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. 2015 Jun;21(6):984-99.
doi: 10.1016/j.bbmt.2015.02.025. Epub 2015 Mar 19.

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

Stephanie J Lee  1 , Daniel Wolff  2 , Carrie Kitko  3 , John Koreth  4 , Yoshihiro Inamoto  5 , Madan Jagasia  6 , Joseph Pidala  7 , Attilio Olivieri  8 , Paul J Martin  1 , Donna Przepiorka  9 , Iskra Pusic  10 , Fiona Dignan  11 , Sandra A Mitchell  12 , Anita Lawitschka  13 , David Jacobsohn  14 , Anne M Hall  1 , Mary E D Flowers  1 , Kirk R Schultz  15 , Georgia Vogelsang  16 , Steven Pavletic  17
Affiliations

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

Stephanie J Lee et al. Biol Blood Marrow Transplant. 2015 Jun.

Abstract

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.

Keywords: Allogeneic hematopoietic cell transplantation; Chronic graft-versus-host disease; Consensus; Guidelines; Response criteria.

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