DECITABINE FOR MYELODYSPLASTIC SYNDROME AND ELDERLY ACUTE MYELOID LEUKEMIA -A TERTIARY CENTRE DATA FROM INDIA
Keywords:MDS, AML, Decitabine, IWG, Neutropenia
Objective: To assess the clinical profile of patients receiving Decitabine for myelodysplastic syndromes (MDS) and Acute myeloid leukemia (AML).
Methods: 14 patients had been initiated on Decitabine which included 11 MDS patients and 3 AML patients. Response was defined for MDS according to the International Working Group (IWG) 2006 criteria, whereas for AML according to IWG-AML 2003 criteria. Toxicities were graded according to the National Cancer Institute/Common Toxicity Criteria guidelines, version four.
Results: Out of the 14 patients overall response was achieved in 7 patients (50%) including 4 complete remission (29%), 1 partial remission (7%) and 2 stable diseases with hematological improvement (HI-N 1, HI-P 1 (14%). In case of MDS over all response was found in 6 patients (55%) including 3 patients with CR (27.5%), 1 PR (9%) and 2 stable diseases with HI (27%). Out of 14 patients 5 patients showed treatment failure (36%). One MDS patient showed disease progression and other one discontinued Decitabine. The most commonly occurred adverse effect noted was neutropenia which was observed in 13 patients (92.85%) and least commonly occurred were fatigue (13%) and fever (13%).
Conclusion Almost similar efficacy and safety profile were observed after comparing our data with ADOPT trial conducted by David P Steensma et al. The patients with MDS and AML had a lower median age at presentation compared with western data. We also noticed a worsening of pre-existing renal dysfunction observed in one patient after the second cycle of Decitabine which reversed upon stopping the drug.
Jacqueline SG, Nitin J, Lucy AG. An update on the safety and efficacy of decitabine in the treatment of myelodysplastic syndromes. Onco Targets Ther 2010;3:1-13.
Appelbaum FR. Acute myeloid leukemia in adults. Clin Onco 2008;1:2215-34.
Edwardchu, Vincent T. The physicians`s cancer chemotherapy drug manual; 2010. p. 121-3.
Steensma DP, Baer MR, Slack JL. Multicenter study of decitabine administered daily for 5 days every 4 weeks to adults with myelodysplastic syndromes: the alternative dosing for outpatient treatment (ADOPT) trial. J Clin Oncol 2009;27(23):3842-8.
Joseph M, Scandura, Gail JR, Michelle M. Phase 1 study of epigenetic priming with decitabine prior to standard induction chemotherapy for patients with AML. Blood 2011;118(6):1472-80.
James W, Vardiman, Juergen T, Daniel A. The 2008 revision of the World Health Organization (WHO) classification of myeloid neoplasms and acute leukemia rationale and important. Blood 2009;114:937-51.
Cheson BD, Greenberg PL, Bennett JM. Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia. Blood 2006;108:419â€“25.
Cheson BD, Bennett JM, Kopecky KJ. Revised recommendations of the international working group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia. J Clin Oncol 2003;21(24):4642-9.
Amanda F, Gary JS, Margaret R. Multicenter phase ii study of decitabine for the first-line treatment of older patients with acute myeloid leukemia. J Clin Oncol 2010;28(4):556-61.