Table 1.
Study characteristics.a
| Study | Tumor type | Definition of fever (for FN) | Frequency of neutrophil counts |
|---|---|---|---|
| LIP vs. PEG | |||
| Buchner et al.35 | Breast | >38.5℃ for 1 h | Cycle 1: 24 h before chemo, daily from day 2 to 15 until ANC recovery; Cycles 2–4: daily from day 5 |
| Bondarenko et al.27 | Breast | >38.5℃ for 1 h | Cycle 1: 24 h before chemo, daily up to day 15 or until ANC recovery; Cycles 2–4: 24 h before chemo, day 1 and 3, daily from day 5 to 15 of each cycle until ANC recovery |
| LIP vs. PLA/NT | |||
| Volovat et al.33 | NSCLC | >38.5℃ for 1 h | Cycle 1: 24 h before chemo, daily up to day 15 or until ANC recovery; Cycles 2–4: 24 h before chemo, day 3, daily from day 5 to 15 of each cycle until ANC recovery, end of study visit |
| PEG vs. FIL | |||
| Green et al.25 | Breast | ≥38.2℃ | Daily |
| Grigg et al.36 | NHL | >38.2℃ | Cycle 1: day 1 and 3, daily from day 7 to 14 until ANC recovery, then 3 times per week to end of cycle; Cycles 2, 4, 5: day 3, 2 times per week to end of cycle; Cycles 3 and 6: day 3, 3 times per week to end of cycle |
| Holmes et al.37 | Breast | ≥38.2℃ | Screening, before each cycle and 1 time per week in cycle 1 |
| Holmes et al.24 | Breast | ≥38.2℃ | Screening, before each cycle and 1 time per week in cycle 1 |
| Park et al.38 | Breast | Not defined | NR |
| Shi et al.31 | Solid, NHL | >38.0℃ | Day 0, 3, 5, 7, 9, 11, 13, 17, and 21 |
| Vose et al.34 | NHL, HD | ≥38.2℃ | Day 1, daily after day 6, and at follow–up visits |
| PEG vs. PLA/NT | |||
| Balducci et al.39 | Solid, NHL | ≥38.0℃ on same day | Day 1 of each cycle; cycle 1 day 8, once between day 11 and 13, and day 15; and at nadir following cycles |
| Hecht et al.40 | Colorectal | ≥38.2℃ | NR |
| Kosaka et al.32 | Breast | ≥37.5℃ on same or following day | Cycle 1: day 1, 2, 8, 11, and 15; Remaining cycles: day 1, 2, 8, and 11; Open label: day 1 and 2 |
| Vogel et al.41 | Breast | ≥38.2℃ | NR |
| FIL vs. PLA/NT | |||
| Crawford et al.20,42 | SCLC | ≥38.2℃ | NR |
| del Giglio et al.43 | Breast | >38.5℃ for more than 1 h | 24 h from chemo and daily from day 2 to 15 or until ANC recovery |
| Doorduijn et al.44 | NHL | >38.5℃ | NR |
| Fossa et al.45 | Germ cell | >38.0℃ | Day 1 of each cycle and weekly thereafter |
| Muhonen et al.46 | Breast | NR | NR |
| Osby et al.47 | NHL | >38.5℃ once or >38.0℃ twice in 4 h | Day 8 or 9, 11 or 12, 14 or 15, and 22 |
| Pettengell et al.48 | NHL | ≥37.5℃ for 1 h | Weekly; daily if FN occurred |
| Romieu et al.49 | Breast | >38.0℃ | Day 1 and every 3 days until ANC ≥ 2 × 109/L (at least day 14 ± 2) |
| Trillet-Lenoir et al.50 | SCLC | ≥38.2℃ | 3 times per week |
| Zinzani et al.51 | NHL | NR | NR |
ANC: absolute neutrophil count; FIL: filgrastim; FN: febrile neutropenia; HD: Hodgkin’s disease; LIP: lipegfilgrastim; NHL: non-Hodgkin’s lymphoma; NR: not reported; NSCLC: non-small-cell lung cancer; NT: no treatment; PEG: pegfilgrastim; PLA: placebo; SCLC: small cell lung cancer; SN: severe neutropenia.
a
Also stipulated protocol-defined SN as the administration of systemic antibiotics (not used in meta-analysis). Grade 3 neutropenia = ANC between 0.5 × 109/L and 1.0 × 109/L; Grade 4 neutropenia = ANC < 0.5 × 109/L.