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    Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation. 2015 Mar 19. pii: S1083-8791(15)00155-X. doi: 10.1016/j.bbmt.2015.02.025
    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.
    Lee SJ1,  Wolff D2,  Kitko C3,  Koreth J4,  Inamoto Y5,  Jagasia M6,  Pidala J7,  Olivieri A8,  Martin PJ9,  Przepiorka D10,  Pusic I11,  Dignan F12,  Mitchell SA13,  Lawitschka A14,  Jacobsohn D15,  Hall AM16,  Flowers ME17,  Schultz KR18,  Vogelsang G19,  Pavletic S20
    Author information
    1Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
    2Department of Internal Medicine III, University of Regensburg, Regensburg, Germany.
    3Department of Pediatrics, University of Michigan, Ann Arbor, Michigan.
    4Division of Hematologic Malignancies, Dana Farber Cancer Institute, Boston, Massachusetts.
    5Division of Hematopoietic Stem Cell Transplantation, National Cancer Center Hospital, Tokyo, Japan.
    6Division of Hematology-Oncology, Vanderbilt University, Nashville, Tennessee.
    7Blood and Marrow Transplantation, H. Lee Moffitt Cancer Center, Tampa, Florida.
    8Department of Clinical and Molecular Sciences, University of Ancona, Ancona, Italy.
    9Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
    10US Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, Maryland.
    11Department of Medicine, Washington University, St. Louis, Missouri.
    12Department of Clinical Haematology, University of Manchester, Manchester, United Kingdom.
    13Outcomes Research Branch, National Cancer Institute, Bethesda, Maryland.
    14Stem Cell Transplant Unit, St. Anna Children's Hospital, Medical University Vienna, Vienna, Austria.
    15Division of Blood and Marrow Transplantation, Children's National Health System, Washington, District of Columbia.
    16Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
    17Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.
    18BC Children's Hospital, University of British Columbia, Vancouver, Canada.
    19Johns Hopkins Oncology Center, Baltimore, Maryland.
    20Outcomes Research Branch, National Cancer Institute, Bethesda, Maryland. Electronic address: pavletis@mail.nih.gov.
    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.


    Published by Elsevier Inc.

    KEYWORDS: Allogeneic hematopoietic cell transplantation, Chronic graft-versus-host disease, Consensus, Guidelines, Response criteria

    Publikations ID: 25796139
    Quelle: öffnen
     
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