Vigorito Afonso C, Campregher Paulo V, Storer Barry E, Carpenter Paul A, Moravec Carina K, Kiem Hans-Peter, Fero Matthew L, Warren Edus H, Lee Stephanie J, Appelbaum Frederick R, Martin Paul J, Flowers Mary E D
Bone Marrow Transplant Program at the State University of Campinas, Sao Paulo, Brazil.
Blood. 2009 Jul 16;114(3):702-8. doi: 10.1182/blood-2009-03-208983. Epub 2009 May 21.
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.
从历史上看，造血细胞移植（HCT）100天后出现的移植物抗宿主病（GVHD）被称为慢性GVHD，即便其临床表现与急性GVHD难以区分。2005年，美国国立卫生研究院（NIH）主办了一次共识会议，会上提出了用于临床试验的慢性GVHD诊断和分类新标准。根据共识标准，在临床试验中应依据临床表现而非移植后的时间来区分慢性GVHD与晚期急性GVHD，晚期急性GVHD包括持续性、复发性或迟发性急性GVHD。在一项针对1994年至2000年间接受异基因HCT后被诊断为历史定义的慢性GVHD的740例患者的回顾性研究中，我们根据是否存在NIH慢性GVHD标准评估了主要结局。是否存在NIH慢性GVHD标准与生存率、非复发死亡率或复发恶性肿瘤风险以及全身治疗持续时间均无统计学显著关联。在符合NIH慢性GVHD标准的患者中，先前的晚期急性GVHD与非复发死亡率增加及治疗时间延长相关。我们的结果支持了共识建议，即在进行适当分层后，临床试验可纳入晚期急性GVHD患者以及符合NIH慢性GVHD标准的患者。
