Objective: No head to head randomized clinical trial has previously been conducted to compare the clinical outcomes between the hypomethylating agents (HMAs), azacitidine and decitabine, in the treatment of older patients with Acute Myeloid Leukemia (AML). Our objective is to compare the survival outcomes between both HMAs by using the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database.
Methods: Patients 1) had their index diagnosis between January 1, 2007 and December 31, 2014, 2) were continuously enrolled in Medicare Part A, Part B and Part D, and 3) were not enrolled in Medicare Advantage at the time of index AML diagnosis. Kaplan-Meier curves and Cox proportional hazards regression assessed overall survival by treatment.
Results: Of the 3,922 patients who received front-line AML treatment, 28% and 29% received decitabine and azacitidine, respectively. The median age (mean) of azacitidine and decitabine was 75 (75) and 74 (74) years, respectively. The racial distribution was also similar with 88% and 86% of whites in the azacitidine and decitabine groups, respectively. 41% of azacitidine and 40% of decitabine treated patients were male. The median overall survival (mOS) of patients who received azacitidine and decitabine was 213 (95% confidence interval (CI): 195-236) and 217 (CI: 194-234) days, respectively. In patients <75 years, the mOS of azacitidine and decitabine treated patients was 246 (CI: 220-283) and 252 (CI: 227-289) days, respectively. In patients ≥75 years, the mOS of azacitidine and decitabine treated patients was 185 (CI: 158-210) and 179 (CI: 152-201) days, respectively. In a multivariate analysis, significant survival benefits were noted in younger patients and those with transfusion independence at time of diagnosis. Adjusting for age, gender, time to treatment and transfusion status, the hazard ratio for death for decitabine vs. azacitidine was 1.02 (CI: 0.94-1.11, p=0.65).
Conclusions: This population-based study showed that both azacitidine and decitabine can be considered as equivalent standards of care with comparable survival outcomes for the management of older patients with AML who are unfit for intensive chemotherapy.
Mehra: Janssen: Employment. He: Janssen: Employment. Potluri: SmartAnalyst Inc.: Employment; Janssen: Consultancy, Research Funding. Loefgren: Janssen: Employment.
Asterisk with author names denotes non-ASH members.