Abstract

Objective:In this study, we aimed to investigate the efficacy and safety of azacitidine (AZA) in elderly patients with acute myeloid leukemia (AML), including patients with >30% bone marrow (BM) blasts.Materials and Methods:In this retrospective multicenter study, 130 patients of ≥60 years o ld who were ineligible for intensive chemotherapy or had progressed despite conventional treatment were included.Results:The median age was 73 years and 61.5% of patients had >30% BM blasts. Patients received AZA for a median of four cycles (range: 1-21). Initial overall response [including complete remission (CR)/CR with incomplete recovery/partial remission] was 36.2%. Hematologic improvement (HI) of any kind was documented in 37.7% of all patients. HI was also documented in 27.1% of patients who were unresponsive to treatment. Median overall survival (OS) was 18 months for responders and 12 months for nonresponders (p=0.005). In the unresponsive patient group, any HI improved OS compared to patients without any HI (median OS was 14 months versus 10 months, p=0.068). Eastern Cooperative Oncology Group performance status of <2, increasing number of AZA cycles (≥5 courses), and any HI predicted better OS. Age, AML type, and BM blast percentage had no impact.Conclusion:We conclude that AZA is effective and well tolerated in elderly comorbid AML patients, irrespective of BM blast count, and HI should be considered a sufficient response to continue treatment with AZA.

Highlights

  • Acute myeloid leukemia (AML) is predominantly a disease of older patients with a median age at diagnosis of ~70 years [1,2]

  • One hundred and twelve patients (86.2%) required erythrocyte and/ or thrombocyte transfusion, while 5.4% had an unfavorable karyotype and 50.8% had an intermediate karyotype according to Medical Research Council (MRC) criteria [16]

  • Incidence of AML increases with age and most patients are deemed unsuitable for intensive treatment options

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Summary

Introduction

Acute myeloid leukemia (AML) is predominantly a disease of older patients with a median age at diagnosis of ~70 years [1,2]. Patients not suitable for intensive chemotherapy or who did not respond to these treatment options are frequently offered best supportive care (BSC) only, and the prognosis is dismal [6,7]. The use of AZA was associated with improved survival when compared to BSC or low-dose cytarabine in patients with high-risk MDS, including those with marrow blast counts ranging from 20% to 30%, leading to AZA approval in these disease categories [8,10]. There are limited data showing the efficacy of AZA in AML patients with >30% bone marrow (BM) blasts

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