Article Text
Abstract
Background Acute myeloid leukaemia (AML) is the most frequent adult leukaemia. Hypomethylating agents such as azacitidine or decitabine are indicated for patients not eligible to receive intensive treatment (patients >65 years of age, which represents about 70% of the total AML cases).
Purpose To compare treatment costs for azacitidine and decitabine in adult AML patients, taking into consideration the stability of reconstituted vials as well as the use of vial sharing strategies.
Material and methods Analysis of published stability studies and clinical trials assessing azacitidine in older patients with newly diagnosed AML with >30% blasts (AZA-AML-001 study) and decitabine (DACO-16 and 17 studies—phase III and II, respectively) in the management of AML was undertaken.
Results Mean number of received cycles: 4 for decitabine, 20 mg/m2 for 5 days, and 6 cycles for azacitidine, 75 mg/m2 for 7 days (28 day cycles in both cases). Reconstituted and diluted in a compatible fluid (NaCl 0.9% or dextrose 5%) decitabine bags can be kept in cold storage (2–8 °C) for 3 hours, plus 1 hour at room temperature (20–25°C) prior to administration, making vial sharing not feasible. Polypropylene azacitidine 25 mg/mL solutions were stable for 8 days at −20°C, allowing vial sharing.
The costs per vial were decitabine 50 mg vial, €1109; azacitidine 100 mg vial, €299. Assuming a standard body surface of 1.75m2, each decitabine cycle (5 days) costs €5545 (€22 180 for a mean of 4 cycles), while the cost of each azacitbine cycle (7 days) was €2747 (€16 482 for a mean of 6 cycles).
Conclusion Whereas published studies report similar efficacy between both drugs, treatment with azacitidine resulted in savings of €5698 per treated patient.
References and/or acknowledgements Kantarjian HM, Thomas XG, Dmoszynska A, et al. Multicentre, randomised, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukaemia. J Clin Oncol2012;30:2670–7.
Dombret H, Seymour JF, Butrym A, et al. International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts. Blood2015;126.
No conflict of interest