Purpose To compare low-dose decitabine to best supportive care (BSC) in higher-risk
patients with myelodysplastic syndrome (MDS) age 60 years or older and ineligible for
intensive chemotherapy. Patients and Methods Two-hundred thirty-three patients (median
age, 70 years; range, 60 to 90 years) were enrolled; 53% had poor-risk cytogenetics, and
the median MDS duration at random assignment was 3 months. Primary end point was
overall survival (OS). Decitabine (15 mg/m2) was given intravenously over 4 hours three …

Introduction: In 2002 the EORTC and the German MDS Study Group initiated a randomized
phase III study comparing low dose Decitabine to supportive care in patients (pts) of 60
years or older with primary or secondary MDS or CMML. MDS patients with either 11–20%
BM blasts or≤ 10% blasts and poor cytogenetics could be included. Pts with a BM blast
count between 21–30% without signs of disease progression for at least one month were
also candidates for the study. Methods: Patients were centrally randomized; stratification …