Table 3.
Incidence of neutropenia in chemotherapy cycle 1 and time to recovery post nadir
| Efbemalenograstim alfa | Pegfilgrastim 6 mg |
|||
|---|---|---|---|---|
| 80 µg/kg | 240 µg/kg | 320 µg/kg | ||
| TAC chemotherapy population | N = 30 | N = 29 | N = 30 | |
| ANC < 1.0 × 109/L, n/N (%) | 23/30 (76.7) | 22/29 (75.9) | 23/30 (76.7) | |
| Difference vs. pegfilgrastim (P)a | 0.0 (1.0000) | −0.8 (1.0000) | ||
| ANC < 0.5 × 109/L, n/N (%) | 20/30 (66.7) | 21/29 (72.4) | 19/30 (63.3) | |
| Difference vs. pegfilgrastim (P)a | 3.3 (1.0000) | 9.1 (0.5796) | ||
| ANC depth of nadir, mean (SD), × 109/L | 0.68 (1.064) | 0.86 (1.407) | 0.78 (1.283) | |
| Days to recovery post nadir, mean (SD)b | 2.4 (1.56) | 2.0 (1.27) | 1.9 (1.20) | |
| Difference vs. pegfilgrastim (95% CI) | 0.4 (−0.3, 1.1) | 0.0 (−0.7, 0.7) | ||
| TC chemotherapy population | N = 35 | N = 37 | N = 31 | N = 35 |
| ANC < 1.0 × 109/L, n/N (%) | 10/35 (28.6) | 10/37 (27.0) | 6/31 (19.4) | 7/35 (20.0) |
| Difference vs. pegfilgrastim (P)a | 8.6 (0.5781) | 7.0 (0.5830) | −0.6 (1.000) | |
| ANC < 0.5 × 109/L, n/N (%) | 4/35 (11.4) | 7/37 (18.9) | 5/31 (16.1) | 3/35 (8.6) |
| Difference vs. pegfilgrastim (P)a | 2.9 (1.0000) | 10.3 (0.3092) | 7.6 (0.4591) | |
| ANC depth of nadir, mean (SD), × 109/L | 2.09 (1.525) | 2.41 (1.856) | 3.00 (2.608) | 3.05 (2.309) |
| Days to recovery post nadir, mean (SD)b | 1.1 (1.28) | 0.6 (0.95) | 0.5 (0.81) | 0.4 (0.60) |
| Difference vs. pegfilgrastim (95% CI) | 0.7 (0.2, 1.1) | 0.3 (−0.2, 0.7) | 0.2 (−0.3, 0.6) | |
ANC Absolute neutrophil count; CI Confidence interval; SD Standard deviation; TAC Taxotere® [docetaxel] + doxorubicin + cyclophosphamide; TC Taxotere® [docetaxel] + cyclophosphamide
a Fisher’s Exact test
b Days to recovery post nadir was a return of ANC to > 2.0 × 109/L