|Title||Acute GVHD Diagnosis and Adjudication in a Multicenter Trial: A Report From the BMT CTN 1202 Biorepository Study.|
|Publication Type||Journal Article|
|Year of Publication||2021|
|Authors||Reshef, R, Saber, W, Bolaños-Meade, J, Chen, G, Bin Chen, Y-, Ho, VT, Ponce, DM, Nakamura, R, Martens, MJ, Hansen, JA, Levine, JE|
|Journal||J Clin Oncol|
|Date Published||2021 06 10|
|Keywords||Adolescent, Adult, Aged, Child, Child, Preschool, Clinical Trials as Topic, Databases, Factual, Female, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Incidence, Infant, Male, Middle Aged, Young Adult|
PURPOSE: Accurate and reproducible methods to diagnose, grade, and report acute graft-versus-host disease (GVHD) are critical for the evaluation of therapies and biomarkers.
PATIENTS AND METHODS: The Blood and Marrow Transplant Clinical Trials Network 1202 study is an observational study of 1,709 allogeneic hematopoietic cell transplantation recipients that implemented weekly data reporting and near real-time data adjudication by an end point review committee (ERC), assigning a confidence level (confirmed, probable, possible, or negative) to the diagnosis of acute GVHD at onset.
RESULTS: During the first 100 days, symptoms consistent with GVHD developed in 90% of cases but were often determined by centers to be due to causes other than GVHD. Indeed, GVHD was under consideration in only 23% of cases at symptom onset. Diagnostic biopsies were obtained in 40% of cases, but treatment often was incongruous with biopsy findings and 10.5% of biopsies were equivocal. Importantly, more than 40% of steroid courses were started for reasons other than GVHD. The ERC modified the determination of GVHD diagnosis and/or grade in 12.3% of onset cases. The cumulative incidence of acute GVHD as reported by the centers was 62%. When the ERC adjudicated GVHD onset to be present only if the confidence level was probable or confirmed, the incidence of GVHD declined to 49%.
CONCLUSION: This study demonstrates that the incidence of GVHD may be overestimated at symptom onset, establishes a contemporary benchmark for acute GVHD, and suggests a structured framework for reporting and adjudication of GVHD that could be used in prospective trials.
|Alternate Journal||J Clin Oncol|
|PubMed Central ID||PMC8260916|
|Grant List||U10 HL069294 / HL / NHLBI NIH HHS / United States |
UG1 HL069249 / HL / NHLBI NIH HHS / United States
UG1 HL138645 / HL / NHLBI NIH HHS / United States
U24 CA076518 / CA / NCI NIH HHS / United States
U24 HL138660 / HL / NHLBI NIH HHS / United States