Abstract
Background: The European Medicines Agency Committee for Medical Products for Human Use and the Korean Food and Drug Administration approved decitabine as the first-line treatment for elderly patients with acute myeloid leukemia (AML) in 2012 and 2013, respectively. However, there are limited data supporting treatment choice of decitabine versus conventional chemotherapy for the treatment of elderly patients with newly diagnosed AML.
Methods & Materials: We retrospectively reviewed medical records of patients with age between 65 and 75 who were diagnosed with AML except acute promyelocytic leukemia between Nov, 2004 and June, 2015 at Severance hospital, Seoul, Korea. Patients who were treated with decitabine or conventional chemotherapy as the first-line therapy for remission induction were studied. Patients who had received hypomethylating agents before diagnosing AML were excluded. Progression free-survival was assessed from the date of documentation of complete response (CR) or CR with incomplete blood count recovery (CRi) to the date of disease progression or death in patients achieving CR or CRi.
Results: A total of 58 patients were studied. 16 and 42 patients were treated with decitabine and conventional chemotherapy (39 cytarabine with idarubicin; 3 fludarabine, cytarabine, and attenuated dose idarubicin), respectively, and compared in this study. The baseline characteristics of patient groups treated with decitabine or conventional chemotherapy were not significantly different in regard of gender (male; 62.5% vs. 50.0%; P = 0.557), performance status (median 1.0 vs. 1.0; P = 0.888), bone marrow blast percentage (median 55.5% vs. 69.1%; P = 0.162) and Charlson comorbidity score (median 0.0 vs. 0.0; P = 0.657). Age were older in decitabine-treated group than in group treated with conventional chemotherapy (median age 72 vs. 68; P < 0.001). Patients who were treated with conventional chemotherapy had poor cytogenetic risk more frequently than those who were treated with decitabine (45.0% vs. 13.3%; P = 0.040). CR or CRi were achieved in 42.9% of evaluable patients with decitabine therapy and 61.9% of evaluable patients with conventional chemotherapy (P = 0.232). The median overall survival (OS) (302 days in decitabine group; 95% CI: 269-335 vs. 286 days in conventional chemotherapy group; 95% CI: 130-441; P = 0.262) and progression free-survival (PFS) (284 days in decitabine group; 95% CI: 80-488 vs. 128 days in conventional chemotherapy group; 95% CI: 33-223; P = 0.572) were not significantly different between two groups. When performing subgroup analysis with patient groups having intermediate risk of cytogenetics (n = 10 in decitabine group, 20 in conventional chemotherapy group), there was no significant difference in regard of median OS (302 days in decitabine group; 95% CI: 276-328 vs. 486 days in conventional chemotherapy group; 95% CI: 190-782 days; P = 0.900) and PFS (284 days in decitabine group; 95% CI: 73-495 vs. 191 days in conventional chemotherapy group; 95% CI: 0-509; P = 0.698). Although there was no survival difference, overall hospitalization rates were lower in decitabine-treated patients when compared with conventional chemotherapy-treated patients (16.4% vs. 40.8%; P = 0.001).
Conclusions: First-linedecitabine therapy was not inferior to conventional chemotherapy in regard of response rate, OS, and PFS in elderly patients with AML despite older age in our study. In addition, decitabine therapy induced fewer hospitalizations than conventional chemotherapy.
No relevant conflicts of interest to declare.
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