Abstract
6578 Background: Myelodysplastic syndrome (MDS) is characterized by maturation defects in hematopoietic progenitor cells that result in ineffective hematopoiesis, various cytopenias and risk of progression to acute myeloid leukemia. MDS can arise de novo or secondary to exposure to myelotoxic drugs or ionizing radiation. Secondary MDS (t-MDS) tends to have more aggressive behavior than de novo MDS. Azacitidine (AZA), a DNA methyl transferase inhibitor has activity in MDS. To date there is little data in patients with t-MDS Methods: The records of 21 patients with t-MDS treated with AZA between 05/96 and 01/06 were reviewed to determine response, duration of response and tolerability in these high-risk patients. 15 of the 21 patients received AZA as part of a National Cancer Institute special exception program (75mg/m2 subcutaneously for seven days every four weeks). Patients who received at least 2 cycles were considered evaluable for response (N=16). All patients were evaluated for toxicity. The International working group standardized response criteria for MDS were used for evaluation. Results: Patients had a median age of 68 years; male: female ratio was 3:1. 11 patients had refractory anemia, 6 had refractory anemia with excess blasts, 3 had chronic myelomonocytic leukemia, 1 had refractory anemia with ringed sideroblasts. Response was seen in 8 (50%) of 16 patients, with 2 (12.5%) partial remissions, 6 (37.5%) showed major hematological response. The median duration of response was 12.3 months (range 4–38). Stable disease was seen in 5 patients (31%), with an average duration of 6.5 months (range 2–15). 3 patients failed therapy due to disease progression or death. Treatment was well tolerated in general, with the most side effects being nausea, vomiting, diarrhea and cytopenias. Febrile neutropenia was seen in 5 patients. Conclusions: Azacitidine appears to be effective and well tolerated in patients with t-MDS. [Table: see text]
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