Patient and disease characteristics
| . | AMLSG 16-10 . | Historical controls . | P . |
|---|---|---|---|
| . | n = 440 . | n = 415 . | . |
| Age, y | <.001 | ||
| Median (range) | 54.1 (18-70) | 50.5 (18-70) | |
| Sex, n (%) | .37 | ||
| Male | 191 (43) | 193 (46) | |
| Female | 249 (57) | 222 (54) | |
| ECOG PS, n (%) | <.0001 | ||
| 0 | 169 (38) | 92 (22) | |
| 1 | 218 (50) | 255 (62) | |
| 2 | 53 (12) | 68 (16) | |
| WBC, 109/L | .40 | ||
| Median (range) | 41.8 (0.3-420) | 44.8 (0.2-439) | |
| Missing | 3 | 3 | |
| Hemoglobin, g/dL | .79 | ||
| Median (range) | 9.0 (4.1-18.1) | 9.0 (3.1-16.6) | |
| Missing | 4 | 3 | |
| Platelets, 109/L | .37 | ||
| Median (range) | 59 (5-681) | 58 (6-734) | |
| Missing | 3 | 2 | |
| BM blasts, % | .22 | ||
| Median (range) | 80 (0-100) | 85 (2-100) | |
| Missing | 46 | 25 | |
| PB blasts, % | .08 | ||
| Median (range) | 52 (0-100) | 60 (0-100) | |
| Missing | 30 | 20 | |
| AML type, n (%) | <.0001 | ||
| De novo | 390 (89) | 396 (96) | |
| Secondary | 31 (7) | 6 (1) | |
| Therapy-related | 19 (4) | 12 (3) | |
| Missing | — | 1 | |
| Cytogenetics, n (%)* | .02 | ||
| Intermediate I | 285 (69) | 321 (78) | |
| Intermediate II | 101 (25) | 72 (17) | |
| Adverse | 26 (6) | 22 (5) | |
| Missing | 28 | 0 | |
| FLT3-ITD, n (%) | .67 | ||
| Allelic ratio <0.5 | 196 (45) | 129 (44) | |
| Allelic ratio ≥0.5 | 242 (55) | 165 (56) | |
| Missing | 2 | 121 | |
| FLT3-TKD,† n (%) | .86 | ||
| Yes | 16 (4) | 16 (4) | |
| No | 424 (96) | 377 (96) | |
| Missing | — | 22 | |
| Mutated NPM1, n (%) | .24 | ||
| Yes | 266 (60) | 229 (56) | |
| No | 174 (40) | 178 (44) | |
| Missing | — | 8 |
| . | AMLSG 16-10 . | Historical controls . | P . |
|---|---|---|---|
| . | n = 440 . | n = 415 . | . |
| Age, y | <.001 | ||
| Median (range) | 54.1 (18-70) | 50.5 (18-70) | |
| Sex, n (%) | .37 | ||
| Male | 191 (43) | 193 (46) | |
| Female | 249 (57) | 222 (54) | |
| ECOG PS, n (%) | <.0001 | ||
| 0 | 169 (38) | 92 (22) | |
| 1 | 218 (50) | 255 (62) | |
| 2 | 53 (12) | 68 (16) | |
| WBC, 109/L | .40 | ||
| Median (range) | 41.8 (0.3-420) | 44.8 (0.2-439) | |
| Missing | 3 | 3 | |
| Hemoglobin, g/dL | .79 | ||
| Median (range) | 9.0 (4.1-18.1) | 9.0 (3.1-16.6) | |
| Missing | 4 | 3 | |
| Platelets, 109/L | .37 | ||
| Median (range) | 59 (5-681) | 58 (6-734) | |
| Missing | 3 | 2 | |
| BM blasts, % | .22 | ||
| Median (range) | 80 (0-100) | 85 (2-100) | |
| Missing | 46 | 25 | |
| PB blasts, % | .08 | ||
| Median (range) | 52 (0-100) | 60 (0-100) | |
| Missing | 30 | 20 | |
| AML type, n (%) | <.0001 | ||
| De novo | 390 (89) | 396 (96) | |
| Secondary | 31 (7) | 6 (1) | |
| Therapy-related | 19 (4) | 12 (3) | |
| Missing | — | 1 | |
| Cytogenetics, n (%)* | .02 | ||
| Intermediate I | 285 (69) | 321 (78) | |
| Intermediate II | 101 (25) | 72 (17) | |
| Adverse | 26 (6) | 22 (5) | |
| Missing | 28 | 0 | |
| FLT3-ITD, n (%) | .67 | ||
| Allelic ratio <0.5 | 196 (45) | 129 (44) | |
| Allelic ratio ≥0.5 | 242 (55) | 165 (56) | |
| Missing | 2 | 121 | |
| FLT3-TKD,† n (%) | .86 | ||
| Yes | 16 (4) | 16 (4) | |
| No | 424 (96) | 377 (96) | |
| Missing | — | 22 | |
| Mutated NPM1, n (%) | .24 | ||
| Yes | 266 (60) | 229 (56) | |
| No | 174 (40) | 178 (44) | |
| Missing | — | 8 |