Table 1.
Demographics and disease characteristics
Pegfilgrastim 6 mg | Filgrastim 5 μg/kg/day | |
No. of Patients | 42 | 41 |
Age | ||
Median (range), years | 51 (18–74) | 54 (19–79) |
< 55 years, n (%) | 22 (52%) | 21 (51%) |
≥ 55 years, n (%) | 20 (48%) | 20 (49%) |
Male, n (%) | 22 (52%) | 17 (41%) |
Baseline ANC, × 109/L | ||
Mean (SD) | 2.2 (5.4) | 2.3 (4.0) |
Median (range) | 0.4 (0.0–33.8) | 1.0 (0.0–17.4) |
Most common FAB Type, n (%) | ||
M1 | 9 (21%) | 9 (22%) |
M2 | 8 (19%) | 11 (27%) |
M4 | 12 (29%) | 4 (10%) |
M4eo | 3 (7%) | 3 (7%) |
M5 | 4 (10%) | 6 (15%) |
Cytogenetics, n (%) | ||
Intermediate | 34 (81%) | 38 (93%) |
Favorable | 7 (17%) | 3 (7%) |
Unfavorablea | 1 (2%) | 0 (0%) |
Bone marrow cellularity, n (%) | ||
Hypoplastic | 4 (10%) | 5 (12%) |
Normoplastic | 4 (10%) | 8 (20%) |
Hyperplastic | 33 (79%) | 28 (68%) |
Unknown | 1 (2%) | 0 (0%) |
ANC, absolute neutrophil count; SD, standard deviation; FAB, French American British.
aCytogenetic classification re-evaluated after randomization; patient ineligible, but included in analyses consistent with intent-to-treat principles.