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

U. Platzbecker, P. Fenaux, L. Adès, A. Giagounidis, V. Santini, A. A. van de Loosdrecht, D. Bowen, T. de Witte, G. Garcia-Manero, E. Hellström-Lindberg, U. Germing, R. Stauder, L. Malcovati, Mikkael A. Sekeres, David P. Steensma, S. Gloaguen

Research output: Contribution to journalArticle

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.
Original languageEnglish
JournalBlood
Volume133
Issue number10
DOIs
Publication statusPublished - Mar 7 2019

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Myelodysplastic Syndromes
Clinical Trials
Therapeutics

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Platzbecker, U., Fenaux, P., Adès, L., Giagounidis, A., Santini, V., van de Loosdrecht, A. A., ... Gloaguen, S. (2019). Proposals for revised IWG 2018 hematological response criteria in patients with MDS included in clinical trials. Blood, 133(10). https://doi.org/10.1182/blood-2018-06-857102

Proposals for revised IWG 2018 hematological response criteria in patients with MDS included in clinical trials. / Platzbecker, U.; Fenaux, P.; Adès, L.; Giagounidis, A.; Santini, V.; van de Loosdrecht, A. A.; Bowen, D.; de Witte, T.; Garcia-Manero, G.; Hellström-Lindberg, E.; Germing, U.; Stauder, R.; Malcovati, L.; Sekeres, Mikkael A.; Steensma, David P.; Gloaguen, S.

In: Blood, Vol. 133, No. 10, 07.03.2019.

Research output: Contribution to journalArticle

Platzbecker, U, Fenaux, P, Adès, L, Giagounidis, A, Santini, V, van de Loosdrecht, AA, Bowen, D, de Witte, T, Garcia-Manero, G, Hellström-Lindberg, E, Germing, U, Stauder, R, Malcovati, L, Sekeres, MA, Steensma, DP & Gloaguen, S 2019, 'Proposals for revised IWG 2018 hematological response criteria in patients with MDS included in clinical trials', Blood, vol. 133, no. 10. https://doi.org/10.1182/blood-2018-06-857102
Platzbecker U, Fenaux P, Adès L, Giagounidis A, Santini V, van de Loosdrecht AA et al. Proposals for revised IWG 2018 hematological response criteria in patients with MDS included in clinical trials. Blood. 2019 Mar 7;133(10). https://doi.org/10.1182/blood-2018-06-857102
Platzbecker, U. ; Fenaux, P. ; Adès, L. ; Giagounidis, A. ; Santini, V. ; van de Loosdrecht, A. A. ; Bowen, D. ; de Witte, T. ; Garcia-Manero, G. ; Hellström-Lindberg, E. ; Germing, U. ; Stauder, R. ; Malcovati, L. ; Sekeres, Mikkael A. ; Steensma, David P. ; Gloaguen, S. / Proposals for revised IWG 2018 hematological response criteria in patients with MDS included in clinical trials. In: Blood. 2019 ; Vol. 133, No. 10.
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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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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.

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