Table 5.

Treatment response of AML patients categorized according to 2017 ELN genetic risk classification

End pointFavorableIntermediateAdverse
Arm A: G3139Arm B: controlP*Arm A: G3139Arm B: controlP*Arm A: G3139Arm B: controlP*
CR   .38   .37   .36 
 Events/n 31/39 24/34  14/24 8/18  26/67 33/71  
 Rate (95% CI) 0.79 (0.67-0.92) 0.71 (0.56-0.86)  0.58 (0.39-0.78) 0.44 (0.21-0.67)  0.39 (0.27-0.50) 0.46 (0.35-0.58)  
OS   .54   .30   .34 
 Events/n 26/39 28/34  22/24 17/18  66/67 71/71  
 Median (95% CI), mo 15 (8.84-74.54) 18 (13.96-33.41)  9 (5.12-10.91) 5 (1.22-7.82)  5 (3.29-6.87) 6 (4.34-8.67)  
 1-y rate (95% CI) 0.54 (0.37-0.68) 0.74 (0.55-0.85)  0.31 (0.14-0.50) 0.22 (0.07-0.43)  0.21 (0.12-0.31) 0.25 (0.16-0.36)  
 2-y rate (95% CI) 0.38 (0.24-0.53) 0.41 (0.25-0.57)  0.22 (0.08-0.40) 0.06 (0-0.22)  0.06 (0.02-0.13) 0.10 (0.04-0.18)  
EFS   .56   .57   .25 
 Events/n 28/39 28/34  23/24 17/18  66/67 71/71  
 Median (95% CI), mo 9 (2.07-14.98) 9 (1.97-19.65)  2 (1.38-6.57) 2 (1.12-2.83)  2 (1.41-1.97) 2 (1.48-2.56)  
 1-y rate (95% CI) 0.36 (0.21-0.51) 0.44 (0.27-0.60)  0.14 (0.04-0.31) 0.11 (0.02-0.30)  0.06 (0.02-0.13) 0.15 (0.08-0.25)  
 2-y rate (95% CI) 0.33 (0.19-0.48) 0.26 (0.13-0.42)  0.09 (0.02-0.25) 0.06 (0-0.22)  0.03 (0.01-0.07) 0.07 (0.03-0.15)  
DFS   .83   .51   .42 
 Events/n 20/31 18/24  13/14 7/8  25/26 33/33  
 Median (95% CI), mo 14 (7.03 to ∞) 19 (7.33-41.13)  5 (1.28-7.16) 6 (1.65-14.45)  5 (3.22-6.18) 8 (4.60-11.96)  
 1-y rate (95% CI) 0.52 (0.33-0.67) 0.63 (0.40-0.78)  0.16 (0.03-0.39) 0.25 (0.04-0.56)  0.15 (0.05-0.31) 0.33 (0.18-0.49)  
 2-y rate (95% CI) 0.42 (0.25-0.58) 0.42 (0.22-0.60)  0.16 (0.03-0.39) 0.13 (0.01-0.42)  0.08 (0.01-0.22) 0.12 (0.04-0.26)  
Early death rate during first 30 d of induction therapy   .84   .17   .53 
 All patients (95% CI) 0.10 (0.01-0.20) 0.09 (0-0.18)  0.04 (0-0.12) 0.17 (0-0.34)  0.16 (0.08-0.25) 0.13 (0.05-0.20)  
End pointFavorableIntermediateAdverse
Arm A: G3139Arm B: controlP*Arm A: G3139Arm B: controlP*Arm A: G3139Arm B: controlP*
CR   .38   .37   .36 
 Events/n 31/39 24/34  14/24 8/18  26/67 33/71  
 Rate (95% CI) 0.79 (0.67-0.92) 0.71 (0.56-0.86)  0.58 (0.39-0.78) 0.44 (0.21-0.67)  0.39 (0.27-0.50) 0.46 (0.35-0.58)  
OS   .54   .30   .34 
 Events/n 26/39 28/34  22/24 17/18  66/67 71/71  
 Median (95% CI), mo 15 (8.84-74.54) 18 (13.96-33.41)  9 (5.12-10.91) 5 (1.22-7.82)  5 (3.29-6.87) 6 (4.34-8.67)  
 1-y rate (95% CI) 0.54 (0.37-0.68) 0.74 (0.55-0.85)  0.31 (0.14-0.50) 0.22 (0.07-0.43)  0.21 (0.12-0.31) 0.25 (0.16-0.36)  
 2-y rate (95% CI) 0.38 (0.24-0.53) 0.41 (0.25-0.57)  0.22 (0.08-0.40) 0.06 (0-0.22)  0.06 (0.02-0.13) 0.10 (0.04-0.18)  
EFS   .56   .57   .25 
 Events/n 28/39 28/34  23/24 17/18  66/67 71/71  
 Median (95% CI), mo 9 (2.07-14.98) 9 (1.97-19.65)  2 (1.38-6.57) 2 (1.12-2.83)  2 (1.41-1.97) 2 (1.48-2.56)  
 1-y rate (95% CI) 0.36 (0.21-0.51) 0.44 (0.27-0.60)  0.14 (0.04-0.31) 0.11 (0.02-0.30)  0.06 (0.02-0.13) 0.15 (0.08-0.25)  
 2-y rate (95% CI) 0.33 (0.19-0.48) 0.26 (0.13-0.42)  0.09 (0.02-0.25) 0.06 (0-0.22)  0.03 (0.01-0.07) 0.07 (0.03-0.15)  
DFS   .83   .51   .42 
 Events/n 20/31 18/24  13/14 7/8  25/26 33/33  
 Median (95% CI), mo 14 (7.03 to ∞) 19 (7.33-41.13)  5 (1.28-7.16) 6 (1.65-14.45)  5 (3.22-6.18) 8 (4.60-11.96)  
 1-y rate (95% CI) 0.52 (0.33-0.67) 0.63 (0.40-0.78)  0.16 (0.03-0.39) 0.25 (0.04-0.56)  0.15 (0.05-0.31) 0.33 (0.18-0.49)  
 2-y rate (95% CI) 0.42 (0.25-0.58) 0.42 (0.22-0.60)  0.16 (0.03-0.39) 0.13 (0.01-0.42)  0.08 (0.01-0.22) 0.12 (0.04-0.26)  
Early death rate during first 30 d of induction therapy   .84   .17   .53 
 All patients (95% CI) 0.10 (0.01-0.20) 0.09 (0-0.18)  0.04 (0-0.12) 0.17 (0-0.34)  0.16 (0.08-0.25) 0.13 (0.05-0.20)  
*

P values for CR from χ2 test; for time-to-event variables, from log-rank test.

View Large