A Post Hoc Sensitivity Analysis of Survival Probabilities in a Multinational Phase III Trial of Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

In a randomized, open-label phase III study, decitabine elicited greater response rates and overall survival (OS) vs. cytarabine/supportive care in older patients with acute myeloid leukemia (AML). This post hoc analysis further delineates the survival trend observed with decitabine using a sensitivity analysis, with OS censored at fixed time points. A survival advantage was seen with decitabine at each time point. Background: In a multicenter, randomized, open-label phase III study, patients >= 65 years with newly diagnosed AML received decitabine 20 mg/m(2) once daily for 5 days every 4 weeks (n = 242) or treatment choice (supportive care or cytarabine 20 mg/m(2) once daily for 10 days every 4 weeks; n = 243). Decitabine use demonstrated greater response rates (P = .001) and OS data favored decitabine. Patients and Methods: In a post hoc sensitivity analysis of mature data of patients in the intent-to-treat population (N = 485), OS at 3, 6, 12, 18, and 24 months after randomization was estimated for each arm using Kaplan-Meier methods. Age, cytogenetic risk, and Eastern Cooperative Oncology Group performance status were used as stratification factors in the Cox regression model to estimate the hazard ratio. Results: A survival advantage was seen with decitabine at each cutoff time point; hazard ratios for OS for decitabine vs. treatment choice were 0.83, 0.71, 0.83, 0.80, and 0.79 at 3, 6, 12, 18, and 24 months, respectively. A trend toward improved OS with decitabine was observed at fixed time points over 2 years. Conclusion: Decitabine should be considered as a treatment option for older patients with AML and poor prognostic risk factors. (C) 2014 Elsevier Inc. All rights reserved.