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Blood, 16 July 2009, Vol. 114, No. 3, pp. 702-708.
Prepublished online as a Blood First Edition Paper on May 21, 2009; DOI 10.1182/blood-2009-03-208983.
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Submitted March 9, 2009
Accepted May 16, 2009
Evaluation of NIH consensus criteria for classification of late acute and chronic GVHD
Afonso C. Vigorito, Paulo V. Campregher, Barry E. Storer, Paul A. Carpenter, Carina K. Moravec, Hans-Peter Kiem, Matthew L. Fero, Edus H. Warren, Stephanie J. Lee, Frederick R. Appelbaum, Paul J. Martin, and Mary E.D. Flowers*
Bone Marrow Transplant Program at the UNICAMP, Campinas, Sao Paulo, Brazil
Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA, United States
Department of Biostatistics, University of Washington School of Medicine, Seattle, WA, United States
Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, United States
Department of Medicine, University of Washington School of Medicine, Seattle, WA, United States
* Corresponding author; email: mflowers{at}fhcrc.org.
Historically, graft-versus-host disease (GVHD) beyond 100 days after hematopoietic cell transplant was called chronic GVHD, even if the clinical manifestations were indistinguishable from acute GVHD. In 2005, the NIH sponsored a consensus conference that proposed new criteria for diagnosis and classification of chronic GVHD for clinical trials. According to the consensus criteria, clinical manifestations rather than time after transplantation should be used in clinical trials to distinguish chronic GVHD from late acute GVHD, which includes persistent, recurrent or late-onset acute GVHD. We evaluated major outcomes according to the presence or absence of NIH criteria for chronic GVHD in a retrospective study of 740 patients diagnosed with historically defined chronic GVHD after allogeneic hematopoietic cell transplantation between 1994 and 2000. The presence or absence of NIH criteria for chronic GVHD showed no statistically significant association with survival, risks of non-relapse mortality or recurrent malignancy, or the duration of systemic treatment. Antecedent late acute GVHD was associated with an increased risk of non-relapse mortality and prolonged treatment among patients with NIH chronic GVHD. Our results support the consensus recommendation that, with appropriate stratification, clinical trials can include patients with late acute GVHD as well as those with NIH chronic GVHD.
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