Original Article DECITABINE FOR MYELODYSPLASTIC SYNDROME AND ELDERLY ACUTE MYELOID LEUKEMIA- A TERTIARY CENTRE DATA FROM INDIA JINCY ELDHOSE*, GLINDOW ANTONY, JITHU JOSEPH, NAVEEN KUMAR PANICKER, NEERAJ SIDHARTHAN 1 Amrita School of Pharmacy, Amrita Institute of Medical Sciences and Research Centre, Kochi 41, 2 Department of Medical Oncology and Haematology Amrita Institute of Medical Sciences and Research Centre Ponekkara, AIMS. P. O, Kochi 41. Email: annamaryeldhose@yahoo.in Received: 03 Aug 2014 Revised and Accepted: 05 Sep 2014 ABSTRACT 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. Keywords: MDS, AML, Decitabine, IWG, Neutropenia. INTRODUCTION Myelodysplastic syndromes (MDS) is a heterogeneous group of clonal stem cell disorders, with hypercellular bone marrow, peripheral cytopenias, and dysplasia in both peripheral blood and bone marrow.[1] Acute Myeloid Leukemia (AML) is a form of cancer that affects the cells producing myeloid blood cells in the bone marrow. Myeloid cells are red blood cells, platelets and all white cells except lymphocytes. Almost all cases of AML affect those cells in the bone marrow which produces white blood cells. More rarely AML may affect other cells in the bone marrow which produce red blood cells or platelets. [2] Decitabine is an "antimetabolite" and a "demethylating" agent was approved by the US Food and Drug Administration (FDA) in 2006 for the treatment of Myelodysplastic Syndromes (MDS) and Elderly Acute myeloid leukemia (AML). It is a Deoxycytidine analog, cell cycle specific with activity in the S-phase.[3] Western studies [4],[5] have already proven the safety and efficacy of Decitabine in the treatment of MDS and AML patients. To the best of our knowledge, this is the first Indian data focusing on safety and efficacy of Decitabine. MATERIALS AND METHODS Non-experimental (observational), both Retrospective and prospective follow up study was carried out on patients at the Medical Oncology and Haematology Department of Amrita Institute of Medical Sciences(AIMS) Kochi, from December 2012 to June 2013. The study was carried out after getting approval from the Research and Ethics Committee. Patient’s data of all the MDS and AML patients of medical oncology department, taking decitabine are collected and those satisfying the inclusion and exclusion criteria were selected for the study. Classification MDS was categorized according to the World Health Organization (WHO) and IPSS classification and AML as per the criteria of FAB/WHO.[6] Treatment Approved dose of Decitabine is 20 mg/m 2 administered as a 1-hour IV infusion once daily on 5 consecutive days and cycle repeated every 4 weeks. Cycle was repeated until a suitable response was achieved. Decitabine is stable in room temperature up to 8 hours when diluted in 100 ml normal saline. Individual dose was calculated based on the patients BSA. All patients received the same Decitabine total dose per course, 100 mg/m 2 Assessment of efficacy in 1 cycle. Response was evaluated after Decitabine treatment by blood count, bone marrow aspirate, and cytogenetic studies. Response was defined for MDS as an achievement of complete response (CR), partial response (PR), marrow CR(mCR) or hematologic improvement (HI) according to the International Working Group (IWG) 2006 criteria [7],for AML as achievement of CR, PR, or CRi (ie, CR with incomplete recovery of cytopenias) according to IWG-AML 2003 criteria.[8] Assessment of safety Toxicities were graded according to the Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Grade refers to the severity of the adverse event. The CTCAE displays grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening consequences and Grade 5 Death related to AE. RESULT Pretreatment characteristics of the patient population The study population consisted 9 men and 5 women, with median age for patients suffering from MDS and AML was found to be 57 and 63 respectively. As per the criteria of the International prognostic scoring system (IPSS) 9 patients come within intermediate risk 1 and 2 patients within intermediate risk 2 (Table 1). From this classification, it was found that more number of patients are International Journal of Pharmacy and Pharmaceutical Sciences ISSN- 0975-1491 Vol 6, Issue 10, 2014 Innovare Academic Sciences