Abstract
Chronic graft-versus-host disease (GVHD) has been a difficult problem to address and clinical research in this area lags behind other innovations in hematopoietic stem cell transplantation (HCT). Recently the international transplant community has focused more on chronic GVHD. This new focus is well represented by the development of the National Institutes of Health sponsored chronic GVHD consensus project, which has unified the transplant community's approach to chronic GVHD through the activities of focused working groups. From December 2005 through May 2006, a series of consensus documents have been published addressing the areas of diagnosis and staging, histopathology, strategies for the development and validation of biomarkers, response criteria, ancillary therapy and supportive care and the design of clinical trials. This paper summarizes and discusses these reports, focusing specifically on diagnosis and scoring and response criteria. Although these documents represent a huge effort by the research community, they must be prospectively implemented and validated. These new criteria should advance the standards and uniformity of chronic GVHD clinical research. The ultimate success of this project is dependent on whether these recommendations move the field forward. This is an opportunity for the transplant community to unite and make a significant impact in chronic GVHD.
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References
Shulman HM, Sullivan KM, Weiden PL, McDonald GB, Striker GE, Sale GE et al. Chronic graft-versus-host syndrome in man. A long-term clinicopathologic study of 20 Seattle patients. Am J Med 1980; 69: 204–217.
Farag SS . Chronic graft-versus-host disease: where do we go from here? Bone Marrow Transplant 2004; 33: 569–577.
Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ et al. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant 2005; 11: 945–956.
Shulman HM, Kleiner D, Lee SJ, Morton T, Pavletic SZ, Farmer E et al. Histopathologic diagnosis of chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: II. Pathology Working Group Report. Biol Blood Marrow Transplant 2006; 12: 31–47.
Schultz KR, Miklos DB, Fowler D, Cooke K, Shizuru J, Zorn E et al. Toward biomarkers for chronic graft-versus-host disease: National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: III. Biomarker Working Group Report. Biol Blood Marrow Transplant 2006; 12: 126–137.
Pavletic SZ, Martin P, Lee SJ, Mitchell S, Jacobsohn D, Cowen EW et al. 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. Response Criteria Working Group report. Biol Blood Marrow Transplant 2006; 12: 252–266.
Couriel D, Carpenter PA, Cutler C, Bolanos-Meade J, Treister NS, Gea-Banacloche J et al. Ancillary therapy and supportive care of chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: V. Ancillary Therapy and Supportive Care Working Group Report. Biol Blood Marrow Transplant 2006; 12: 375–396.
Martin PJ, Weisdorf D, Przepiorka D, Hirschfeld S, Farrell A, Rizzo JD et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group report. Biol Blood Marrow Transplant 2006; 12: 491–505.
Socie G, Stone JV, Wingard JR, Weisdorf D, Henslee-Downey PJ, Bredeson C et al. Long-term survival and late deaths after allogeneic bone marrow transplantation. Late Effects Working Committee of the International Bone Marrow Transplant Registry. N Engl J Med 1999; 341: 14–21.
Lee SJ, Vogelsang G, Flowers ME . Chronic graft-versus-host disease. Biol Blood Marrow Transplant 2003; 9: 215–233.
Felson DT, Anderson JJ, Boers M, Bombardier C, Chernoff M, Fried B et al. The American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. The Committee on Outcome Measures in Rheumatoid Arthritis Clinical Trials. Arthritis Rheum 1993; 36: 729–740.
Ward MM, Marx AS, Barry NN . Comparison of the validity and sensitivity to change of 5 activity indices in systemic lupus erythematosus. J Rheumatol 2000; 27: 664–670.
Sandborn WJ, Feagan BG, Hanauer SB, Lochs H, Lofberg R, Modigliani R et al. A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn's disease. Gastroenterology 2002; 122: 512–530.
Rider LG, Giannini EH, Harris-Love M, Joe G, Isenberg D, Pilkington C et al. Defining Clinical Improvement in Adult and Juvenile Myositis. J Rheumatol 2003; 30: 603–617.
Lee S, Cook EF, Soiffer R, Antin JH . Development and validation of a scale to measure symptoms of chronic graft-versus-host disease. Biol Blood Marrow Transplant 2002; 8: 444–452.
Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M et al. Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory. Cancer 2000; 89: 1634–1646.
Osoba D, Rodrigues G, Myles J, Zee B, Pater J . Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol 1998; 16: 139–144.
Mathiowetz V, Kashman N, Volland G, Weber K, Dowe M, Rogers S . Grip and pinch strength: normative data for adults. Arch Phys Med Rehabil 1985; 66: 69–74.
Brooks D, Parsons J, Tran D, Jeng B, Gorczyca B, Newton J et al. The two-minute walk test as a measure of functional capacity in cardiac surgery patients. Arch Phys Med Rehabil 2004; 85: 1525–1530.
Eiser N, Willsher D, Dore CJ . Reliability, repeatability and sensitivity to change of externally and self-paced walking tests in COPD patients. Respir Med 2003; 97: 407–414.
Daughton DM, Fix AJ, Kass I, Bell CW, Patil KD . Maximum oxygen consumption and the ADAPT quality-of-life scale. Arch Phys Med Rehabil 1982; 63: 620–622.
Ware Jr JE . SF-36 health survey update. Spine 2000; 25: 3130–3139.
Ware Jr JE, Sherbourne CD . The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care 1992; 30: 473–483.
McQuellon RP, Russell GB, Cella DF, Craven BL, Brady M, Bonomi A et al. Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale. Bone Marrow Transplant 1997; 19: 357–368.
Mitchell S, Reeve B, Cowen E, Fall-Dickson J, Gerber L, Guadagnini JP et al. Feasibility and reproducibility of the new NIH consensus criteria to evaluate response in chronic GVHD – a Pilot study. Blood 2005; 106 (Suppl 1): abstract #3121.
Vitali C, Bombardieri S, Jonsson R, Moutsopoulos HM, Alexander EL, Carsons SE et al. Classification criteria for Sjogren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis 2002; 61: 554–558.
Acknowledgements
The National Institutes of Health (NIH) Consensus Development Project on Criteria for Clinical Trials in Chronic GVHD was supported by the National Cancer Institute, Office of the Director, Cancer Therapy Evaluation Program, Intramural Research Program, and Center for Cancer Research; National Heart Lung and Blood Institute, Division of Blood Diseases and Resources; Office of Rare Diseases, NIH, Office of the Director; National Institute of Allergy and Infectious Disease, Transplantation Immunology Branch; and the Health Resources and Services Administration, Division of Transplantation and the Naval Medical Research Center, CW Bill Young/Department of Defense Marrow Donor Recruitment and Research Program. The authors would also like to acknowledge the following organizations that by their participation made this project possible: American Society for Blood and Marrow Transplantation, European Group for Blood and Marrow Transplantation, Center for International Bone and Marrow Transplant Research, Blood and Marrow Transplant Clinical Trials Network, Canadian Blood and Marrow Transplant Group and Pediatric Blood and Marrow Transplant Consortium. The organizers are also indebted to patients and patient and research advocacy groups who made this process much more meaningful by their engagement. The project group recognizes contributions of numerous colleagues in the field of blood and marrow transplantation, medical specialists and consultants, pharmaceutical industry, and the National Institutes of Health and US Food and Drug Administration professional staff for their intellectual input, dedication, and enthusiasm.
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Pavletic, S., Lee, S., Socie, G. et al. Chronic graft-versus-host disease: implications of the National Institutes of Health consensus development project on criteria for clinical trials. Bone Marrow Transplant 38, 645–651 (2006). https://doi.org/10.1038/sj.bmt.1705490
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DOI: https://doi.org/10.1038/sj.bmt.1705490
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