Table 3.

Five-year survival outcomes in patients with a FLT3-TKD mutation, by NPM1 mutation status and treatment

NPM1mut (n = 79)NPM1WT (n = 55)
PlaceboMidostaurinHR (95% CI)PlaceboMidostaurinHR (95% CI)
OS       
 n 34 45  30 25  
 Estimates at 5 y (95% CI), % 68.9 (54.5-87.0) 70.5 (58.2-85.3) 0.94 (0.41-2.15) 41.4 (26.8-63.8) 51.3 (34.9-75.6) 0.70 (0.34-1.46) 
EFS       
 n 34 45  30 25  
 Estimates at 5 y (95% CI), % 39.7 (26.0-60.7) 55.0 (42.1-71.8) 0.63 (0.34-1.18) 25.7 (13.8-47.8) 22.4 (10.4-48.2) 1.04 (0.57-1.92) 
DFS       
 n 18 34  18 11  
 Estimates at 5 y (95% CI), % 65.3 (48.5-88.0) 71.9 (59.2-87.5) 0.81 (0.32-2.01) 46.4 (29.1-74.2) 54.3 (35.2-83.9) 0.64 (0.26-1.57) 
CIR       
 n 18 34  18 11  
 Estimates at 5 y (95% CI), % 26.1 (24.4-27.9) 17.9 (17.2-18.7) 0.67 (0.23-1.94) 43.7 (41.1-46.2) 45.7 (42.6-48.8) 0.93 (0.37-2.34) 
NPM1mut (n = 79)NPM1WT (n = 55)
PlaceboMidostaurinHR (95% CI)PlaceboMidostaurinHR (95% CI)
OS       
 n 34 45  30 25  
 Estimates at 5 y (95% CI), % 68.9 (54.5-87.0) 70.5 (58.2-85.3) 0.94 (0.41-2.15) 41.4 (26.8-63.8) 51.3 (34.9-75.6) 0.70 (0.34-1.46) 
EFS       
 n 34 45  30 25  
 Estimates at 5 y (95% CI), % 39.7 (26.0-60.7) 55.0 (42.1-71.8) 0.63 (0.34-1.18) 25.7 (13.8-47.8) 22.4 (10.4-48.2) 1.04 (0.57-1.92) 
DFS       
 n 18 34  18 11  
 Estimates at 5 y (95% CI), % 65.3 (48.5-88.0) 71.9 (59.2-87.5) 0.81 (0.32-2.01) 46.4 (29.1-74.2) 54.3 (35.2-83.9) 0.64 (0.26-1.57) 
CIR       
 n 18 34  18 11  
 Estimates at 5 y (95% CI), % 26.1 (24.4-27.9) 17.9 (17.2-18.7) 0.67 (0.23-1.94) 43.7 (41.1-46.2) 45.7 (42.6-48.8) 0.93 (0.37-2.34) 

Estimated Kaplan-Meier rates at 5 years (with 95% CI) and corresponding HR. This analysis was not censored at allogeneic hematopoietic cell transplant. HR <1 indicates a benefit with midostaurin.

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