Successful treatment of patients with acute myeloid leukemia and Myelodysplastic Syndrome by decitabine

Objectives: The goal of this study was to identify the safety and efficacy of decitabine. Design: Retrospective study Setting: Department of Hematology, Ege University Faculty of Medicine Subjects: Data of patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) who were treated with decitabine were evaluated retrospectively. Intervention(s): Decitabine was administered 20 mg/m(2) by intravenous infusion daily for five consecutive days every four weeks. The primary end point was overall response rate (ORR). Survival, overall improvement rate (OIR), hematologic improvement (HI) and drug toxicity were analyzed. Main outcome measure(s): Overall survival (OS), progression-free survival (PFS), ORR and hematologic adverse event for both AML and MDS, OIR including HI for MDS. Results: Twenty-five MDS and thirteen AML patients were enrolled. In MDS group, median OS and PFS were 21 months and 14 months, respectively. The ORR was 48% and OIR was 60%, which included 12% HI. Seventy-two of the patients experienced stable disease or better. For AML, ORR was 46.2%, and median OS and PFS data were not reached as 76% (n=10) of patients are still alive, and 38% (n=5) of patients are still receiving treatment. At one year, OS and PFS were 61.4% and 77.8%, respectively. Conclusion: Decitabine is effective and safe with acceptable toxicity in intermediate and high-risk MDS patients and elderly patients with AML.