TY - JOUR
T1 - Proposals for revised IWG 2018 hematological response criteria in patients with MDS included in clinical trials
AU - Platzbecker, U.
AU - Fenaux, P.
AU - Adès, L.
AU - Giagounidis, A.
AU - Santini, V.
AU - van de Loosdrecht, A. A.
AU - Bowen, D.
AU - de Witte, T.
AU - Garcia-Manero, G.
AU - Hellström-Lindberg, E.
AU - Germing, U.
AU - Stauder, R.
AU - Malcovati, L.
AU - Sekeres, Mikkael A.
AU - Steensma, David P.
AU - Gloaguen, S.
N1 - Funding Information:
Conflict-of-interest disclosure: U.P. and P.F. have received renumeration and research funding from Celgene Corporation. The remaining authors declare no competing financial interests.
Publisher Copyright:
© 2019 by The American Society of Hematology
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2019/3/7
Y1 - 2019/3/7
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85061150119
U2 - 10.1182/blood-2018-06-857102
DO - 10.1182/blood-2018-06-857102
M3 - Article
C2 - 30404811
SN - 0006-4971
VL - 133
SP - 1020
EP - 1030
JO - Blood
JF - Blood
IS - 10
ER -