title: 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.
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.
authors.affiliation: Department of Hematology and Oncology, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Madan H
authors.initials: MH
authors.lastname: Jagasia
authors.affiliation: Department of Internal Medicine, Medical University of Vienna, Vienna, Austria.
authors.forename: Hildegard T
authors.initials: HT
authors.lastname: Greinix
authors.affiliation: Department of Medicine, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Mukta
authors.initials: M
authors.lastname: Arora
authors.affiliation: Center for Cancer Research National Cancer Institute, National Institutes of Health, Bethesda, Maryland; Department of Blood and Marrow Transplantation, Children's National Health System, Washington, District of Columbia.
authors.forename: Kirsten M
authors.initials: KM
authors.lastname: Williams
authors.affiliation: Department of Internal Medicine, University of Regensburg, Regensburg, Germany.
authors.forename: Daniel
authors.initials: D
authors.lastname: Wolff
authors.affiliation: Center for Cancer Research National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Edward W
authors.initials: EW
authors.lastname: Cowen
authors.affiliation: Department of Hematology Oncology/Blood and Marrow Transplant, Mayo Clinic Arizona, Phoenix, Arizona.
authors.forename: Jeanne
authors.initials: J
authors.lastname: Palmer
authors.affiliation: Department of Medicine, University of Minnesota, Minneapolis, Minnesota.
authors.forename: Daniel
authors.initials: D
authors.lastname: Weisdorf
authors.affiliation: Department of Surgery, Division of Oral Medicine and Dentistry, Brigham and Women's Hospital, Boston, Massachusetts.
authors.forename: Nathaniel S
authors.initials: NS
authors.lastname: Treister
authors.affiliation: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: Guang-Shing
authors.initials: GS
authors.lastname: Cheng
authors.affiliation: Hematology Department, BC Cancer Agency, Vancouver, British Columbia, Canada.
authors.forename: Holly
authors.initials: H
authors.lastname: Kerr
authors.affiliation: Pediatric and Reproductive Endocrinology Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.
authors.forename: Pamela
authors.initials: P
authors.lastname: Stratton
authors.affiliation: Department of Hematology, Institut Catala d'Oncologia, Barcelona, Spain.
authors.forename: Rafael F
authors.initials: RF
authors.lastname: Duarte
authors.affiliation: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: George B
authors.initials: GB
authors.lastname: McDonald
authors.affiliation: Division of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Inamoto
authors.affiliation: Hematology and Hemotherapy Center, Hemocentro Unicamp, Campinas, Sao Paulo, Brazil.
authors.forename: Afonso
authors.initials: A
authors.lastname: Vigorito
authors.affiliation: Department of Blood and Marrow Transplantation, Stanford University Medical Center, Stanford, California.
authors.forename: Sally
authors.initials: S
authors.lastname: Arai
authors.affiliation: The Eye Clinic, National Eye Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Manuel B
authors.initials: MB
authors.lastname: Datiles
authors.affiliation: Department of Blood and Marrow Transplantation, Children's National Health System, Washington, District of Columbia.
authors.forename: David
authors.initials: D
authors.lastname: Jacobsohn
authors.affiliation: Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Disease, National Institutes of Health, Bethesda, Maryland.
authors.forename: Theo
authors.initials: T
authors.lastname: Heller
authors.affiliation: Blood and Marrow Transplant Program, University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan.
authors.forename: Carrie L
authors.initials: CL
authors.lastname: Kitko
authors.affiliation: Department of Applied Research Cancer Control and Population Sciences, National Institutes of Health, Bethesda, Maryland.
authors.forename: Sandra A
authors.initials: SA
authors.lastname: Mitchell
authors.affiliation: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Martin
authors.affiliation: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: Howard
authors.initials: H
authors.lastname: Shulman
authors.affiliation: Cancer Therapy Evaluation Program, National Institutes of Health, Bethesda, Maryland.
authors.forename: Roy S
authors.initials: RS
authors.lastname: Wu
authors.affiliation: Division of Hematologic Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
authors.forename: Corey S
authors.initials: CS
authors.lastname: Cutler
authors.affiliation: Oncology Department, Johns Hopkins University School of Medicine, Baltimore, Maryland.
authors.forename: Georgia B
authors.initials: GB
authors.lastname: Vogelsang
authors.affiliation: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors.forename: Stephanie J
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: Center for Cancer Research National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
authors.forename: Steven Z
authors.initials: SZ
authors.lastname: Pavletic
authors.affiliation: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington. Electronic address: mflowers@fredhutch.org.
authors.forename: Mary E D
authors.initials: ME
authors.lastname: Flowers
mesh_terms: D015415:Biomarkers; D002908:Chronic Disease; D002986:Clinical Trials as Topic / Q000379:methods* / Q000592:standards*; D032921:Consensus; D015975:Consensus Development Conferences, NIH as Topic; D005260:Female; D006086:Graft vs Host Disease / Q000175:diagnosis* / Q000378:metabolism / Q000628:therapy; D006801:Humans; D008297:Male; D009928:Organ Specificity; D017410:Practice Guidelines as Topic; D014481:United States
chemical_list: D015415:Biomarkers
keywords: Chronic graft-versus-host disease; Diagnosis; National Institutes of Health; Staging