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Although azacitidine is the first‐line drug for higher‐risk myelodysplastic syndrome ( MDS ) patients, its efficacy for lower‐risk  MDS  remains unestablished. Therefore, we conducted a prospective study to examine the efficacy and safety of a 5‐day regimen of azacitidine ( AZA ‐5) for lower‐risk  MDS . The primary endpoint was hematological improvement ( HI ) after 4 courses of therapy. A total of 51 patients with lower‐risk  MDS  based on the French‐American‐British ( FAB ) classification (44 patients with refractory anemia [ RA ] and 7 patients with refractory anemia with ringed sideroblasts [ RARS ]) were enrolled from 6 centers in Japan. The median age was 75 years (range: 51‐88). These patients received  AZA ‐5 (75 mg/m 2 ; once daily for 5 sequential days). The median number of  AZA ‐5 courses was 8 (range: 1‐57), and 45 patients (88.2%) received more than 4 courses.  HI  and transfusion independency were seen in 24 patients (47.1%) and 11 patients (39.2%), respectively. A total of 11 patients (21.6%) achieved complete remission or marrow remission.  WT 1  mRNA  levels were not significantly correlated with therapy response. Grade 3 or 4 neutropenia and thrombocytopenia occurred in 26 (51.0%) and 11 (21.5%) patients, respectively. Nonhematological grade 3 or 4 adverse events were observed in 9 patients (17.6%). Together, these results indicate that  AZA ‐5 is feasible and effective for lower‐risk  MDS  patients as well as for higher‐risk  MDS  patients.

cancer science

Five‐day regimen of azacitidine for lower‐risk myelodysplastic syndromes (refractory anemia or refractory anemia with ringed sideroblasts): A prospective single‐arm phase 2 trial