RSS-Feed abonnieren

DOI: 10.1055/s-0045-1811939
Role of Maintenance Therapy with Decitabine in Acute Myeloid Leukemia in First Remission: A Prospective Interventional Study from a Tertiary Care Center in Eastern India
Authors

Abstract
Introduction
Major advances in the diagnostic methodologies and technological progress have led to successful development of many targeted agents in the management of acute myeloid leukemia (AML). At present, standard of care of AML postremission depends on the molecular risk stratification of the disease. Despite incorporation of newer agents with chemotherapy, relapse remains a major problem. To address this unmet need, many investigators have used hypomethylating and other targeted drugs as maintenance after remission induction in AML in different clinical studies with variable results.
Objectives
We conducted this study to determine the efficacy of maintenance decitabine in AML after remission and to assess its side effects.
Materials and Methods
This is a prospective interventional study. After considering the inclusion and exclusion criteria, patients with a diagnosis of AML were given 3 + 7 induction. All adverse risk patients were counseled for allogeneic hematopoietic stem cell transplantation and removed from the study if they opted for that. After documenting remission, patients were given three high-dose cytarabine (HIDAC) as consolidation. Those who remain on remission after third HIDAC were started on decitabine maintenance at 12 weeks' interval. A total of 20 patients were included. They were followed up at 3 monthly intervals by complete blood count, peripheral blood smear, and bone marrow aspiration during maintenance. Disease-free survival (DFS) and overall survival (OS) were calculated and compared with historical control. Toxicity and side effects of decitabine were also assessed.
Results
At a median follow-up of 29 months, the median DFS and OS were 20.5 and 27.5 months, respectively. Seven patients experienced grade 3 and 1 patient grade 4 hematological adverse events. One patient died due to febrile neutropenia.
Conclusion
Decitabine may be considered as safe and effective maintenance agent in AML after achieving first remission.
Patient Consent
Patient consent has been obtained.
Place of study -Hematology department, Nil Ratan Sirkar Medical College & Hospital (NRSMCH).
Publikationsverlauf
Artikel online veröffentlicht:
25. September 2025
© 2025. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)
Thieme Medical and Scientific Publishers Pvt. Ltd.
A-12, 2nd Floor, Sector 2, Noida-201301 UP, India
-
References
- 1 Rashidi A, Weisdorf DJ, Bejanyan N. Treatment of relapsed/refractory acute myeloid leukaemia in adults. Br J Haematol 2018; 181 (01) 27-37
- 2 Löwenberg B, Suciu S, Archimbaud E. et al; European Organization for the Research and Treatment of Cancer and the Dutch-Belgian Hemato-Oncology Cooperative Hovon Group. Mitoxantrone versus daunorubicin in induction-consolidation chemotherapy–the value of low-dose cytarabine for maintenance of remission, and an assessment of prognostic factors in acute myeloid leukemia in the elderly: final report. J Clin Oncol 1998; 16 (03) 872-881
- 3 Perel Y, Auvrignon A, Leblanc T. et al; Group LAME of the French Society of Pediatric Hematology and Immunology. Impact of addition of maintenance therapy to intensive induction and consolidation chemotherapy for childhood acute myeloblastic leukemia: results of a prospective randomized trial, LAME 89/91. Leucámie Aiqüe Myéloïde Enfant. J Clin Oncol 2002; 20 (12) 2774-2782
- 4 Senapati J, Kadia TM, Ravandi F. Maintenance therapy in acute myeloid leukemia: advances and controversies. Haematologica 2023; 108 (09) 2289-2304
- 5 Terwilliger T, Abdul-Hay M. Acute lymphoblastic leukemia: a comprehensive review and 2017 update. Blood Cancer J 2017; 7 (06) e577
- 6 Acute myeloid leukemia: Developing drugs and biological products for treatment Guidance for industry | FDA. Accessed August 31, 2025 at: https://www.fda.gov/media/140821
- 7 Boumber Y, Kantarjian H, Jorgensen J. et al. A randomized study of decitabine versus conventional care for maintenance therapy in patients with acute myeloid leukemia in complete remission. Leukemia 2012; 26 (11) 2428-2431
- 8 Bahl A, Sharma A, Raina V. et al. Long-term outcomes for patients with acute myeloid leukemia: a single-center experience from AIIMS, India. Asia Pac J Clin Oncol 2015; 11 (03) 242-252
- 9 Shlush LI, Zandi S, Mitchell A. et al; HALT Pan-Leukemia Gene Panel Consortium. Identification of pre-leukaemic haematopoietic stem cells in acute leukaemia. Nature 2014; 506 (7488): 328-333
- 10 Foran JM, Sun Z, Claxton DF. et al. Maintenance decitabine (DAC) improves disease-free (DFS) and overall survival (OS) after intensive therapy for acute myeloid leukemia (AML) in older adults, particularly in FLT3-ITD-negative patients: ECOG-ACRIN (E-A) E2906 randomized study. Blood 2019; 134 (Suppl. 01) 115
- 11 Blum W, Sanford BL, Klisovic R. et al; Alliance for Clinical Trials in Oncology. Maintenance therapy with decitabine in younger adults with acute myeloid leukemia in first remission: a phase 2 Cancer and Leukemia Group B Study (CALGB 10503). Leukemia 2017; 31 (01) 34-39
- 12 Senapati J, Shoukier M, Garcia-Manero G. et al. Activity of decitabine as maintenance therapy in core binding factor acute myeloid leukemia. Am J Hematol 2022; 97 (05) 574-582
- 13 Huls G, Chitu DA, Havelange V. et al; Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON). Azacitidine maintenance after intensive chemotherapy improves DFS in older AML patients. Blood 2019; 133 (13) 1457-1464
- 14 Wei AH, Döhner H, Pocock C. et al; QUAZAR AML-001 Trial Investigators. Oral azacitidine maintenance therapy for acute myeloid leukemia in first remission. N Engl J Med 2020; 383 (26) 2526-2537
- 15 Bazinet A, Kantarjian H, Borthakur G. et al. A phase II study of azacitidine plus venetoclax as maintenance therapy in acute myeloid leukemia: durable responses with longer term follow-up. Blood 2022; 140 (Suppl. 01) 9005-9007
- 16 Hunault M, Maillard N, Tanguy-Schmidt A. et al. Safety and longterm efficacy of maintenance therapy with alternating azacytidine (AZA) and lenalidomide (Len) cycles in elderly (≥ 60) fit patients (Pts) with poor prognosis AML in first complete remission (CR) after LIA induction. A phase II multicentric GOELAMS trial. Blood 2015; 126 (23) 3787
- 17 Borthakur G, Ravandi F, Patel K. et al. Retrospective comparison of survival and responses to Fludarabine, Cytarabine, GCSF (FLAG) in combination with gemtuzumab ozogamicin (GO) or Idarubicin (IDA) in patients with newly diagnosed core binding factor (CBF) acute myelogenous leukemia: MD Anderson experience in 174 patients. Am J Hematol 2022; 97 (11) 1427-1434