Multinational randomized crossover study of oral decitabine/cedazuridine versus intravenous decitabine for acute myeloid leukemia

A multinational study compared decitabine exposure when administered intravenously (DEC-IV) for 5 days versus orally administered decitabine with cedazuridine (DEC-C) in patients with acute myeloid leukemia (AML) who were ineligible for intensive induction chemotherapy. In all, 87 patients were randomized 1:1 to DEC-IV or oral DEC-C (days 1-5 in a 28-day treatment cycle), followed by 5 days of the other formulation in the next treatment cycle. All patients received oral DEC-C in subsequent cycles until treatment discontinuation. Equivalent systemic decitabine exposures were observed (5-day AUC ratio between the two decitabine formulations of 99.64% (90% CI 91.23-108.80). Demethylation rates also were similar (≤ 1.1% difference). Median overall survival, clinical respose, and safety profile with oral DEC-C were consistent with those previous observed with DEC-IV. The authors conclude that the findings support the use of oral DEC-C in patients with AML (graphical abstract).