Table 1 Demographic and clinical characteristics
Characteristic | Pegfilgrastim 6 mg (n = 101) | Lipegfilgrastim 6 mg (n = 101) | ||
|---|---|---|---|---|
Intent-to-treat/safety population | Per-protocol population | Intent-to-treat/safety population | Per-protocol population | |
Mean age, years (± SD) | 51.1 (9.4) | 50.9 (9.3) | 49.9 (10.1) | 49.3 (10.0) |
Age ≥65 years | 7 (6.9) | 6 (6.4) | 7 (6.9) | 6 (6.4) |
Mean weight, kg (± SD) ≤ | 73.2 (14.6) | 73.6 (14.8) | 73.9 (17.1) | 73 (16.4) |
Gender, n (%) | ||||
Female | 101 (100.0) | 94 (100.0) | 101 (100.0) | 94 (100.0) |
Male | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Country, n (%) | ||||
Russia | 63 (62.4) | 61 (64.9) | 63 (62.4) | 60 (63.8) |
Ukraine | 38 (37.6) | 33 (35.1) | 38 (37.6) | 34 (36.2) |
Reason for chemotherapy, n (%) | ||||
Adjuvant therapy | 74 (73.3) | 70 (74.5) | 75 (74.3) | 71 (75.5) |
Treatment for metastatic disease | 27 (26.7) | 24 (25.5) | 26 (25.7) | 23 (24.5) |
Disease stage, n (%) | ||||
High-risk stage II | 36 (35.6) | 35 (37.2) | 39 (38.6) | 38 (40.4) |
Stage III | 45 (44.6) | 44(46.8) | 48 (47.5) | 46 (48.9) |
Stage IV | 20 (19.8) | 15 (16.0) | 14 (13.9) | 10 (10.6) |
ECOG performance status,* n (%) | ||||
01 | 47 (46.5) | 46 (48.9) | 45 (44.6) | 44 (46.8) |
02 | 54 (53.5) | 48 (51.1) | 56 (55.4) | 50 (53.2) |
03 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Months since first diagnosis | ||||
Mean ± SD | 6.1 ± 26.6 | 4.5 ± 20.3 | 5.3 ± 16.7 | 4.4 ± 15.6 |
Median (range) | 1.0 (0–185.0) | 1.0 (0–185.0) | 2.0 (0–130.0) | 1.0 (0–130.0) |
Breast surgery, n (%) | ||||
Yes | 41 (40.6) | 57 (60.6) | 51 (50.5) | 45 (47.9) |
No | 60 (59.4) | 37 (39.4) | 50 (49.5) | 49 (52.1) |
Months since last surgery | ||||
N with surgery | 60 | 57 | 50 | 45 |
Mean ± SD | 9.1 ± 34.1 | 6.3 ± 25.8 | 6.7 ± 15.5 | 4.9 ± 12.3 |
Median (range) | 1.0 (0–185.0) | 1.0 (0–185) | 1.0 (0–72.0) | 1.0 (0–185) |
Type of breast surgery,† n (%) | ||||
Breast-conserving surgery | 7 (6.9) | 6 (6.4) | 4 (4.0) | 2 (2.1) |
Mastectomy | 55 (54.5) | 52 (55.3) | 46 (45.5) | 43 (45.7) |
Axillary lymphadenectomy | 46 (45.5) | 44 (46.8) | 44 (43.6) | 40 (42.6) |