Table 2.
Efbemalenograstim alfa | Pegfilgrastim 6 mg N = 30 |
||
---|---|---|---|
240 µg/kg N = 30 |
320 µg/kg N = 29 |
||
Moderate and severe neutropenia (ANC < 1.0 × 109/L) | |||
Duration, days | |||
Mean (SD) | 2.1 (1.58) | 2.1 (1.46) | 1.8 (1.28) |
Median (range) | 2.0 (0, 6) | 2.0 (0, 4) | 2.0 (0, 4) |
Difference vs. pegfilgrastim (95% CI) | 0.3 (−0.4, 1.1) | 0.3 (−0.4, 1.1) | |
Non-inferior to pegfilgrastim? | Yes | Yes | |
Superior to pegfilgrastim? | No | No | |
Severe neutropenia (ANC < 0.5 × 109/L) | |||
Duration, days | |||
Mean (SD) | 1.5 (1.55) | 1.4 (1.15) | 1.1 (1.01) |
Median (range) | 1.0 (0, 6) | 2.0 (0, 4) | 1.0 (0, 3) |
Difference vs. pegfilgrastim (95% CI) | 0.4 (−0.2, 1.0) | 0.4 (−0.3, 1.0) |
ANC Absolute neutrophil count; CI Confidence interval; SD Standard deviation; TAC Taxotere® [docetaxel] + doxorubicin + cyclophosphamide