2 research outputs found
Low-dose Decitabine Vs best supportive care in older patients with AML and low blast counts: results of a subgroup analysis of the randomized phase III study 06011 of the EORTC leukemia cooperative group and german MDS study group
Decitabine versus best supportive care in older patients with refractory anemia with excess blasts in transformation (RAEBt) - results of a subgroup analysis of the randomized phase III study 06011 of the EORTC Leukemia Cooperative Group and German MDS Study Group (GMDSSG)
In the European Organisation for Research and Treatment of Cancer (EORTC)/GMDSSG phase III trial06011, we compared decitabine (15 mg/m² every 8 h for 3 days) with best supportive care (BSC) in patients >/= 60 years with myelodysplastic syndromes (MDS) by French-Amercian-British (FAB) criteria. Here, we reinvestigate trial 06011 for the activity and efficacy specifically in patients with refractory anemia with excess blasts in transformation (RAEBt). Response rates in the decitabine arm (N=40) were as follow: complete or partial remission, 15 %; hematologic improvement, 15 %; resistant disease, 30 %. RAEBt patients in the decitabine arm had longer progression-free survival (PFS; hazard ratio (HR) 0.30, 95 % confidence interval (CI) 0.18-0.51; median, 6.2 vs 2.8 months) and overall survival (OS; HR 0.68, 95 % CI 0.42-1.11; median, 8.0 vs 6.0 months) than in the BSC arm (N=35). Censoring at allogeneic hematopoietic stem cell transplantation, the OS difference between the treatment groups increased, particularly among patients