@article{1f6cd77b9ccb4fdc8a2362a0fdf73c4f,
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.",
keywords = "Allogeneic hematopoietic cell transplantation, Chronic graft-versus-host disease, Consensus, Guidelines, Response criteria",
author = "Lee, {Stephanie J.} and Daniel Wolff and Carrie Kitko and John Koreth and Yoshihiro Inamoto and Madan Jagasia and Joseph Pidala and Attilio Olivieri and Martin, {Paul J.} and Donna Przepiorka and Iskra Pusic and Fiona Dignan and Mitchell, {Sandra A.} and Anita Lawitschka and David Jacobsohn and Hall, {Anne M.} and Flowers, {Mary E.D.} and Schultz, {Kirk R.} and Georgia Vogelsang and Steven Pavletic",
note = "Funding Information: This project was supported by the National Institutes of Health (NIH) 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; Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Disease; National Heart Lung and Blood Institute, Division of Blood Diseases and Resources. The authors acknowledge the following individuals and organizations who, 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 Office of Rare Disease and National Cancer Institutes), German-Austrian-Swiss 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, Marcia and Vaneuza Funke), and Deutsche Jos{\'e} Carreras Leuk{\"a}mie-Stiftung. 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 United States 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 Response Criteria Working Group document special acknowledgements go to Drs. Edward Cowen, National Cancer Institute, NIH, Nathaniel Treister, Dana Farber Cancer Institute, Kirsten Williams, NIH and DC Children's National Medical Center, Pamela Stratton, National Institute of Child Health and Human Development, NIH, Tina Dietrich-Ntoukas, University of Regensburg, George McDonald and Mark Schubert, Fred Hutchinson Cancer Research Center, Carol Bassim, National Institute of Dental and Craniofacial Research, NIH, Janine Clayton, National Eye Institute, NIH, Gerhardt Hildebrandt, Huntsman Cancer Institute, Salt Lake City, Sharon Elad, University of Rochester, New York, Andrea Bacigalupo, University of Genoa, and Francis Ayuk, Universit{\"a}tsklinikum Hamburg-Eppendorf. Project participants also recognize Drs. Joseph Antin and Gerard Socie for their independent expert reviews and comments on final documents at the June 2014 meeting. Publisher Copyright: {\textcopyright} 2015 .",
year = "2015",
month = jun,
doi = "10.1016/j.bbmt.2015.02.025",
language = "English",
volume = "21",
pages = "984--999",
journal = "Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation",
issn = "1083-8791",
number = "6",
}