National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group Report

Madan H. Jagasia, Hildegard T. Greinix, Mukta Arora, Kirsten M. Williams, Daniel Wolff, Edward W. Cowen, Jeanne Palmer, Daniel Weisdorf, Nathaniel S. Treister, Guang Shing Cheng, Holly Kerr, Pamela Stratton, Rafael F. Duarte, George B. McDonald, Yoshihiro Inamoto, Afonso Vigorito, Sally Arai, Manuel B. Datiles, David Jacobsohn, Theo HellerCarrie L. Kitko, Sandra A. Mitchell, Paul J. Martin, Howard Shulman, Roy S. Wu, Corey S. Cutler, Georgia B. Vogelsang, Stephanie J. Lee, Steven Z. Pavletic, Mary E D Flowers

Research output: Contribution to journalArticlepeer-review

731 Scopus citations

Abstract

The 2005 National Institutes of Health (NIH) Consensus Conference proposed new criteria for diagnosing and scoring the severity of chronic graft-versus-host disease (GVHD). The 2014 NIH consensus maintains the framework of the prior consensus with further refinement based on new evidence. Revisions have been made to address areas of controversy or confusion, such as the overlap chronic GVHD subcategory and the distinction between active disease and past tissue damage. Diagnostic criteria for involvement of mouth, eyes, genitalia, and lungs have been revised. Categories of chronic GVHD should be defined in ways that indicate prognosis, guide treatment, and define eligibility for clinical trials. Revisions have been made to focus attention on the causes of organ-specific abnormalities. Attribution of organ-specific abnormalities to chronic GVHD has been addressed. This paradigm shift provides greater specificity and more accurately measures the global burden of disease attributed to GVHD, and it will facilitate biomarker association studies.

Original languageEnglish (US)
Pages (from-to)389-401.e1
JournalBiology of Blood and Marrow Transplantation
Volume21
Issue number3
DOIs
StatePublished - Mar 1 2015

Bibliographical note

Funding Information:
This project was supported by the NIH's National Cancer Institute , Center for Cancer Research , Intramural Research Program and Division of Cancer Treatment and Diagnosis , Cancer Therapy Evaluation Program ; Office of Rare Disease Research, National Center for Advancing Translational Sciences ; Eunice Kennedy Shriver National Institute of Child Health and Human Development ; Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases ; National Heart, Lung, and Blood Institute , Division of Blood Diseases and Resources. This work was also supported in part by grants CA18029 and CA118953 from the National Cancer Institute and the National Institutes of Health . The authors want to acknowledge the following individuals and organizations that, by their participation, made this project possible: American Society for Blood and Marrow Transplantation, Center for International Bone and Marrow Transplant Research, US Chronic GVHD Consortium (supported by ORDR/NCATS and NCI), German-Austrian-Swiss chronic GVHD Consortium, National Marrow Donor Program, the Health Resources and Services Administration, Division of Transplantation, US Department of Human Health and Services, Canadian Blood and Marrow Transplant Group, European Group for Blood and Marrow Transplantation, Pediatric Blood and Marrow Transplant Consortium, and the representatives of the Brazilian Chronic GVHD consortium (Drs. Maria Claudia Moreira, Márcia de Matos Silva and Vaneuza Funke) and Deutsche José Carreras Leukämie-Stiftung. The authors would like to thank Dr. Joseph Antin (Dana Farber Cancer Center, Boston, MA) and Dr. Gerard Socie (University Paris VII & AP-HP, Hospital Saint Louis, Paris, France) for their critical review of the manuscript. The authors also thank Marcie Hall for careful review of the manuscript. The organizers are in debt to patients and patient and research advocacy groups, who made this process much more meaningful by their engagement. Acknowledgement goes to the Meredith Cowden GVHD foundation for facilitating the initial planning meeting in Cleveland in November of 2013 in conjunction with the National GVHD Symposium. The project group also recognizes the contributions of numerous colleagues in the field of blood and marrow transplantation in the US and internationally, medical specialists and consultants, the pharmaceutical industry, and the NIH and US Food and Drug Administration professional staff for their intellectual input, dedication, and enthusiasm on the road to completion of these documents. For their expert contributions to this 2014 NIH Consensus Diagnosis and Staging Working Group document special acknowledgements go to Drs. Mark Schubert, Fred Hutchinson Cancer Research Center in Seattle, WA, Tina Dietrich-Ntoukas, University of Regensburg, Germany, Janine Clayton, National Eye Institute, NIH, Bethesda, MD, Melissa A. Merideth, National Human Genome Research Institute, NIH, Bethesda, MD, Tajana Klepac Pulanic, Community Health Center East, Zagreb, Croatia, and Robert Knobler, University of Vienna, Austria.

Keywords

  • Chronic graft-versus-host disease
  • Diagnosis
  • National institutes of health
  • Staging

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