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Efficacy and safety of mecapegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer: a randomized, multicenter, active-controlled phase III trial

  
@article{ATM28505,
	author = {Fengrui Xu and Yang Zhang and Zhanhui Miao and Xiaohua Zeng and Biao Wu and Li Cai and Jinping Liu and Shusen Wang and Xichun Hu and Wenbo Zheng and Zhiyue Chen and Qing Yang and Zefei Jiang},
	title = {Efficacy and safety of mecapegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer: a randomized, multicenter, active-controlled phase III trial},
	journal = {Annals of Translational Medicine},
	volume = {7},
	number = {18},
	year = {2019},
	keywords = {},
	abstract = {Background: Neutropenia is a common complication from chemotherapy. Mecapegfilgramtim (code name HHPG-19K), a long-acting recombinant human granulocyte colony-stimulating factor (rhG-CSF), has been developed. This study was to evaluate the efficacy and safety of mecapegfilgrastim for reducing neutropenia compared with filgrastim.
Methods: This was a randomized, controlled non-inferiority study. A total of 339 breast cancer patients who were eligible for (neo) adjuvant chemotherapy were randomized assigned into three groups to receive mecapegfilgrastim 100 μg/kg, mecapegfilgrastim fixed dose of 6 mg or filgrastim 5 μg/kg/day in the first cycle of chemotherapy. The primary endpoint was the duration of grade ≥3 neutropenia in cycle 1. The secondary endpoints included the duration of grade ≥3 neutropenia in cycles 2–4, incidence of grade ≥3 neutropenia, and febrile neutropenia (FN). The safety profile was also evaluated. 
Results: The mean duration of grade ≥3 neutropenia was 1.06 [95% confidence interval (CI): 0.65, 1.26] days in mecapegfilgrastim 100 μg/kg group, 1.23 (95% CI: 0.84, 1.88) days in mecapegfilgrastim 6 mg group, and 2.06 (95% CI: 1.66, 2.46) days in the filgrastim group. The mean difference between mecapegfilgrastim 100 μg/kg and filgrastim was –1.00 (95% CI: –1.52, –0.48), the mean difference between mecapegfilgrastim 6 mg and filgrastim was –0.83 (95% CI: –1.36, –0.30). The upper bounds of 95% CI for the difference between mecapegfilgrastim and filgrastim were all },
	issn = {2305-5847},	url = {http://atm.amegroups.com/article/view/28505}
}