Guidelines for Time-to-Event End Point Definitions in Breast Cancer Trials Published by DATECAN Initiative

Guidelines for Time-to-Event End Point Definitions in Breast Cancer Trials Published by DATECAN Initiative
The Definition for the Assessment of Time-to-event Endpoints in CANcer trials (DATECAN initiative), recently published in the Annals of Oncology the guidelines for time-to-event end point definitions in breast cancer trials. In randomized cancer clinical trials (RCTs), the validated and most objectively defined evaluation criterion is overall survival (OS), characterized as the time from randomization to patients' death (all causes). However, the definition of several of these time-to-event (TTE) end points are inaccurate limiting the interpretation and cross-trial comparisons. The estimation of treatment effects may be directly affected by the definitions of end points Using a formal consensus process, statisticians and methodologists from UNICANCER under the leadership of the EORTC (European Organisation for Research and Treatment of Cancer) set up the international DATECAN initiative, which intends to obtain standardized consensus definitions of TTE end points for multiple cancer sites: breast; sarcomas/gastro intestinal stromal tumors (GISTs); pancreas; stomach/esophagus; head and neck; colon/rectum; kidney/bladder; and lung cancers. Prof. Franck Bonnetain noted in a recent news release, “DATECAN s
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