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, Daniel Wolff, Carrie Kitko, John Koreth, Yoshihiro Inamoto, Madan Jagasia, Joseph Pidala, Attilio Olivieri, Paul J. Martin, Donna Przepiorka, Iskra Pusic, Fiona Dignan, Sandra A. Mitchell, Anita Lawitschka, David Jacobsohn, Anne M. Hall, Mary E.D. Flowers, Kirk R. Schultz, Georgia Vogelsang, Steven Pavletic

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)984-999
Number of pages16
JournalBiology of Blood and Marrow Transplantation
Volume21
Issue number6
DOIs
StatePublished - Jun 2015

Keywords

  • Allogeneic hematopoietic cell transplantation
  • Chronic graft-versus-host disease
  • Consensus
  • Guidelines
  • Response criteria

ASJC Scopus subject areas

  • Hematology
  • Transplantation

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    Lee, S. J., Wolff, D., Kitko, C., Koreth, J., Inamoto, Y., Jagasia, M., Pidala, J., Olivieri, A., Martin, P. J., Przepiorka, D., Pusic, I., Dignan, F., Mitchell, S. A., Lawitschka, A., Jacobsohn, D., Hall, A. M., Flowers, M. E. D., Schultz, K. R., Vogelsang, G., & Pavletic, S. (2015). 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. Biology of Blood and Marrow Transplantation, 21(6), 984-999. https://doi.org/10.1016/j.bbmt.2015.02.025