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The real-life efficacy of fixed-dose hypomethylating agents in older patients with acute myeloid leukemia: A 10-year experience

Published: 14 July 2021

Abstract: Background Hypomethylating agents (HMAs) is one of recommended treatment for elderly patients with acute myeloid leukemia (AML); however, their high cost precludes their general use, especially in developing countries. Therefore, the fixed-dose HMAs approach was adopted to reduce the expenses. This study focuses on the clinical outcome of various treatment protocols, including intensive chemotherapy, fixed-dose HMAs, and palliative treatment in Thai elderly patients with AML. Fixed-dose HMAs include 5-azacitidine given at 100 mg per day for seven days and decitabine given at 30 mg per day for five days. Patients and Methods: We conducted a 10-year cohort study focused on elderly AML patients aged over 60 years. The exclusion criteria were acute promyelocytic leukemia. Results A total of 243 AML patients were enrolled. Comparing three groups of treatment regimens (intensive chemotherapy, fixed-dose HMAs, and palliative treatment), the proportions of patients in each category accounted for 23.5%, 21.4%, and 55.1%, respectively. The median overall survival (OS) in each therapeutic option was 7.7, 11, and 2.5 months, respectively. From multivariate analysis, palliative treatment was significantly inferior OS comparing to the fixed-dose HMAs and intensive treatment (HR: 0.42; 95%CI: 0.29-0.60; P-value < 0.001 and HR: 0.41; 95%CI: 0.28-0.61; P-value < 0.001, respectively). Nevertheless, the OS outcome in patients with fixed-dose HMAs was comparable to those who received intensive treatment. Conclusion Our study demonstrates that the fixed-dose regimen of HMAs is the reasonable treatment for these patients, and this approach is not inferior to intensive therapy. Thai Clinical Trials Registry identifier: TCTR20210514007. Micro-Abstract Hypomethylating agents (HMAs) is an effective treatment for elderly AML patients. To reduce expenses, the fixed-dose HMAs are commonly used in our institute, instead of a weight-adjusted dose. Patients receiving fixed-dose HMAs had significantly superior OS comparing to those receiving palliative treatment. Moreover, the survival outcome of the fixed-dose HMAs arm was comparable to intensive chemotherapy arm.
Keywords: AML / Azacitidine / Decitabine / elderly / HMAs / Thailand / List of abbreviations: AML / acute myeloid leukemia / ANC / absolute neutrophil count / CBC / complete blood count / CKD / chronic kidney disease / complete remission / DIC / disseminated intravascular coagulation / ECOG / Eastern Cooperative Oncology Group

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