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Decitabine (DEC) therapy improved response rate and led to a longer Progression Free Survival (PFS) in older Acute Myeloid Leukemia (AML) patients with Monosomal Karyotype (MK) according to results of a sub-analysis of the phase III randomized DACO-016 study (NCT00260832), published in American Journal of Hematology by Agnieszka Wierzbowska [member of the AML Global Portal (AGP) European Steering Committee] from the Medical University of Lodz, Lodz, PL, and colleagues.1
The phase III randomized DACO-016 study compared DEC versus Treatment Choice (TC) in older patients with newly diagnosed AML. Findings of this study demonstrated that DEC led to an improved complete response rate and a longer Overall Survival (OS) compared to TC in older newly diagnosed AML.2 Wierzbowska et al., conducted a post-hoc analysis whose main objectives were to determine the effects of DEC versus TC on outcomes of AML patients with MK+ disease, and to compare versus MK− AML with other unfavorable karyotypes.1
In this DACO-016 study, 485 newly diagnosed AML patients were randomly assigned to either receive decitabine (20 mg/m2 /day for 5 consecutive days every 4 weeks) or TC (best supportive care or cytarabine 20 mg/m2/day for 10 days every 4 weeks). Of these, patients with MK+ (n = 64 [DEC, n = 33, TC, n = 31]) and MK- with poor cytogenetics (n = 99 [DEC, n = 49, TC, n = 50) were identified and included in this post-hoc analysis.
The authors concluded by highlighting that DEC “improved response rates and PFS compared with other standard therapies for patients who were ineligible for intensive chemotherapy, with a benefit of almost 4 months in median OS”. Furthermore, "decitabine may overcome the extremely poor prognosis associated with MK, and may be a beneficial initial treatment in these patients".
Key limitations of this post-hoc study include the open-label design of the DACO-016 study, the post-hoc nature of the analysis, and the relatively small number of patients. The authors noted that the findings of this post-hoc analysis should be confirmed in large prospective studies.
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