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 : Official Journal of the European Society for Medical Oncology
Sophie Gourgou-BourgadeDefinition for the Assessment of Time-to-event Endpoints in Cancer Trials Initiative

Abstract

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. 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. Recommended guidelines for the definitions of TTE end points commonly used in RCTs for breast cancer are provided for non-metastatic and metastatic settings. The use of standardized definitions should facilitate comparisons of trial results and improve the qual...Continue Reading

References

Mar 29, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·John R JohnsonRichard Pazdur
Dec 31, 2005·The New England Journal of Medicine·UNKNOWN Breast International Group (BIG) 1-98 Collaborative GroupAron Goldhirsch
Jan 24, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Bruce D ChesonUNKNOWN International Harmonization Project on Lymphoma
May 22, 2007·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Clifford A HudisJo Anne Zujewski
Jun 29, 2007·Journal of the National Cancer Institute·Cornelis J A PuntJean-Yves Douillard
May 15, 2008·Journal of the National Cancer Institute·Josep M LlovetUNKNOWN Panel of Experts in HCC-Design Clinical Trials
Aug 2, 2008·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Simone Mathoulin-PelissierAndrew Kramar
Mar 26, 2010·Annals of Internal Medicine·Kenneth F SchulzUNKNOWN CONSORT Group
Apr 7, 2010·Journal des maladies vasculaires·UNKNOWN Haute Autorité de Santé
Nov 6, 2012·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·Carine A BelleraFranck Bonnetain

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Citations

Sep 16, 2015·Annals of Oncology : Official Journal of the European Society for Medical Oncology·A KramarUNKNOWN DATECAN Renal Cancer group
Apr 24, 2016·British Journal of Anaesthesia·P S MylesUNKNOWN COMPAC-StEP Group
Sep 3, 2016·Journal of Cancer Research and Clinical Oncology·Seung Yeon SongEun Young Kim
Dec 13, 2016·Expert Review of Anticancer Therapy·Frédéric FiteniFranck Bonnetain
Nov 29, 2017·International Journal of Cancer. Journal International Du Cancer·Mathilde HisLaure Dossus
Mar 16, 2018·Cancer Research and Treatment : Official Journal of Korean Cancer Association·Ling DengHong Zheng
Sep 14, 2018·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Andrew D SeidmanLarissa A Korde
Jan 17, 2019·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Sherene LoiStefan Michiels
Jan 19, 2019·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M V DieciV Guarneri
Mar 26, 2019·The British Journal of Surgery·I G M PoodtUNKNOWN Sentinel Node and Recurrent Breast Cancer (SNARB) study group
Jun 4, 2020·Tumour Biology : the Journal of the International Society for Oncodevelopmental Biology and Medicine·A IanzaD Generali
Jun 23, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Barbara PistilliInes Vaz-Luis
Jul 10, 2020·Cancer Investigation·Bruno Luís de Castro AraujoLuiz Claudio Santos Thuler
Jul 17, 2020·Journal of Medical Economics·Stephen P McKenna, Alice Heaney
Apr 24, 2016·International Journal of Cancer. Journal International Du Cancer·Mathilde HisLaure Dossus
Jan 29, 2020·Histopathology·Tatiana GeorgieshBodil Bjerkehagen
Mar 28, 2020·JCO Clinical Cancer Informatics·Chiara NicolòSébastien Benzekry
May 23, 2018·BMC Cancer·Michael T ZimmermannJean-Pierre A Kocher
Sep 29, 2019·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Martin SjöströmPer Karlsson
Jan 27, 2021·Nature Reviews. Clinical Oncology·Jayant S VaidyaUNKNOWN TARGIT-A investigators
Feb 4, 2021·British Journal of Cancer·Jayant S VaidyaUNKNOWN TARGIT-A trial authors
Sep 9, 2019·HPB : the Official Journal of the International Hepato Pancreato Biliary Association·Eva RoosMarc G Besselink
Nov 7, 2020·Pharmaceutical Statistics·Michelle CaseyDaniel George
Oct 15, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Martine J PiccartUNKNOWN BIG-NABCG Collaboration
May 30, 2020·The Breast : Official Journal of the European Society of Mastology·Mami OgitaKeiichi Nakagawa

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