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

被引：128

作者：

Platzbecker, U. ^{[1
,2
]}

Fenaux, P. ^{[2
,3
,4
]}

Ades, L. ^{[2
,3
,4
]}

Giagounidis, A. ^{[2
,5
]}

Santini, V. ^{[2
,6
]}

van de Loosdrecht, A. A. ^{[2
,7
]}

Bowen, D. ^{[8
]}

de Witte, T. ^{[9
]}

Garcia-Manero, G. ^{[10
]}

Hellstrom-Lindberg, E. ^{[11
]}

Germing, U. ^{[2
,12
]}

Stauder, R. ^{[13
]}

Malcovati, L. ^{[14
]}

Sekeres, Mikkael A. ^{[15
]}

Steensma, David P. ^{[16
]}

Gloaguen, S. ^{[2
]}

机构：

[1] Leipzig Univ Hosp, Med Clin & Policlin 1, Hematol & Cellular Therapy, Johannisallee 32 A, D-04103 Leipzig, Germany

[2] European Myelodysplast Syndromes Cooperat Grp EMS, Leipzig, Germany

[3] Hop St Louis, AP HP, Paris, France

[4] Univ Paris 07, Paris, France

[5] Marien Hosp, Klin Onkol Hamatol & Palliat Med, Dusseldorf, Germany

[6] Univ Florence, Azienda Osped Univ AOU Careggi, Florence, Italy

[7] Vrije Univ Amsterdam Med Ctr, Canc Ctr Amsterdam, Dept Haematol, Amsterdam, Netherlands

[8] Leeds Teaching Hosp, St Jamess Inst Oncol, Leeds, W Yorkshire, England

[9] Radboud Univ Nijmegen, Med Ctr, Nijmegen Ctr Mol Life Sci, Dept Tumor Immunol, Nijmegen, Netherlands

[10] Univ Texas MD Anderson Canc Ctr, Dept Leukemia, Houston, TX 77030 USA

[11] Karolinska Inst, Dept Med, Div Haematol, Stockholm, Sweden

[12] Univ Klin Dusseldorf, Dept Haematol Oncol & Clin Immunol, Dusseldorf, Germany

[13] Med Univ Innsbruck, Dept Internal Med Hematol & Oncol 5, Innsbruck, Austria

[14] Univ Pavia, Policlin San Matteo, Fdn Ist Ricovero & Cura Carattere Sci IRCCS, Dept Haematol Oncol, Pavia, Italy

[15] Cleveland Clin, Taussig Canc Inst, Leukemia Program, Cleveland, OH 44106 USA

[16] Dana Farber Canc Inst, Boston, MA 02115 USA

来源：

BLOOD | 2019年 / 133卷 / 10期

关键词：

QUALITY-OF-LIFE; PRIMARY MYELODYSPLASTIC SYNDROMES; INTERNATIONAL WORKING GROUP; REPORTED OUTCOMES; ANEMIC PATIENTS; EPOETIN-ALPHA; LOW-RISK; IMPACT; LENALIDOMIDE; PLACEBO;

D O I：

10.1182/blood-2018-06-857102

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：1020 / 1030

页数：11

共 29 条

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