Efficacy and safety of lipegfilgrastim versus pegfilgrastim: a randomized, multicenter, active-control phase 3 trial in patients with breast cancer receiving doxorubicin/docetaxel chemotherapy

Table 4 Time to ANC recovery in cycles 1–4 (per protocol population)

	Cycle 1		Cycle 2		Cycle 3		Cycle 4
	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg	Pegfilgrastim 6 mg	Lipegfilgrastim 6 mg
Mean ± SD	7.4 ± 3.6	5.9 ± 3.4	5.3 ± 4.6	3.6 ± 4.1	5.1 ± 4.3	3.9 ± 4.8	4.3 ± 4.7	3.3 ± 4.1
Median (range)	8 (0–21.0)	7 (0–12.0)	7 (0–18.0)	0 (0–15.0)	7 (0–13.0)	0 (0–21.0)	6 (0–21.0)	0 (0–13.0)
LS mean	−1.589		−1.661		−1.344		−0.802
(95% CI)^*	(−2.615%, –0.563%)		(−2.885%, –0.436%)		(−2.579%, −0.108%)		(−2.098%, 0.493%)
p value^†	0.0026		0.0082		0.0332		0.2234

^*Least-squares mean, 95% CI, and p value are for the Poisson regression analysis lipegfilgrastim – pegfilgrastim.
^† p value is based on null hypothesis of equality.
CI confidence interval, LS least-squares, SD standard deviation.

ISSN: 1471-2407