title: Evaluation of NIH consensus criteria for classification of late acute and chronic GVHD.
abstract: Historically, graft-versus-host disease (GVHD) beyond 100 days after hematopoietic cell transplantation (HCT) was called chronic GVHD, even if the clinical manifestations were indistinguishable from acute GVHD. In 2005, the National Institutes of Health (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 HCT between 1994 and 2000. The presence or absence of NIH criteria for chronic GVHD showed no statistically significant association with survival, risks of nonrelapse mortality or recurrent malignancy, or duration of systemic treatment. Antecedent late acute GVHD was associated with an increased risk of nonrelapse 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.
authors.affiliation: Bone Marrow Transplant Program at the State University of Campinas, Sao Paulo, Brazil.
authors.forename: Afonso C
authors.initials: AC
authors.lastname: Vigorito
authors.forename: Paulo V
authors.initials: PV
authors.lastname: Campregher
authors.forename: Barry E
authors.initials: BE
authors.lastname: Storer
authors.forename: Paul A
authors.initials: PA
authors.lastname: Carpenter
authors.forename: Carina K
authors.initials: CK
authors.lastname: Moravec
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Kiem
authors.forename: Matthew L
authors.initials: ML
authors.lastname: Fero
authors.forename: Edus H
authors.initials: EH
authors.lastname: Warren
authors.forename: Stephanie J
authors.initials: SJ
authors.lastname: Lee
authors.forename: Frederick R
authors.initials: FR
authors.lastname: Appelbaum
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Martin
authors.forename: Mary E D
authors.initials: ME
authors.lastname: Flowers
mesh_terms: D000208:Acute Disease; D002908:Chronic Disease; D015975:Consensus Development Conferences, NIH as Topic; D006086:Graft vs Host Disease / Q000145:classification* / Q000175:diagnosis / Q000401:mortality; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects / Q000379:methods; D006801:Humans; D009316:National Institutes of Health (U.S.); D017410:Practice Guidelines as Topic; D012008:Recurrence; D012189:Retrospective Studies; D016019:Survival Analysis; D013997:Time Factors; D014481:United States