Table 1 Patient demographics and baseline characteristics (intent-to-treat population)
Characteristic | Placebo (n = 125) | Lipegfilgrastim 6 mg SC (n = 250) |
|---|---|---|
Age, years | ||
Mean ± SD | 58.7 ± 8.5 | 58.2 ± 8.5 |
≤64, n (%) | 94 (75.2) | 193 (77.2) |
65–74, n (%) | 29 (23.2) | 54 (21.6) |
≥75, n (%) | 2 (1.6) | 3 (1.2) |
Weight, kg | ||
Mean ± SD | 70.4 ± 13.4 | 69.0 ± 12.9 |
≤60, n (%) | 34 (27.2) | 70 (28.0) |
>60 to ≤75, n (%) | 53 (42.4) | 106 (42.4) |
>75, n (%) | 38 (30.4) | 74 (29.6) |
Sex, n (%) | ||
Female | 20 (16.0) | 30 (12.0) |
Male | 105 (84.0) | 220 (88.0) |
Region, n (%) | ||
Russia | 54 (43.2) | 106 (42.4) |
Ukraine | 38 (30.4) | 77 (30.8) |
Rest of Europe | 33 (26.4) | 67 (26.8) |
NSCLC stage at enrolment, n (%) | ||
Stage IIIB | 49 (39.2) | 97 (38.8) |
Stage IV | 76 (60.8) | 152 (60.8) |
Unknown | 0 (0) | 1 (0.4) |
Time since diagnosis, months | ||
Mean ± SD | 3.4 ± 9.1 | 2.4 ± 6.2 |
Median (range) | 1.0 (0–58.0) | 1.0 (0–52.0) |
ECOG PS, n (%) | ||
0 | 19 (15.2) | 28 (11.2) |
1 | 96 (76.8) | 194 (77.6) |
2 | 10 (8.0) | 28 (11.2) |
Reason for chemotherapy, n (%) | ||
Adjuvant therapy | 21 (16.8) | 35 (14.0) |
Treatment for metastatic disease | 104 (83.2) | 215 (86.0) |
Lung cancer surgery | ||
No | 98 (78.4) | 215 (86.0) |
Yes | 27 (21.6) | 35 (14.0) |