Core Outcome Measures in Effectiveness Trials

Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia

General Information

Abstract:
The myelodysplastic syndromes (MDSs) are heterogeneous with respect to clinical characteristics, pathologic features, and cytogenetic abnormalities. This heterogeneity is a challenge for evaluating response to treatment. Therapeutic trials in MDS have used various criteria to assess results, making cross-study comparisons problematic. In 2000, an International Working Group (IWG) proposed standardized response criteria for evaluating clinically significant responses in MDS. These criteria included measures of alteration in the natural history of disease, hematologic improvement, cytogenetic response, and improvement in health-related quality of life. The relevance of the response criteria has now been validated prospectively in MDS clinical trials, and they have gained acceptance in research studies and in clinical practice. Because limitations of the IWG criteria have surfaced, based on practical and reported experience, some modifications were warranted. In this report, we present recommendations for revisions of some of the initial criteria.

Authors:
Cheson, B. D. Greenberg, P. L. Bennett, J. M. Lowenberg, B. Wijermans, P. W. Nimer, S. D. Pinto, A. Beran, M. de Witte, T. M. Stone, R. M. Mittelman, M. Sanz, G. F. Gore, S. D. Schiffer, C. A. Kantarjian, H.

Publication

Journal:
Blood
Volume:
108
Issue:
2
Pages:
419 - 25
Year:
2006
DOI:
Further Study Information

Date:
Not stated
Funding source(s):

Health Area

Disease Category
Cancer

Disease Name
Myelodysplastic syndromes (MDS)

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Not specified

Method(s)

Unknown

Report from an International Working Group


Stakeholders Involved

Not Specified

Study Type

COS for clinical trials or clinical research

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