Dr. Steensma on Midostaurin for Patients With AML

David P. Steensma, MD, senior physician, associate professor of Medicine, Harvard Medical School, Dana-Farber Cancer Institute, discusses a phase III study comparing midostaurin with placebo in combination with daunorubicin cytarabine induction, high-dose cytarabine consolidation, and as maintenance therapy in newly diagnosed patients with acute myeloid leukemia (AML) with FLT3 mutations.

This randomized, double-blind, placebo-controlled study examined midostaurin in patients aged 18 to 60. Patients were randomized to midostaurin plus daunorubicin cytarabine induction or placebo plus cytarabine induction. Patients who received midostaurin had an overall survival (OS) of 74.7 months versus 26.0 months with placebo (HR, 0.77). Median OS data that were censored for stem cell transplant were not available; however, the hazard ratio for the censored group was the same as the uncensored data (HR, 0.77). It is rare to observe an OS benefit in AML, Steensma adds.

Several patients followed the therapy with stem cell transplantation, he explains. Adverse events were fairly similar between the two arms, suggesting that this could potentially be a new treatment regimen for patients with AML.

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