Parameter | Oral azacitidine (N = 236) | Placebo (N = 233) |
---|---|---|
Age, years, median (range) | 68 (55‒86) | 68 (55‒82) |
ECOG PS score, n (%) | Â | Â |
0 | 116 (49.2) | 111 (47.6) |
1 | 99 (41.9) | 105 (45.1) |
2‒3 | 21 (8.9) | 17 (7.3) |
De novo AML, n (%) | 211 (89.4) | 215 (92.3) |
WHO AML classification, n (%) | Â | Â |
Not otherwise specified | 147 (62.3) | 144 (61.8) |
Myelodysplasia-related changes | 49 (20.8) | 42 (18.0) |
Recurrent genetic abnormalities | 38 (16.1) | 46 (19.7) |
Therapy-related | 2 (0.8) | 0 |
NCCN cytogenetic risk at diagnosis, n (%) | Â | Â |
Intermediate | 202 (85.6) | 202 (86.7) |
Poor | 34 (14.4) | 31 (13.3) |
Response after induction, n (%) | Â | Â |
CR | 185 (78.4) | 197 (84.5) |
Cri | 51 (21.6) | 36 (15.5) |
Received consolidation, n (%) | Â | Â |
Yes | 184 (78.0) | 191 (82.0) |
1 cycle | 110 (46.6) | 101 (43.3) |
2 cycles | 69 (29.2) | 77 (33.0) |
3 cycles | 5 (2.1) | 13 (5.6) |
No | 52 (22.0) | 42 (18.0) |
Reason ineligible for transplanta | Â | Â |
Age | 154 (65) | 152 (65) |
Comorbidities | 52 (22) | 50 (21) |
Performance status | 14 (6) | 9 (4) |
No available donor | 37 (16) | 35 (15) |
Patient decision | 19 (8) | 32 (14) |
Unfavorable cytogenetics | 6 (3) | 10 (4) |
Other | 28 (12) | 21 (9) |
Time from induction to randomization, months, median (range) | 3.9 (1.4‒8.8) | 4.0 (1.3‒15.1) |
Time from CR/CRi to randomization, days, median (range) | 84 (7‒154b) | 86 (7‒263b) |
Bone marrow blasts, percent, median (range) | 2.0 (0.0‒5.0) | 2.0 (0.0‒6.5c) |
MRD + at randomization,d n (%) | 102 (43.2) | 115 (49.4) |
ANC, 109/L, median (range) | 3.0 (0.3b‒15.9) | 2.8 (0.5‒9.6) |
Hemoglobin, g/dL, median (range) | 11.3 (7.5‒15.9) | 10.8 (7.7‒14.9) |
Platelets, 109/L, median (range) | 154 (22‒801) | 179 (16b‒636) |
WBC, 109/L, median (range) | 4.9 (0.8‒18.7) | 4.5 (1.3‒12.6) |