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Blood, 1 December 2000, Vol. 96, No. 12, pp. 3671-3674
PERSPECTIVE
Report of an international working group to standardize response
criteria for myelodysplastic syndromes
Bruce D. Cheson,
John M. Bennett,
Hagop Kantarjian,
Antonio Pinto,
Charles A. Schiffer,
Stephen D. Nimer,
Bob Löwenberg,
Miroslav Beran,
Theo M. de Witte,
Richard M. Stone,
Moshe Mittelman,
Guillermo F. Sanz,
Pierre W. Wijermans,
Steven Gore, and
Peter L. Greenberg
From the National Cancer Institute, Bethesda, MD;
University of Rochester Cancer Center, Rochester, NY; MD Anderson
Cancer Center, University of Texas, Houston, TX; Centro di Riferimento
Oncologico, Aviano, Italy; Karmanos Cancer Center, Wayne State
University, Detroit, MI; Memorial Sloan-Kettering Cancer Center, New
York, NY; University Hospital, Rotterdam, The Netherlands; University
Hospital Nijmegen, Rijmegen, The Netherlands; Dana Farber Cancer
Institute, Boston, MA; Rabin Medical Center-Hasharon Hospital,
Petah-Tikva Tel-Aviv University, Tel-Aviv, Israel; Hospital
Universitario La Fe, Valencia, Spain; Ziekenhuis, Leyenburg,
The Hague, The Netherlands; Johns Hopkins Oncology Center, Baltimore,
MD; Stanford University Medical Center and Veterans Administration
Hospital, Palo Alto, CA.
Standardized criteria for assessing response are essential to
ensure comparability among clinical trials for patients with myelodysplastic syndromes (MDS). An international working group of
experienced clinicians involved in the management of patients with MDS
reviewed currently used response definitions and developed a uniform
set of guidelines for future clinical trials in MDS. The MDS differ
from many other hematologic malignancies in their chronicity and the
morbidity and mortality caused by chronic cytopenias, often without
disease progression to acute myeloid leukemia. Whereas response rates
may be an important endpoint for phase 2 studies of new agents and may
assist regulatory agencies in their evaluation and approval processes,
an important goal of clinical trials in MDS should be to prolong
patient survival. Therefore, these response criteria reflected 2 sets
of goals in MDS: altering the natural history of the disease and
alleviating disease-related complications with improved quality of
life. It is anticipated that the recommendations presented will require
modification as more is learned about the molecular biology and
genetics of these disorders. Until then, it is hoped these guidelines
will serve to improve communication among investigators and to ensure
comparability among clinical trials.
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M. B. Steins, T. Padro, R. Bieker, S. Ruiz, M. Kropff, J. Kienast, T. Kessler, T. Buechner, W. E. Berdel, and R. M. Mesters
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Blood,
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[Abstract]
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P. L. Greenberg, N. S. Young, and N. Gattermann
Myelodysplastic Syndromes
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[Abstract]
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B. D. Cheson, J. M. Bennett, H. Kantarjian, C. A. Schiffer, S. D. Nimer, B. Lowenberg, R. M. Stone, M. Mittelman, G. F. Sanz, P. W. Wijermans, et al.
Myelodysplastic syndromes standardized response criteria: further definition
Blood,
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A. Raza, P. Meyer, D. Dutt, F. Zorat, L. Lisak, F. Nascimben, M. du Randt, C. Kaspar, C. Goldberg, J. Loew, et al.
Thalidomide produces transfusion independence in long-standing refractory anemias of patients with myelodysplastic syndromes
Blood,
August 15, 2001;
98(4):
958 - 965.
[Abstract]
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A. Raza
Improve or abandon the standardized response criteria for myelodysplastic syndromes recommended by the International Working Group
Blood,
July 1, 2001;
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D. P. Steensma, L. Letendre, A. Tefferi, B. D. Cheson, J. M. Bennett, and P. L. Greenberg
Clarifications to the standard neutrophil response criteria for clinical trials in myelodysplastic syndromes are needed
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