Table 3.
ANC trajectory in patients who received pegfilgrastim on the same day as chemotherapy versus the next day in cycle 1 and cycle 3
| ANC trajectory metrics | Same day | Next day | p valuea |
|---|---|---|---|
| Cycle 1 | |||
| Baseline ANC (109/L) | |||
| Mean ± SD (n b) | 8.99 ± 5.78 (94) | 9.64 ± 5.98 (96) | |
| Median (Q1, Q3) | 7.14 (4.42, 12.18) | 8.08 (5.31, 13.39) | 0.404 |
| ANC at nadir (109/L) | |||
| Mean ± SD (n b) | 1.33 ± 2.32 (95) | 1.83 ± 2.96 (96) | |
| Median (Q1, Q3) | 0.13 (0.04, 1.31) | 0.54 (0.11, 2.04) | 0.003 |
| Time to ANC nadir (days) | |||
| Mean ± SD (n b) | 7.52 ± 2.48 (95) | 7.61 ± 1.43 (96) | |
| Median (Q1, Q3) | 7.00 (7.00, 8.00) | 7.00 (7.00, 8.00) | 0.019 |
| Time to ANC nadir distribution, n (%) | |||
| <7 days | 21 (22.1) | 7 (7.3) | 0.028 |
| 7 days | 40 (42.1) | 43 (44.8) | |
| 8 days | 23 (24.2) | 30 (31.3) | |
| >8 days | 11 (11.6) | 16 (16.7) | |
| Cycle 3 | |||
| Baseline ANC (109/L) | |||
| Mean ± SD (n b) | 8.65 ± 4.74 (30) | 9.32 ± 5.33 (33) | |
| Median (Q1, Q3) | 8.67 (4.92, 12.14) | 7.99 (4.34, 13.90) | 0.549 |
| ANC at nadir (109/L) | |||
| Mean ± SD (n b) | 0.27 ± 0.50 (30) | 0.74 ± 0.93 (33) | |
| Median (Q1, Q3) | 0.07 (0.04, 0.27) | 0.37 (0.14, 1.00) | <0.001 |
| Time to ANC nadir (days) | |||
| Mean ± SD (n b) | 7.53 ± 0.73 (30) | 7.70 ± 0.88 (33) | |
| Median (Q1, Q3) | 7.00 (7.00, 8.00) | 7.00 (7.00, 8.00) | 0.503 |
| Time to ANC nadir distributionc n (%) | |||
| ≤7 days | 18 (60.0) | 17 (51.5) | 0.829 |
| 8 days | 8 (26.7) | 11 (33.3) | |
| >8 days | 4 (13.3) | 5 (15.2) | |
Analyses in cycle 1 include data from eligible patients in Amgen studies 20020134, 20020778, 20030122, and 20030123 and in cycle 3 include data from eligible patients in Amgen studies 20020778 and 20030122
Bold indicates p < 0.05
ANC absolute neutrophil count; Q1 quartile 1; Q3 quartile 3; SD standard deviation
aWilcoxon rank sum test was used to test differences of baseline ANC, ANC at nadir, and time to nadir (continuous), and Chi-square test or Fisher’s exact test (if expected cell frequency was <5) was used to test difference of time to nadir distribution (<7 days, 7 days, 8 days, and >8 days) between same-day versus next-day patients
bThe n for each parameter (of each treatment arm) is the number of patients eligible for the corresponding statistics in cycle 1 or cycle 3
cNo patients reached ANC nadir in <7 days in cycle 3, so <7 days and 7 days were combined