Dataset Information

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

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.

SUBMITTER: Cohen R

PROVIDER: S-EPMC7409551 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Cohen Romain R Vernerey Dewi D Bellera Carine C Meurisse Aurélia A Henriques Julie J Paoletti Xavier X Rousseau Benoît B Alberts Steven S Aparicio Thomas T Boukovinas Ioannis I Gill Sharlene S Goldberg Richard M RM Grothey Axel A Hamaguchi Tetsuya T Iveson Timothy T Kerr Rachel R Labianca Roberto R Lonardi Sara S Meyerhardt Jeffrey J Paul James J Punt Cornelis J A CJA Saltz Leonard L Saunders Marck P MP Schmoll Hans-Joachim HJ Shah Manish M Sobrero Alberto A Souglakos Ioannis I Taieb Julien J Takashima Atsuo A Wagner Anna Dorothea AD Ychou Marc M Bonnetain Franck F Gourgou Sophie S Yoshino Takayuki T Yothers Greg G de Gramont Aimery A Shi Qian Q André Thierry T

European journal of cancer (Oxford, England : 1990) 20200312

<h4>Background</h4>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.<h4>Methods</h4>We performed a literature review to identify TTE end-points and events included in their definition in RCT public ...[more]

PMID: 32172199

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Dataset Information

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

Background

Methods

Results

Conclusion

Publications

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

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