Table 1 Demographic and breast cancer history data—FAS (As Randomized)
Proposed biosimilar pegfilgrastim (APO-Peg) (N = 294) | US-licensed pegfilgrastim reference product (US-Neulasta®) (N = 148) | EU-approved pegfilgrastim reference product (EU-Neulasta®) (N = 147) | Total (N = 589) | |
|---|---|---|---|---|
Demographic data | ||||
Female, n (%) | 294 (100) | 148 (100) | 147 (100) | 589 (100) |
Age (years) | ||||
Mean (SD) | 51.9 (10.0) | 51.4 (10.4) | 51.5 (10.2) | 51.7 (10.1) |
Median (min, max) | 52.0 (24.0, 75.0) | 52.0 (27.0, 80.0) | 53.0 (22.0, 77.0) | 52.0 (22.0, 80.0) |
Race, n (%) Caucasian | 294 (100.0) | 148 (100.0) | 147 (100.0) | 589 (100.0) |
Body weight (kg) | ||||
Mean (SD) | 73.88 (14.4) | 72.01 (14.1) | 72.61 (12.9) | 73.09 (14.0) |
Median (min, max) | 73.0 (40.0, 120.0) | 70.0 (40.0, 118.0) | 70.0 (48.0, 119.0) | 72.0 (40.0, 120.0) |
Body height (cm) | ||||
Mean (SD) | 162.5 (6.8) | 162.7 (6.6) | 162.6 (6.4) | 162.6 (6.6) |
Median (min, max) | 163.0 (140.0, 180.0) | 163.0 (142.0, 180.0) | 163.0 (148.0, 183.0) | 163.0 (140.0, 183.0) |
Breast cancer history | ||||
Tumor parameter | ||||
Staging IIA | 129 (43.9) | 59 (39.9) | 58 (39.5) | 246 (41.8) |
Staging IIB | 79 (26.9) | 40 (27.0) | 44 (29.9) | 163 (27.7) |
Staging IIIA | 86 (29.3) | 49 (33.1) | 45 (30.6) | 180 (30.6) |