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

• DOI: 10.21037/atm.2019.07.95
• Publication Date: 2019-09-30T05:24:50Z
• Authors: Fengrui Xu; Yang Zhang; Zhanhui Miao; Xiaohua Zeng; Biao Wu; Li Cai; Jinping Liu; Shusen Wang; Xichun Hu; Wenbo Zheng; Zhiyue Chen; Qing Yang; Zefei Jiang
• Keywords: Clinical endpoint

Neutropenia is a common complication from chemotherapy. Mecapegfilgramtim (code name HHPG-19K), 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.This randomized, controlled non-inferiority study. A total 339 breast cancer patients who were eligible (neo) adjuvant chemotherapy randomized assigned into three groups receive 100 µg/kg, fixed dose 6 mg or filgrastim 5 µg/kg/day in first cycle The primary endpoint duration grade ≥3 1. secondary endpoints included cycles 2-4, incidence neutropenia, febrile (FN). profile also evaluated.The mean 1.06 [95% confidence interval (CI): 0.65, 1.26] days µg/kg group, 1.23 (95% CI: 0.84, 1.88) 2.06 1.66, 2.46) group. difference between -1.00 -1.52, -0.48), -0.83 -1.36, -0.30). upper bounds 95% CI all <1 day (the predefined margin). For 4 showed better performance filgrastim. FN, there no treated profile, two doses well-tolerated. Fixed exhibited comparable comparison during cycles.Long-acting (100 mg) very effective well tolerated when administered prophylaxis induced consecutive-cycle treatment. In some clinical parameters, mecafilgrastim non-inferior even superior mg-dose regimen similar regimen, would be preference practice, due convenient once-per-cycle administration high-degree treatment compliance patients. provided new evidence novel rhG-CSF, mecapegfilgrastim, which alternative practice neutropenia.