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Blood. 2019 Mar 7;133(10):1020-1030. doi: 10.1182/blood-2018-06-857102. Epub 2018 Nov 7.

Proposals for revised IWG 2018 hematological response criteria in patients with MDS included in clinical trials.

Author information

1
Medical Clinic and Policlinic 1, Hematology and Cellular Therapy, Leipzig University Hospital, Leipzig, Germany.
2
European Myelodysplastic Syndromes Cooperative Group (EMSCO Group), Leipzig, Germany.
3
Hôpital Saint-Louis, Assistance Publique Hôpitaux de Paris, and Université Paris 7, Paris, France.
4
Klinik für Onkologie, Hämatologie und Palliativmedizin, Marien Hospital, Düsseldorf, Germany.
5
Azienda Ospedaliero Universitaria (AOU) Careggi, University of Florence, Florence, Italy.
6
Department of Haematology, Cancer Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands.
7
St. James's Institute of Oncology, Leeds Teaching Hospitals, Leeds, United Kingdom.
8
Department of Tumor Immunology, Nijmegen Center for Molecular Life Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
9
Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, TX.
10
Division of Haematology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden.
11
Department of Haematology, Oncology and Clinical Immunology, Universitätsklinik Düsseldorf, Düsseldorf, Germany.
12
Department of Internal Medicine V (Hematology and Oncology), Medical University Innsbruck, Innsbruck, Austria.
13
Department of Haematology Oncology, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Policlinico San Matteo, University of Pavia, Pavia, Italy.
14
Leukemia Program, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH; and.
15
Dana-Farber Cancer Institute, Boston, MA.

Abstract

The heterogeneity of myelodysplastic syndromes (MDSs) has made evaluating patient response to treatment challenging. In 2006, the International Working Group (IWG) proposed a revision to previously published standardized response criteria (IWG 2000) for uniformly evaluating clinical responses in MDSs. These IWG 2006 criteria have been used prospectively in many clinical trials in MDSs, but proved challenging in several of them, especially for the evaluation of erythroid response. In this report, we provide rationale for modifications (IWG 2018) of these recommendations, mainly for "hematological improvement" criteria used for lower-risk MDSs, based on recent practical and reported experience in clinical trials. Most suggestions relate to erythroid response assessment, which are refined in an overall more stringent manner. Two major proposed changes are the differentiation between "procedures" and "criteria" for hematologic improvement-erythroid assessment and a new categorization of transfusion-burden subgroups.

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