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

Autor: Shune Yang, Fei-lin Cao, Yang Zhang, Yang Sun, Xue-yong Wu, Zhonghua Wang, Jinghua Gao, Bi-yong Ren, Zhan Huang, Jian Zhang, Leiping Wang, Jie Xie, Hu Ma, Jing Cheng, Wei Liu, Y. Pan, Ai-Mei Jiang, Li Cai, Zhi-guo Rao, Yu-dong Wu, Yan-ju Chen, Yan-ling He, Wei-xi Shen, Peng Shen, Tao Shou, Dong Meng, Xin Wang, Jian-hong Wang, Wei-ming Li, Shu-yan Tian, Xichun Hu, Xiao-chun Zhao, Kai-jian Lei, Ze-min Xiao, Shude Cui, Wei-dong Mao, Bai-hong Zhang, Biyun Wang, Li-zhi Ouyang, Wen-he Huang, Shao-shui Chen, Shusen Wang, Xiao-hua Zeng, Hong Zheng, Qiang Yao, Jing-fen Wang, Jun Cao, Biao Wu
Rok vydání: 2017
Předmět:
0301 basic medicine
Adult
Male
Cancer Research
medicine.medical_specialty
China
medicine.medical_treatment
Phases of clinical research
Breast Neoplasms
Kaplan-Meier Estimate
Neutropenia
Gastroenterology
Drug Administration Schedule
Breast Neoplasms
Male
Polyethylene Glycols
03 medical and health sciences
Young Adult
0302 clinical medicine
Breast cancer
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
Granulocyte Colony-Stimulating Factor
Medicine
Humans
Prospective Studies
Chemotherapy-Induced Febrile Neutropenia
Adverse effect
Aged
Myelosuppressive Chemotherapy
Chemotherapy
business.industry
Incidence (epidemiology)
Incidence
fungi
Middle Aged
medicine.disease
Progression-Free Survival
Recombinant Proteins
030104 developmental biology
Oncology
030220 oncology & carcinogenesis
Female
business
Febrile neutropenia
Zdroj: Breast cancer research and treatment. 168(2)
ISSN: 1573-7217
Popis: 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. 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. 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). 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.
Databáze: OpenAIRE
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