Decitabine (DACOGEN, Janssen Pharmaceutica N.V. and Eisai Inc.) is an efficient hypomethylating agent approved for the treatment of MDS in the United States and other countries. Previous studies from North America reported the efficacy and safety of decitabine 15 mg/m2 every 8 hours for 3 days every 6 weeks (3-d schedule;

Kantarjian, Cancer 2006;106:1794
) and 20 mg/m2 once daily for 5 days every 4 weeks (5-d schedule;
Kantarjian Blood 2007;109:52
and
Steensma, ASH 2007;110:1450
) in MDS patients. The aim of the study reported here was to assess the clinical efficacy and safety of the 3-d schedule of decitabine in MDS patients in Russia. A total of 15 patients with MDS were enrolled: 9 male and 6 female; average age 62 years. Diagnoses included refractory anemia with ringed sideroblasts (RARS) in 3 patients, refractory anemia with excess blasts (RAEB) in 9 patients, refractory anemia with excess blasts in transformation (RAEB-T) in 2 patients, and chronic myelomonocytic leukemia (CMML) in 1 patient. Cytogenetic abnormalities included: -Y in 2 patients, del(5q) in 2 patients, and del(5q)+t(11;17) in 1 patient. At the time of this analysis, decitabine treatment had been administered for 1–2 cycles in 7 patients and for 3 cycles in 8 patients. The most frequent grade ≥3 adverse events were neutropenia (n=8, including 5 with neutropenic fever) and thrombocytopenia (n=4). Two patients with RAEB-T had severe neutropenia with infection: a necrotic lesion of hemorrhoids (n=1) and lower limb cellulitis (n=1). No other grade ≥3 adverse events were observed. Among the 8 patients who had received 3 cycles of decitabine, transfusion dependence was 100% before treatment and 38% (3/8) after decitabine treatment, with prolongation of transfusion independence periods in all 8 patients. Average hemoglobin level was 6.8 g/dL before treatment and 8.4 g/dL after 3 cycles of decitabine treatment. Overall response rate was 50% after 3 cycles of decitabine, including complete response (CR) in 1 (13%) patient and partial response (PR) in 3 (38%) patients. The other 4 patients who had received 3 cycles of decitabine had stable disease. The median time to first treatment response was 2 cycles. In this study of MDS patients in Russia, toxicity was consistent with previous studies and patients responded well to decitabine treatment on a 3-day dosing schedule.

Topics:
decitabine, myelodysplastic syndrome, refractory anemia with excess blasts, adverse event, leukemia, myelomonocytic, chronic, neutropenia, refractory anemia with sideroblasts, transfusion, cancer, complete remission

Disclosures: No relevant conflicts of interest to declare.

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2008, The American Society of Hematology
2008
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