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Dec 13, 2012 08:03AM
Dec 13, 2012 08:06AM
Back in 2007, distinguished Sloan Kettering physician Dr. Cliff Hudis outlined the problem in clinical trials of calculating endpoints with regard to treatments.....
Proposal for Standardized Definitions for Efficacy End
Points in Adjuvant Breast Cancer Trials: The STEEP System
Clifford A. Hudis, William E. Barlow, Joseph P. Costantino, Robert J. Gray, Kathleen I. Pritchard,
Judith-Anne W. Chapman, Joseph A. Sparano, Sally Hunsberger, Rebecca A. Enos, Richard D. Gelber,
and Jo Anne Zujewski
A B S T R A C T
Standardized definitions of breast cancer clinical trial end points must be adopted to permit the
consistent interpretation and analysis of breast cancer clinical trials and to facilitate cross-trial
comparisons and meta-analyses. Standardizing terms will allow for uniformity in data collection
across studies, which will optimize clinical trial utility and efficiency. A given end point term (eg,
overall survival) used in a breast cancer trial should always encompass the same set of events (eg,
death attributable to breast cancer, death attributable to cause other than breast cancer, death
from unknown cause), and, in turn, each event within that end point should be commonly defined
across end points and studies.
A panel of experts in breast cancer clinical trials representing medical oncology, biostatistics, and
correlative science convened to formulate standard definitions and address the confusion that
nonstandard definitions of widely used end point terms for a breast cancer clinical trial can
generate. We propose standard definitions for efficacy end points and events in early-stage
adjuvant breast cancer clinical trials. In some cases, it is expected that the standard end points
may not address a specific trial question, so that modified or customized end points would need
to be prospectively defined and consistently used.
The use of the proposed common end point definitions will facilitate interpretation of trial
outcomes. This approach may be adopted to develop standard outcome definitions for use in trials
involving other cancer sites.
J Clin Oncol 25:2127-2132. © 2007 by American Society of Clinical Oncology
When I read clinical trials, I am looking for disease free survival from the time of the COMPLETION of active treatment.
Doctor told me regarding my prognosis that I WASN'T on the Titanic! Hmmm...Really?....Okay! 02/2010 Pure Mucinous Breast Cancer, Oncotype DX 15, Stage 1, Grade 1, 1.8 cm, 0/2 nodes, ER+ 90% /PR+ 70% HER2- (+1)