1. Advantages with prophylactic PEG-rhG-CSF versus rhG-CSF in breast cancer patients receiving multiple cycles of myelosuppressive chemotherapy: an open-label, randomized, multicenter phase III study.
- Author
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Xie J, Cao J, Wang JF, Zhang BH, Zeng XH, Zheng H, Zhang Y, Cai L, Wu YD, Yao Q, Zhao XC, Mao WD, Jiang AM, Chen SS, Yang SE, Wang SS, Wang JH, Pan YY, Ren BY, Chen YJ, Ouyang LZ, Lei KJ, Gao JH, Huang WH, Huang Z, Shou T, He YL, Cheng J, Sun Y, Li WM, Cui SD, Wang X, Rao ZG, Ma H, Liu W, Wu XY, Shen WX, Cao FL, Xiao ZM, Wu B, Tian SY, Meng D, Shen P, Wang BY, Wang Z, Zhang J, Wang L, and Hu XC
- Subjects
- Adult, Aged, Breast Neoplasms mortality, Breast Neoplasms pathology, Breast Neoplasms, Male mortality, Breast Neoplasms, Male pathology, Chemotherapy-Induced Febrile Neutropenia etiology, Chemotherapy-Induced Febrile Neutropenia prevention & control, China epidemiology, Drug Administration Schedule, Female, Granulocyte Colony-Stimulating Factor administration & dosage, Humans, Incidence, Kaplan-Meier Estimate, Male, Middle Aged, Polyethylene Glycols administration & dosage, Progression-Free Survival, Prospective Studies, Recombinant Proteins administration & dosage, Recombinant Proteins therapeutic use, Young Adult, Antineoplastic Combined Chemotherapy Protocols adverse effects, Breast Neoplasms drug therapy, Breast Neoplasms, Male drug therapy, Chemotherapy-Induced Febrile Neutropenia epidemiology, Granulocyte Colony-Stimulating Factor therapeutic use, Polyethylene Glycols therapeutic use
- Abstract
Background: PEG-rhG-CSF reduces neutropenia and improves chemotherapy safety. In China's registration trial (CFDA: 2006L01305), we assessed its efficacy and safety against rhG-CSF, and prospectively explored its value over multiple cycles of chemotherapy., Methods: In this open-label, randomized, multicenter phase 3 study, breast cancer patients (n = 569) were randomized to receive PEG-rhG-CSF 100 µg/kg, PEG-rhG-CSF 6 mg, or rhG-CSF 5 µg/kg/d after chemotherapy. The primary endpoints were the incidence and duration of grade 3/4 neutropenia during cycle 1. Secondary endpoints included the incidence and duration of grade 3/4 neutropenia during cycles 2-4, the incidence of febrile neutropenia, and the safety., Results: A once-per-cycle PEG-rhG-CSF at either 100 µg/kg or 6 mg was not different from daily injections of rhG-CSF for either incidence or duration of grade 3/4 neutropenia. Interestingly, a substantial difference was noted during cycle 2, and the difference became bigger over cycles 3-4, reaching a statistical significance at cycle 4 in either incidence (P = 0.0309) or duration (P = 0.0289) favoring PEG-rhG-CSF. A significant trend toward a lower incidence of all-grade adverse events was noted at 129 (68.98%), 142 (75.53%), and 160 (82.47%) in the PEG-rhG-CSF 100 µg/kg and 6 mg and rhG-CSF groups, respectively (P = 0.0085). The corresponding incidence of grade 3/4 drug-related adverse events was 2/187 (1.07%), 1/188 (0.53%), and 8/194 (4.12%), respectively (P = 0.0477). Additionally, PFS in metastatic patients preferred PEG-rhG-CSF to rhG-CSF despite no significance observed by Kaplan-Meier analysis (n = 49, P = 0.153)., Conclusions: PEG-rhG-CSF is a more convenient and safe formulation and a more effective prophylactic measure in breast cancer patients receiving multiple cycles of chemotherapy.
- Published
- 2018
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