Abstract
Background
Using potential surrogate end-points for overall survival (OS) such as Disease-Free-
(DFS) or Progression-Free Survival (PFS) is increasingly common in randomised controlled
trials (RCTs). However, end-points are too often imprecisely defined which largely
contributes to a lack of homogeneity across trials, hampering comparison between them.
The aim of the DATECAN (Definition for the Assessment of Time-to-event End-points
in CANcer trials)-Pancreas project is to provide guidelines for standardised definition
of time-to-event end-points in RCTs for pancreatic cancer.
Methods
Time-to-event end-points currently used were identified from a literature review of
pancreatic RCT trials (2006–2009). Academic research groups were contacted for participation
in order to select clinicians and methodologists to participate in the pilot and scoring
groups (>30 experts). A consensus was built after 2 rounds of the modified Delphi
formal consensus approach with the Rand scoring methodology (range: 1–9).
Results
For pancreatic cancer, 14 time to event end-points and 25 distinct event types applied
to two settings (detectable disease and/or no detectable disease) were considered
relevant and included in the questionnaire sent to 52 selected experts. Thirty experts
answered both scoring rounds. A total of 204 events distributed over the 14 end-points
were scored. After the first round, consensus was reached for 25 items; after the
second consensus was reached for 156 items; and after the face-to-face meeting for
203 items.
Conclusion
The formal consensus approach reached the elaboration of guidelines for standardised
definitions of time-to-event end-points allowing cross-comparison of RCTs in pancreatic
cancer.
Keywords
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Article info
Publication history
Published online: September 23, 2014
Accepted:
July 9,
2014
Received:
July 7,
2014
Footnotes
☆Results were presented as a poster communication at ASCO 2012; as oral communication as the World Congress of Gastro-intestinal Cancer Symposium 2012 and as oral communication at the 3rd Meeting of the COMET Initiative, June 2013.
Identification
Copyright
© 2014 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.
