Baseline patient and leukemia characteristics
| Variables . | Sorafenib (n = 65) . | Placebo (n = 33) . | P . |
|---|---|---|---|
| Age, median (range), y | 49 (18-65) | 50 (20-65) | .67 |
| Sex, n (%) | .73 | ||
| Female | 37 (57) | 20 (61) | |
| Male | 28 (43) | 13 (39) | |
| AML type, n∗ (%) | .46 | ||
| De novo | 62 (95) | 33 (100) | |
| Secondary | 2 (3) | 0 | |
| White cell count × 109/L, median (IQR) | 35.7 (12.8-79.4) | 33.1 (12.9-63.1) | .64 |
| Platelet count × 109/L, median (IQR) | 61 (43-79) | 52 (33-89) | .78 |
| MRC cytogenetic risk, n (%) | .79 | ||
| Favorable | 2 (3) | 1 (3) | |
| Intermediate | 61 (94) | 32 (97) | |
| Adverse | 1 (1) | 0 | |
| Not available | 1 (1) | 0 | |
| FLT3-ITD allelic ratio, median (range) | 0.46 (0.05-5.8) | 0.52 (0.05-8.4) | .53 |
| FLT3-ITD allelic ratio, n (%) | .36 | ||
| <0.5 | 36 (55) | 15 (45) | |
| ≥0.5 to <0.7 | 10 (15) | 9 (27) | |
| ≥0.7 | 19 (29) | 9 (27) | |
| FLT3-ITD length (base pairs)†, median (range) | 43.5 (15-282) | 45 (18-195) | .8 |
| FLT3-ITD insertion site† , n (%) | |||
| Juxtamembrane domain | 124 (74) | 44 (71) | |
| TKD1 β1-sheet | 27 (16) | 15 (24) | |
| TKD1 nucleotide binding loop | 3 (2) | 2 (3) | |
| TKD1 β2-sheet | 13 (8) | 1 (2) | |
| NPM1 detected, n/total available (%) | 30/50 (60) | 22/27 (81) | .07 |
| Variables . | Sorafenib (n = 65) . | Placebo (n = 33) . | P . |
|---|---|---|---|
| Age, median (range), y | 49 (18-65) | 50 (20-65) | .67 |
| Sex, n (%) | .73 | ||
| Female | 37 (57) | 20 (61) | |
| Male | 28 (43) | 13 (39) | |
| AML type, n∗ (%) | .46 | ||
| De novo | 62 (95) | 33 (100) | |
| Secondary | 2 (3) | 0 | |
| White cell count × 109/L, median (IQR) | 35.7 (12.8-79.4) | 33.1 (12.9-63.1) | .64 |
| Platelet count × 109/L, median (IQR) | 61 (43-79) | 52 (33-89) | .78 |
| MRC cytogenetic risk, n (%) | .79 | ||
| Favorable | 2 (3) | 1 (3) | |
| Intermediate | 61 (94) | 32 (97) | |
| Adverse | 1 (1) | 0 | |
| Not available | 1 (1) | 0 | |
| FLT3-ITD allelic ratio, median (range) | 0.46 (0.05-5.8) | 0.52 (0.05-8.4) | .53 |
| FLT3-ITD allelic ratio, n (%) | .36 | ||
| <0.5 | 36 (55) | 15 (45) | |
| ≥0.5 to <0.7 | 10 (15) | 9 (27) | |
| ≥0.7 | 19 (29) | 9 (27) | |
| FLT3-ITD length (base pairs)†, median (range) | 43.5 (15-282) | 45 (18-195) | .8 |
| FLT3-ITD insertion site† , n (%) | |||
| Juxtamembrane domain | 124 (74) | 44 (71) | |
| TKD1 β1-sheet | 27 (16) | 15 (24) | |
| TKD1 nucleotide binding loop | 3 (2) | 2 (3) | |
| TKD1 β2-sheet | 13 (8) | 1 (2) | |
| NPM1 detected, n/total available (%) | 30/50 (60) | 22/27 (81) | .07 |
IQR, interquartile range; MRC, Medical Research Council; TKD1, tyrosine kinase domain 1.
One patient in the sorafenib group with insufficient information for the AML type to be assigned.
Diagnostic DNA available for FLT3-ITD NGS for 52 patients in the sorafenib group and 28 patients in the placebo group.