Advantages with prophylactic PEG-rhG-CSF versus rhG-CSF in breast cancer patients receiving multiple cycles of myelosuppressive chemotherapy: an open-label, randomized, multicenter ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2018-04

AUTHORS

Jie Xie, Jun Cao, Jing-fen Wang, Bai-hong Zhang, Xiao-hua Zeng, Hong Zheng, Yang Zhang, Li Cai, Yu-dong Wu, Qiang Yao, Xiao-chun Zhao, Wei-dong Mao, Ai-Mei Jiang, Shao-shui Chen, Shun-e Yang, Shu-sen Wang, Jian-hong Wang, Yue-yin Pan, Bi-yong Ren, Yan-ju Chen, Li-zhi Ouyang, Kai-jian Lei, Jing-hua Gao, Wen-he Huang, Zhan Huang, Tao Shou, Yan-ling He, Jing Cheng, Yang Sun, Wei-ming Li, Shu-de Cui, Xin Wang, Zhi-guo Rao, Hu Ma, Wei Liu, Xue-yong Wu, Wei-xi Shen, Fei-lin Cao, Ze-min Xiao, Biao Wu, Shu-yan Tian, Dong Meng, Peng Shen, Bi-yun Wang, Zhonghua Wang, Jian Zhang, Leiping Wang, Xi-chun Hu

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. More... »

PAGES

389-399

Journal

TITLE

Breast Cancer Research and Treatment

ISSUE

2

VOLUME

168

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s10549-017-4609-6

DOI

http://dx.doi.org/10.1007/s10549-017-4609-6

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1099697577

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29230663


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