Measuring Therapeutic Response in Chronic Graft-versus-Host Disease. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2014 Response Criteria Working Group Report

被引：305

作者：

Lee, Stephanie J. ^{[1
]}

Wolff, Daniel ^{[2
]}

Kitko, Carrie ^{[3
]}

Koreth, John ^{[4
]}

Inamoto, Yoshihiro ^{[5
]}

Jagasia, Madan ^{[6
]}

Pidala, Joseph ^{[7
]}

Olivieri, Attilio ^{[8
]}

Martin, Paul J. ^{[1
]}

Przepiorka, Donna ^{[9
]}

Pusic, Iskra ^{[10
]}

Dignan, Fiona ^{[11
]}

Mitchell, Sandra A. ^{[12
]}

Lawitschka, Anita ^{[13
]}

Jacobsohn, David ^{[14
]}

Hall, Anne M. ^{[1
]}

Flowers, Mary E. D. ^{[1
]}

Schultz, Kirk R. ^{[15
]}

Vogelsang, Georgia ^{[16
]}

Pavletic, Steven ^{[12
]}

机构：

[1] Fred Hutchinson Canc Res Ctr, Div Clin Res, Seattle, WA 98104 USA

[2] Univ Regensburg, Dept Internal Med 3, D-93053 Regensburg, Germany

[3] Univ Michigan, Dept Pediat, Ann Arbor, MI 48109 USA

[4] Dana Farber Canc Inst, Div Hematol Malignancies, Boston, MA 02115 USA

[5] Natl Canc Ctr, Div Hematopoiet Stem Cell Transplantat, Tokyo, Japan

[6] Vanderbilt Univ, Div Hematol Oncol, Nashville, TN 37235 USA

[7] Univ S Florida, H Lee Moffitt Canc Ctr, Blood & Marrow Transplantat, Tampa, FL 33682 USA

[8] Univ Ancona, Dept Clin & Mol Sci, Ancona, Italy

[9] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[10] Washington Univ, Dept Med, St Louis, MO USA

[11] Univ Manchester, Dept Clin Haematol, Manchester, Lancs, England

[12] NCI, Outcomes Res Branch, Bethesda, MD 20852 USA

[13] Med Univ Vienna, St Anna Childrens Hosp, Stem Cell Transplant Unit, Vienna, Austria

[14] Childrens Natl Hlth Syst, Div Blood & Marrow Transplantat, Washington, DC USA

[15] Univ British Columbia, BC Childrens Hosp, Vancouver, BC V5Z 1M9, Canada

[16] Johns Hopkins Univ, Sch Med, Johns Hopkins Oncol Ctr, Baltimore, MD 21205 USA

来源：

BIOLOGY OF BLOOD AND MARROW TRANSPLANTATION | 2015年 / 21卷 / 06期

关键词：

Chronic graft-versus-host disease; Allogeneic hematopoietic cell transplantation; Response criteria; Consensus; Guidelines; STEM-CELL TRANSPLANTATION; SYSTEMIC-LUPUS-ERYTHEMATOSUS; BONE-MARROW-TRANSPLANTATION; CHRONIC GVHD CONSORTIUM; 6-MINUTE WALK TEST; OBLITERANS ORGANIZING PNEUMONIA; HUMAN ACTIVITY PROFILE; FAILURE-FREE SURVIVAL; SLEEP QUALITY INDEX; RHEUMATOID-ARTHRITIS;

D O I：

10.1016/j.bbmt.2015.02.025

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

In 2005, the National Institutes of Health (NIH) Chronic Graft-versus-Host Disease (GVHD) Consensus Response Criteria Working Group recommended several measures to document serial evaluations of chronic GVHD organ involvement. Provisional definitions of complete response, partial response, and progression were proposed for each organ and for overall outcome. Based on publications over the last 9 years, the 2014 Working Group has updated its recommendations for measures and interpretation of organ and overall responses. Major changes include elimination of several clinical parameters from the determination of response, updates to or addition of new organ scales to assess response, and the recognition that progression excludes minimal, clinically insignificant worsening that does not usually warrant a change in therapy. The response definitions have been revised to reflect these changes and are expected to enhance reliability and practical utility of these measures in clinical trials. Clarification is provided about response assessment after the addition of topical or organ-targeted treatment. Ancillary measures are strongly encouraged in clinical trials. Areas suggested for additional research include criteria to identify irreversible organ damage and validation of the modified response criteria, including in the pediatric population. Published by Elsevier Inc.

引用

页码：984 / 999

页数：16

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