HealthDay News — For patients with acute myeloid leukemia (AML) and a FLT3 mutation, midostaurin plus chemotherapy is associated with prolonged overall and event-free survival, according to a study published online June 23 in the New England Journal of Medicine.
Richard M. Stone, MD, from the Dana-Farber Cancer Institute in Boston, and colleagues screened 3,277 patients aged 18 to 59 years with newly diagnosed AML for FLT3 mutations. Patients were randomized to receive either standard chemotherapy plus midostaurin or placebo; those who were in remission after consolidation therapy entered a maintenance phase with midostaurin or placebo. Randomization was stratified according to FLT3 mutation subtype.
Three hundred sixty patients were randomized to the midostaurin group and 357 to the placebo group. The researchers found that overall survival was significantly longer in the midostaurin versus the placebo group (hazard ratio for death, 0.78), as was event-free survival (hazard ratio for event or death, 0.78). The benefit of midostaurin was consistent across all FLT3 subgroups in the primary analysis and in an analysis in which data for patients who underwent transplantation were censored.
“The addition of the multitargeted kinase inhibitor midostaurin to standard chemotherapy significantly prolonged overall and event-free survival among patients with AML and a FLT3 mutation,” the authors write.
The study was partially funded by Novartis, the manufacturer of midostaurin.