UCL - (SLuc) Service de radiothérapie oncologique |
| Rok vydání: | 2015 |
| Předmět: |
Oncology
Research design Time Factors Delphi Technique Event (relativity) Delphi method law.invention 0302 clinical medicine Randomized controlled trial law Medicine Treatment Failure guidelines Randomized Controlled Trials as Topic 0303 health sciences Hematology Women's cancers Radboud Institute for Health Sciences [Radboudumc 17] 3. Good health Research Design 030220 oncology & carcinogenesis Disease Progression Female medicine.medical_specialty Consensus Endpoint Determination Comparative effectiveness research MEDLINE Breast Neoplasms [SDV.CAN]Life Sciences [q-bio]/Cancer Disease-Free Survival 03 medical and health sciences Breast cancer breast cancer Terminology as Topic Internal medicine Humans Medical physics time-to-event end point 030304 developmental biology End point Surrogate endpoint business.industry efficacy measure Cancer controlled trial medicine.disease Clinical trial randomized [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie business |
| Zdroj: | Annals of Oncology, 26, 873-879 Annals of Oncology Annals of Oncology, 2015, 26 (5), pp.873-879. ⟨10.1093/annonc/mdv106⟩ Gourgou-Bourgade, S, Cameron, D, Poortmans, P, Asselain, B, Azria, D, Cardoso, F, A'Hern, R, Bliss, J, Bogaerts, J, Bonnefoi, H, Brain, E, Cardoso, M J, Chibaudel, B, Coleman, R, Cufer, T, Dal Lago, L, Dalenc, F, De Azambuja, E, Debled, M, Delaloge, S, Filleron, T, Gligorov, J, Gutowski, M, Jacot, W, Kirkove, C, MacGrogan, G, Michiels, S, Negreiros, I, Offersen, B V, Penault Llorca, F, Pruneri, G, Roche, H, Russell, N S, Schmitt, F, Servent, V, Thürlimann, B, Untch, M, van der Hage, J A, van Tienhoven, G, Wildiers, H, Yarnold, J, Bonnetain, F, Mathoulin-Pélissier, S, Bellera, C & Dabakuyo-Yonli, T S 2015, ' Guidelines for time-to-event end point definitions in breast cancer trials: results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) ', Annals of Oncology, vol. 26, no. 12, pp. 2505-6 . https://doi.org/10.1093/annonc/mdv478 Annals of Oncology, Elsevier, 2015, 26 (5), pp.873-879. ⟨10.1093/annonc/mdv106⟩ Annals of Oncology, 26, 5, pp. 873-879 Annals of Oncology, Vol. 26, no.5, p. 873-879 (2015) |
| ISSN: | 0923-7534 1569-8041 |
| Popis: | Item does not contain fulltext BACKGROUND: Using surrogate end points for overall survival, such as disease-free survival, is increasingly common in randomized controlled trials. However, the definitions of several of these time-to-event (TTE) end points are imprecisely which limits interpretation and cross-trial comparisons. The estimation of treatment effects may be directly affected by the definitions of end points. The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for randomized cancer clinical trials (RCTs) in breast cancer. PATIENTS AND METHODS: A literature review was carried out to identify TTE end points (primary or secondary) reported in publications of randomized trials or guidelines. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points based on a validated consensus method that formalize the degree of agreement among experts. RESULTS: Recommended guidelines for the definitions of TTE end points commonly used in RCTs for breast cancer are provided for non-metastatic and metastatic settings. CONCLUSION: The use of standardized definitions should facilitate comparisons of trial results and improve the quality of trial design and reporting. These guidelines could be of particular interest to those involved in the design, conducting, reporting, or assessment of RCT. |
| Databáze: | OpenAIRE |
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