A multicenter feasibility study of chronic graft-versus-host disease according to the National Institute of Health criteria: efforts to establish a Brazil-Seattle consortium as a platform for future collaboration in clinical trials.
BACKGROUND: New criteria for the diagnosis and classification of chronic graft-versus-host disease were developed in 2005 for the purpose of clinical trials with a consensus sponsored by the National Institute of Health.  OBJECTIVES: The aim of this study is to present the results of a multicenter pilot study performed by the Brazil-Seattle chronic graft-versus-host disease consortium to determine the feasibility of using these criteria in five Brazilian centers.  METHODS: The study was performed after translation of the consensus criteria into Portuguese and training. A total of 34 patients with National Institute of Health chronic graft-versus-host disease were enrolled in the pilot study between June 2006 and May 2009.  RESULTS: Of the 34 patients, 26 (76%) met the criteria of overlap syndrome and eight (24%) the classic subcategory. The overall severity of disease was moderate in 21 (62%) and severe in 13 (38%) patients. The median time from transplant to onset of chronic graft-versus-host disease was 5.9 months (Range: 3 - 16 months); the median time for the overlap syndrome subcategory was 5.9 months (Range: 3 - 10 months) and for the classic subcategory, it was 7.3 months (Range: 3 - 16 months). At a median follow up of 16.5 months (Range: 4 - 39 months), overall survival was 75%.  CONCLUSIONS: It was feasible to use the National Institute of Health consensus criteria for the diagnosis and scoring of chronic graft-versus-host disease in a Brazilian prospective multicenter study. More importantly, a collaborative hematopoietic cell transplantation network was established in Brazil offering new opportunities for future clinical trials in chronic graft-versus-host disease and in other areas of research involving hematopoietic stem cell transplantation.
Universidade Estadual de Campinas - UNICAMP, Campinas, SP, Brazil.
Afonso Celso
AC
Vigorito
Luis Fernando da Silva
LF
Bouzas
Maria Cláudia Rodrigues
MC
Moreira
Vaneuza Araújo Moreira
VA
Funke
Virgílio Antonio Rensi
VA
Colturato
Andréia
A
Pedro
Clarissa Vasconcellos de
CV
Souza
Elenaide Coutinho
EC
Nunes
Eliana Cristina Martins
EC
Miranda
Kátia
K
Camacho
Marcos Augusto
MA
Mauad
Maria Elvira Pizzigatti
ME
Correa
Márcia de Matos
MD
Silva
Mair Pedro de
MP
Sousa
Rita de Cássia Barbosa da Silva
RD
Tavares
Stephanie Joi
SJ
Lee
Mary Evelyn Dantas
ME
Flowers