ISSN: 2578-501X
Authors: Marlies EHM Van Hoef*
Midostaurin is registered for the indication newly diagnosed acute myeloid leukemia that is FLT3 mutation positive in combination with standard cytarabine and daunorubicine induction and cytarabine consolidation. The registration is based on a study of 717 patients that examined the addition of midostaurin 50 mg orally twice daily or placebo to standard induction on days 8 to 21 of a cycle for a maximum of two induction cycles [1]. In case of complete remission patients received four cycles of 28 days cytarabine consolidation with midostaurin 50 mg twice daily on days 8 to 21. Patients who remained in complete remission after consolidation therapy entered a maintenance phase in which patients received midostaurin 50 mg twice daily or placebo for twelve 28 days cycles. The complete remission rate was 58.9% versus 53.5% respectively. Median disease free survival was 26.7 m versus 15.5 months respectively. The 4-years overall survival was 51.4% and 44.3% respectively. The median overall survival was 74.4 months versus 25.6 months respectively. This difference was explained by the inflection rates of the Kaplan Meyer curves. The hazard ratio for death 0.78 (95% CI 0.63-0.96) reflected the magnitude of the benefit.
Keywords: Leukemia; cytarabine; midostaurin
