Table 1.
Standard Arm (n = 115) |
Tosedostat 120 mg (n = 116) |
Total | |
---|---|---|---|
Sex | |||
M | 72 (63%) | 76 (66%) | 148 (64%) |
F | 43 (37%) | 40 (34%) | 83 (36%) |
Age groups | |||
≤70 years | 72 (63%) | 64 (55%) | 136 (59%) |
>70 years | 43 (37%) | 52 (45%) | 95 (41%) |
Age | |||
Mean; SD | 69.9; 3.26 | 70.7; 3.75 | 70.3; 3.53 |
Median; range | 69; 66–79 | 70; 66–81 | 70; 66–81 |
WHO performance | |||
0 | 63 (55%) | 54 (47%) | 117 (51%) |
1 | 43 (37%) | 50 (43%) | 93 (40%) |
2 | 8 (7%) | 11 (9%) | 19 (8%) |
NA | 1 (1%) | 1 (1%) | 2 (1%) |
Diagnosis | |||
MDS | 15 (13%) | 16 (14%) | 31 (13%) |
AML | 100 (87%) | 100 (86%) | 200 (87%) |
Prior HM | |||
No | 109 (95%) | 106 (93%) | 215 (94%) |
Yes | 6 (5%) | 8 (7%) | 14 (6%) |
AML risk group (acc. to HOVON 103 protocol) * | |||
Good | 8 (7%) | 2 (2%) | 10 (4%) |
Intermediate | 35 (30%) | 39 (34%) | 74 (32%) |
Poor | 60 (52%) | 57 (49%) | 117 (51%) |
Very poor | 12 (10%) | 18 (16%) | 30 (13%) |
NPM1 mutation | |||
Neg | 51 (44%) | 53 (46%) | 104 (45%) |
Pos | 19 (17%) | 19 (16%) | 38 (16%) |
NA | 45 (39%) | 44 (38%) | 89 (39%) |
FLT3ITD | |||
Neg | 60 (52%) | 67 (58%) | 127 (55%) |
Pos | 12 (10%) | 7 (6%) | 19 (8%) |
NA | 43 (37%) | 42 (36%) | 85 (37%) |
FLT3 TKD835 | |||
Neg | 33 (29%) | 31 (27%) | 64 (28%) |
Pos | 2 (2%) | 3 (3%) | 5 (2%) |
NA | 80 (70%) | 82 (71%) | 162 (70%) |
EVI1 overexpression | |||
Neg | 65 (57%) | 61 (53%) | 126 (55%) |
Pos | 8 (7%) | 11 (9%) | 19 (8%) |
NA | 42 (37%) | 44 (38%) | 86 (37%) |
CEBPA DM | |||
Neg | 63 (55%) | 68 (59%) | 131 (57%) |
Pos | 4 (3%) | 2 (2%) | 6 (3%) |
NA | 48 (42%) | 46 (40%) | 94 (41%) |
FLT3ITD × NPM1 mutation | |||
Pos × Pos | 9 (8%) | 5 (4%) | 14 (6%) |
Pos × neg | 3 (3%) | 1 (1%) | 4 (2%) |
Neg × Pos | 10 (9%) | 14 (12%) | 24 (10%) |
Neg × Neg | 47 (41%) | 50 (43%) | 97 (42%) |
NA | 46 (40%) | 46 (40%) | 92 (40%) |
HM: Hematological Malignancy; NA: Not available; * see Table S1.