Patient characteristics
| . | Observation group (N = 60) . | Azacitidine group (N = 56) . |
|---|---|---|
| Sex, male/female | 33/27 (55%/45%) | 35/21 (63%/37%) |
| Age, median/range | 69/60-79 | 69/64-81 |
| WHO performance | ||
| WHO 0 | 23 (38%) | 29 (52%) |
| WHO 1 | 34 (57%) | 17 (30%) |
| WHO 2 | — | 5 (9%) |
| Unknown | 3 (5%) | 5 (9%) |
| Unfavorable risk cytogenetic abnormalities at diagnosis* | 14 (23%) | 9 (16%) |
| CR(i) obtained after | ||
| Induction cycle 1 | 45 (75%) | 35 (63%) |
| Induction cycle 2 | 15 (25%) | 21 (37%) |
| Platelet count ≥100 × 109/L | 45 (75%) | 38 (68%) |
| Neutrophils, ×109/L | ||
| Median | 4.1 | 3.3 |
| Range | 1.5-38 | 0.6-13.7 |
| CR | 45 (75%) | 37 (66%) |
| MDS-refractory anemia with excess of blasts | 6 (10%) | 6 (11%) |
| . | Observation group (N = 60) . | Azacitidine group (N = 56) . |
|---|---|---|
| Sex, male/female | 33/27 (55%/45%) | 35/21 (63%/37%) |
| Age, median/range | 69/60-79 | 69/64-81 |
| WHO performance | ||
| WHO 0 | 23 (38%) | 29 (52%) |
| WHO 1 | 34 (57%) | 17 (30%) |
| WHO 2 | — | 5 (9%) |
| Unknown | 3 (5%) | 5 (9%) |
| Unfavorable risk cytogenetic abnormalities at diagnosis* | 14 (23%) | 9 (16%) |
| CR(i) obtained after | ||
| Induction cycle 1 | 45 (75%) | 35 (63%) |
| Induction cycle 2 | 15 (25%) | 21 (37%) |
| Platelet count ≥100 × 109/L | 45 (75%) | 38 (68%) |
| Neutrophils, ×109/L | ||
| Median | 4.1 | 3.3 |
| Range | 1.5-38 | 0.6-13.7 |
| CR | 45 (75%) | 37 (66%) |
| MDS-refractory anemia with excess of blasts | 6 (10%) | 6 (11%) |
All characteristics were obtained from randomization except unfavorable risk cytogenetic abnormalities, which were obtained at diagnosis.
−7, −7q, −5, −5q, abn 3q, complex ≥3 abnormalities.