title: 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.
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.
authors: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors: Stephanie J
authors: SJ
authors: Lee
authors: Department of Internal Medicine III, University of Regensburg, Regensburg, Germany.
authors: Daniel
authors: D
authors: Wolff
authors: Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
authors: Carrie
authors: C
authors: Kitko
authors: Division of Hematologic Malignancies, Dana Farber Cancer Institute, Boston, Massachusetts.
authors: John
authors: J
authors: Koreth
authors: Division of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.
authors: Yoshihiro
authors: Y
authors: Inamoto
authors: Division of Hematology-Oncology, Vanderbilt University, Nashville, Tennessee.
authors: Madan
authors: M
authors: Jagasia
authors: Blood and Marrow Transplantation, H. Lee Moffitt Cancer Center, Tampa, Florida.
authors: Joseph
authors: J
authors: Pidala
authors: Department of Clinical and Molecular Sciences, University of Ancona, Ancona, Italy.
authors: Attilio
authors: A
authors: Olivieri
authors: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors: Paul J
authors: PJ
authors: Martin
authors: US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland.
authors: Donna
authors: D
authors: Przepiorka
authors: Department of Medicine, Washington University, St. Louis, Missouri.
authors: Iskra
authors: I
authors: Pusic
authors: Department of Clinical Haematology, University of Manchester, Manchester, United Kingdom.
authors: Fiona
authors: F
authors: Dignan
authors: Outcomes Research Branch, National Cancer Institute, Bethesda, Maryland.
authors: Sandra A
authors: SA
authors: Mitchell
authors: Stem Cell Transplant Unit, St. Anna Children's Hospital, Medical University Vienna, Vienna, Austria.
authors: Anita
authors: A
authors: Lawitschka
authors: Division of Blood and Marrow Transplantation, Children's National Health System, Washington, District of Columbia.
authors: David
authors: D
authors: Jacobsohn
authors: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors: Anne M
authors: AM
authors: Hall
authors: Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
authors: Mary E D
authors: ME
authors: Flowers
authors: BC Children's Hospital, University of British Columbia, Vancouver, Canada.
authors: Kirk R
authors: KR
authors: Schultz
authors: Johns Hopkins Oncology Center, Baltimore, Maryland.
authors: Georgia
authors: G
authors: Vogelsang
authors: Outcomes Research Branch, National Cancer Institute, Bethesda, Maryland. Electronic address: pavletis@mail.nih.gov.
authors: Steven
authors: S
authors: Pavletic
mesh_terms: D000328:Adult; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D015415:Biomarkers / Q000032:analysis; D002648:Child; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D018450:Disease Progression; D006086:Graft vs Host Disease / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality / Q000473:pathology; D019337:Hematologic Neoplasms / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality / Q000473:pathology; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D009316:National Institutes of Health (U.S.); D012074:Remission Induction; D016019:Survival Analysis; D009626:Terminology as Topic; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D014481:United States
chemical_list: D000970:Antineoplastic Agents; D015415:Biomarkers; D007166:Immunosuppressive Agents
keywords: Allogeneic hematopoietic cell transplantation; Chronic graft-versus-host disease; Consensus; Guidelines; Response criteria