Background
Results
Baseline characteristics of the study population
All patients (N=213) | Azacitidine (N=26) | Intensive chemotherapy (N=90) | BSC (N=97) | P-value | ||
---|---|---|---|---|---|---|
Overall | Aza vs IC | |||||
Age
| ||||||
Median (range) | 68 (60–96) | 70 (60–81) | 66 (60–74) | 71 (60–96) | <0.001 | <0.001 |
≥ 70 years | 80 (38%) | 14 (54%) | 10 (11%) | 56 (58%) | <0.001 | <0.001 |
Sex
| 0.48 | 0.27 | ||||
Male | 119 (56%) | 17 (65%) | 47 (52%) | 55 (57%) | ||
Performance score
| <0.001 | 0.002 | ||||
≥ 2 | 121 (59%) | 5 (19%) | 47 (54%) | 69 (75%) | ||
HCT-comorbidity index
| <0.001 | 0.029 | ||||
Low (0) | 98 (46%) | 9 (35%) | 57 (63%) | 32 (33%) | ||
Intermediate (1–2) | 66 (31%) | 8 (31%) | 18 (20%) | 40 (41%) | ||
High (> 2) | 49 (23%) | 9 (35%) | 15 (17%) | 25 (26%) | ||
AML FAB classification
| 0.27 | 0.28 | ||||
M0/M1 | 41 (20%) | 4 (17%) | 21 (21%) | 16 (19%) | ||
M2 | 87 (42%) | 8 (33%) | 40 (40%) | 39 (47%) | ||
M4/M5 | 51 (25%) | 11 (46%) | 22 (22%) | 18 (22%) | ||
M6/M7 | 13 (6%) | 1 (4%) | 4 (4%) | 8 (10%) | ||
AML type
| 0.089 | 0.056 | ||||
De novo | 139 (65%) | 13 (50%) | 65 (72%) | 61 (63%) | ||
Secondary | 74 (35%) | 13 (50%) | 25 (28%) | 36 (37%) | ||
Bone marrow blasts
| ||||||
Median (range) | 45 (16–100) | 27 (20–88) | 52 (20–100) | 47 (16–93) | <0.001 | <0.001 |
≥ 30% | 135 (70%) | 11 (42%) | 67 (77%) | 57 (72%) | 0.003 | 0.001 |
WBC
| ||||||
Median (range) | 5 (0–360) | 3 (0–15) | 5 (1–236) | 7 (1–360) | 0.13 | <0.001 |
≥ 15 × 109/l | 65 (31%) | 0 (0%) | 31 (34%) | 34 (35%) | 0.002 | <0.001 |
LDH
| ||||||
Median (range) | 324 (116–4835) | 259 (136–1133) | 340 (134–2664) | 332 (116–4835) | 0.15 | 0.092 |
> 600 U/l | 49 (23%) | 2 (8%) | 21 (23%) | 26 (27%) | 0.13 | 0.15 |
Cytogenetic risk
| 0.003 | 0.48 | ||||
Favourable | 8 (4%) | 0 (0%) | 4 (4%) | 4 (4%) | ||
Intermediate | 135 (63%) | 18 (69%) | 62 (69%) | 55 (57%) | ||
Unfavourable | 47 (22%) | 8 (31%) | 21 (23%) | 18 (19%) | ||
Not available | 23 (11%) | 0 (0%) | 3 (3%) | 20 (21%) | ||
Molecular markers
| 0.27 | 0.45 | ||||
NPMc+/ITD- | 13 (7%) | 1 (4%) | 9 (11%) | 3 (4%) | ||
Others | 163 (93%) | 23 (96%) | 75 (89%) | 65 (96%) |
Response
Azacitidine (N=26) | Intensive chemotherapy (N=90) | P-value | |||
---|---|---|---|---|---|
All (N=90) | Excl. allo-SCT (N = 76) | Aza vs all IC | Aza vs IC excl. allo-SCT | ||
Overall survival
| |||||
1-year | 57% | 56% | 50% | 0.931 | 0.801 |
2-year | 35% | 35% | 31% | 0.921 | 0.501 |
Response, overall
|
11 (42%)
|
68 (76%)
|
54 (71%)
| <0.001 | 0.005 |
CR | 9 (35%) | 63 (70%) | 49 (65%) | ||
PR | 2 (8%) | 5 (6%) | 5 (7%) | ||
No CR or PR | 15 (58%) | 22 (24%) | 22 (29%) | ||
Early death
| |||||
within 4 weeks | 1 (4%) | 4 (4%) | 4 (4%) | 0.881 | 0.791 |
within 8 weeks | 2 (8%) | 11 (12%) | 11 (12%) | 0.511 | 0.401 |
Relapse/death after response
| |||||
within 1 year | 4 (36%) | 39 (57%) | 34 (63%) | 0.211 | 0.181 |
within 2 years | 5 (45%) | 42 (62%) | 37 (69%) | 0.301 | 0.141 |
Days in hospital, median (range) | |||||
month 1–3 | 0.5 (0–30) | 56 (2–85) | 54 (2–85) | <0.001 | 0.029 |
month 4–6 | 0 (0–8) | 0 (0–81) | 0 (0–81) | 0.036 | 0.006 |
RBC transfusions, median per month (range) | |||||
month 1–3 | 2.7 (0–10) | 7 (0–32) | 7 (0–32) | <0.001 | <0.001 |
month 4–6 | 0 (0–13) | 1 (0–8) | 0 (0–8) | 0.97 | 0.65 |
PLT transfusions, median per month (range) | |||||
month 1–3 | 0.3 (0–7) | 5 (0–19) | 5 (0–19) | <0.001 | <0.001 |
month 4–6 | 0 (0–1) | 0 (0–8) | 0 (0–8) | 0.016 | 0.047 |