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Association between Treatment Response and Potential Indicators of Efficacy and Safety in a Phase III Trial of Decitabine in Older Patients with Acute Myeloid Leukemia

Mark D. Minden, Christopher Arthur, Jiří Mayer, Mark M. Jones, Erhan Berrak and Hagop Kantarjian

Objective: In a phase III trial, 485 patients aged 65 years or older with newly diagnosed acute myeloid leukemia received decitabine (20 mg/m2 intravenously for 5 days) or treatment of choice (supportive care or cytarabine 20 mg/m2 subcutaneously for 10 days) every 4 weeks. This post hoc analysis investigated potential efficacy and safety indicators and treatment response.

Methods: Transfusions, intravenous antibiotics, and dose modifications were tabulated for responders (morphologic complete remission, complete remission with incomplete blood count recovery, or partial response) and nonresponders.

Results: Median overall survival was significantly greater for treatment responders than for nonresponders (17.4 months vs 4.3 months; P<0.0001). Nonresponders had more intravenous antibiotic use (P=0.024), dose modifications per cycle (P=0.016), and platelet or red blood cell transfusions per cycle (P<0.0001).

Conclusions: Response to decitabine or to treatment of choice may be associated with certain indicators in older patients with acute myeloid leukemia.