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Abstract
This multicenter, open-label study evaluated the efficacy and safety of decitabine in patients from Argentina and South Korea with myelodysplastic syndromes or chronic myelomonocytic leukemia. Of 106 patients who received decitabine 20 mg/m2 intravenously over 1 h once daily for 5 days in 4-week cycles, 99 patients were evaluable after receiving at least two cycles. The overall improvement rate was 35% (19% complete response +4% marrow complete response +4% partial response +8% hematologic improvement). Overall survival at 2 years was 71%. Treatment-related adverse events included febrile neutropenia, thrombocytopenia and bleeding, asthenia, fatigue, and eosinophilia. After complete response (CR), three patients received an allogeneic stem cell transplant. Four patients who relapsed after CR responded to decitabine retreatment. Acute myelogenous leukemia developed during follow-up in 21% of patients. Decitabine in a 5-day outpatient administration schedule was effective and well tolerated in typical clinical practice settings in South America and Asia.
Acknowledgements
All authors had access to primary clinical trial data. The authors thank the following colleagues for their contributions to the study: R. Bengio, L. Quiroga, MD, J. Garcia, MD, J. Arbelbide, A. Pavlovsky, M. V. Prates, I. Fernandez, G. Garay, S. Saba, L. Salvatierra, MD, R. A. Giuliani, MD, G. Flores, A. Flores, MD, G. Alfonso, G. Milone, A. Basso, J. Pose, A. Corzo, D. Moro, M. Lluesma Goñalons, D. Saracut, M. Gonzalez, L. Palmer, A. Brodsky, G. Saidon, L. Melillo, C. Dufour, D. Fassi, C. Jozami, I. Santos, and C. Baduel. Jonathan Latham and Joanna Marshall provided assistance in the preparation of the manuscript on behalf of Janssen Cilag Farmaceutica S.A.
Declaration of interest: The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.