Six-month freedom from treatment failure is an important end point for acute GVHD clinical trials.

Sengsayadeth S, Savani BN, Jagasia M, Goodman S, Greer JP, Chen H, Chinratanalab W, Kassim AA, Engelhardt BG
Bone Marrow Transplant. 2014 49 (2): 236-40

PMID: 24096824 · PMCID: PMC3946331 · DOI:10.1038/bmt.2013.157

We studied the American Society for Blood and Marrow Transplantation (ASBMT) 6-month (m) freedom from treatment failure (FFTF) as a predictor of survival for patients with acute GVHD (aGVHD) requiring treatment. Adult patients undergoing allogeneic hematopoietic cell transplant (HCT) from February 2007 to March 2009 who were enrolled in a prospective biomarker clinical trial and developed aGVHD requiring systemic corticosteroids by day +100 were included (N=44). Six-month FFTF was defined as per the ASBMT guidelines (absence of death, malignancy relapse/progression or systemic immunosuppression change within 6 months of starting steroids and before chronic GVHD development). aGVHD was treated with systemic corticosteroids in 44 patients. Day 28 response after steroid initiation (complete response+very good partial response+partial response) occurred in 38 (87%) patients, but only 28 (64%) HCT recipients met the 6-m FFTF end point. Day 28 response predicted 6-m FFTF. Achieving 6-m FFTF was associated with improved 2-year (y) OS (81% vs 48%; P=0.03) and decreased 2-y non-relapse mortality (8% vs 49%; P=0.01). In multivariate analysis, 6-m FFTF continued to predict improved OS (hazard ratio, 0.27; P=0.03). The 6-m FFTF end point measures fixed outcomes, predicts long-term therapeutic success and could be less prone to measurement error than aGVHD clinical response at day 28.

MeSH Terms (14)

Acute Disease Adult Aged Female Graft vs Host Disease Hematopoietic Stem Cell Transplantation Humans Male Middle Aged Survival Analysis Transplantation, Homologous Transplantation Conditioning Treatment Failure Treatment Outcome

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