A retrospective study comparing azacitidine with decitabine in Chinese patients with refractory anemia with excess blast based on two clinical trials in a single center.

: The aim of the present study was to conduct a retrospective analysis of efficacy and safety profiles of azacitidine (AZA) versus. decitabine (DAC) in Chinese patients with intermediate or higher-risk MDS, which was based on two clinical trials in a single center. A total of 40 included MDS patients diagnosed with refractory anemia with excess blast (RAEB) were from two independent clinic trials. Patients in each trial received either AZA (n = 19) or DAC (n = 21) respectively, and the effectiveness as well as the safety profile of the two drugs were compared. Patients treated with AZA showed a comparative efficacy to DAC group with regard to the overall response rate (73.7% versus. 76.2%, P = 0.86), overall survival (median: 19.3 versus. 20.8 months, P = 0.56), progression-free survival (median: 12.3 versus. 9.3 months, P = 0.43) and leukemia-free survival (median: 22.8 versus. 26.6 months, P = 0.62). Patients treated with DAC showed slightly higher incidence of severe hematological adverse events during the whole treatment. Comparing hematological AEs in each observation interval, a trend of higher percentage of neutropenia, leukopenia and anemia as well as treatment delays were seen during the first 6 cycles in the DAC group.