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- W2999398743 abstract "ABSTRACT Background Cancer chemotherapy frequently causes neutropenia, leading to an increased risk of infections and delays in subsequent chemotherapy treatments. In a randomized, double-blind, phase 3, active-controlled, noninferiority trial, the efficacy and safety of lipegfilgrastim, a glycosylated and pegylated recombinant granulocyte colony stimulating factor (G-CSF), was compared with pegfilgrastim, a pegylated recombinant G-CSF. Here we report the results of the absolute neutrophil counts (ANC) from this study. Methods Patients with high-risk stage II, III, or IV breast cancer and an absolute neutrophil count ≥1.5x109 cells/L were randomly assigned to lipegfilgrastim 6 mg (n = 101) or pegfilgrastim 6 mg (n = 101). Study medication was injected subcutaneously on day 2 of the chemotherapy cycle (4 cycles maximum). The primary efficacy endpoint, the duration of severe neutropenia, was reported previously. Secondary endpoints included ANC nadir and time to ANC recovery and were analyzed using a Poisson regression. The intent-to-treat (ITT) analysis population included all randomized patients. Results ANC nadir and time to ANC recovery for cycle 1 (ITT population) are summarized in the table. Measurement Lipegfilgrastim (n = 101) Pegfilgrastim (n = 101) LS Mean Difference (95% CI), p value Depth of ANC nadir (109/L) Mean (SD) 1.2 (1.3) 1.0 (1.2) 0.146 (-0.169 to 0.461) Median (range) 0.6 (0.0 to 5.5) 0.4 (0.0 to 5.2) p = 0.3610 Time to ANC recovery (days) Mean (SD) 5.8 (3.3) 7.4 (3.6) -1.570 (-2.547 to -0.592) Median (range) 7.0 (0.0 to 12.0) 8.0 (0.0 to 21.0) p = 0.0018 Conclusions Patients who received lipegfilgrastim had significantly faster time to ANC recovery than those who received pegfilgrastim. Disclosure O.A. Gladkov: Investigator in Teva-sponsored studies, I.M. Bondarenko: Investigator in Teva-sponsored studies R. Elsaesser: Employee of Teva Pharmaceuticals and own Teva Pharmaceuticals stock, A. Buchner: Employee of Teva Pharmaceuticals and own Teva Pharmaceuticals stock, P. Bias: Employee of Teva Pharmaceuticals and own Teva Pharmaceuticals stock." @default.
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- W2999398743 date "2012-09-01" @default.
- W2999398743 modified "2023-09-26" @default.
- W2999398743 title "Absolute Neutrophil Counts in a Study of Lipegfilgrastim Compared with Pegfilgrastim in Patients with Breast Cancer Who are Receiving Chemotherapy" @default.
- W2999398743 doi "https://doi.org/10.1016/s0923-7534(20)34120-x" @default.
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