乳腺癌的临床试验终点事件的时间定义指南 —_2015

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© The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@. Guidelines for time-to-event endpoint definitions in Breast cancer trials: Results of the DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials)

S. Gourgou-Bourgade 1,*, D. Cameron², P. Poortmans 3, B. Asselain 4, D. Azria 5, F. Cardoso 6, R. A’Hern Roger 7, J. Bliss Judith 7, J. Bogaerts Jan 8, H. Bonnefoi Hervé9, E. Brain Etienne 10, M.J. Cardoso 6, B. Chibaudel 11, R. Coleman 12, T. Cufer 13, L. Dal Lago 14, F. Dalenc 15, E. De Azambuja 14, M. Debled 9, S. Delaloge 16, T. Filleron 15, J. Gligorov 17, M. Gutowski 18, W. Jacot 19, C. Kirkove 20, G. MacGrogan 9, S. Michiels 21,22, I. Negreiros Ida 23, B.V. Offersen 24, F. Penault Llorca 25,26, G. Pruneri 27,28, H. Roche 15, N.S. Russell 29, F. Schmitt 30,31, V. Servent 32, B. Thürlimann 33, M. Untch 34, J.A. van der Hage 35, G. van Tienhoven 36, H. Wildiers 37, J. Yarnold 38, F. Bonnetain 39, S. Mathoulin-Pélissier 40,41, C. Bellera 40,41, T.S. Dabakuyo-Yonli 42 1Biostatistic Unit, Montpellier Cancer Institute, Data Center for Cancer Clinical Trials, CTD-INCa, Montpellier, France

2Edinburgh Cancer Research Centre, University of Edinburgh, Western General Hospital, Edinburgh, United Kingdom

3Department of Radiation Oncology, Institute Verbeeten, Tilburg, The Netherlands

4Institut Curie, Paris France

5Department of radiation oncology, Montpellier Cancer Institute, Montpellier, France

6Breast Cancer Unit, Champalimaud Cancer Center Lisbon, Portugal

7Institute of Cancer Research, London, United Kingdom

8EORTC Data Center (European Organization of Research and Treatment of Cancer - Statistics department), Brussels Belgium

9Institut Bergonié, Comprehensive Cancer Centre, Bordeaux, France

10Departments of Clinical Research & Medical Oncology, Institut Curie - Hôpital René Huguenin Saint-Cloud, France

11Department of Medical Oncology - Hôpital Saint-Antoine - Paris, France

12FRCP, FRCPE YCR National Institute for Health Research Cancer Research Network (NCRN), Academic Unit of Clinical Oncology, Weston Park Hospital, Sheffield Cancer Research Centre Sheffield, United Kingdom

Annals of Oncology Advance Access published February 27, 2015 by guest on March 2, 2015

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13University Clinic Golnik, Slovenia

14Institut Jules Bordet, University « Libre » of Brussels, Brussels, Belgium

15Institut Claudius Régaud Toulouse, France

16Breast Cancer Group, Gustave Roussy Institute, Villejuif, France

17APHP Tenon – University Cancer Institute – Pierre & Marie Curie, Sorbonne University, Paris, France

18Department of surgery, Montpellier Cancer Institute, Montpellier, France

19Department of medical oncology, Montpellier Cancer Institute, Montpellier, France

20Université catholique Louvain, Belgium

21Gustave Roussy, Biostatistic and Epidemiology Unit, Villejuif, France

22University of Paris-Sud, Villejuif, France

23Breast Unit, Hospital CUF Descobertas, Lisbon, Portugal

24Department of Oncology, Aarhus University Hospital, Aarhus, Denmark

25Centre Jean Perrin, Clermont-Ferrand, France

26University of Clermont-Ferrand 1, ERTICA EA4677, UFR medicine, Clermont-Ferrand, France

27European Institute of Oncology, Milan, Italy

28University of Milan, School of Medicine, Milan, Italy

29Department of Radiotherapy, The Netherlands Cancer Institute - Antoni van Leeuwnhoek Hospital, Amsterdam, The Netherlands

30IPATIMUP (Institute of Molecular Pathology and Immunology of the University of Porto), Porto , Portugal

31Medical Faculty of Porto University, Porto, Portugal

32Oscar Lambret Comprehensive Cancer Center, Lille, France

33Kantonsspital St.Gallen, Breast Center ; St.Gallen, Switzerland

34Clinic for Gynecology, Gynecologic Oncology and Obstetrics- Interdisciplinary Breast Cancer Center, HELIOS Klinikum Berlin-Buch, Berlin, Germany

35Department of Surgical Oncology, The Netherlands Cancer Institute – Antoni van Leeuwenhoek Hospital Amsterdam, The Netherlands by guest on March 2, 2015 / Downloaded from