| Title | 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 |
| Authors | Xie, Jie Cao, Jun Wang, Jing-fen Zhang, Bai-hong Zeng, Xiao-hua Zheng, Hong Zhang, Yang Cai, Li Wu, Yu-dong Yao, Qiang Zhao, Xiao-chun Mao, Wei-dong Jiang, Ai-Mei Chen, Shao-shui Yang, Shun-e Wang, Shu-sen Wang, Jian-hong Pan, Yue-yin Ren, Bi-yong Chen, Yan-ju Ouyang, Li-zhi Lei, Kai-jian Gao, Jing-hua Huang, Wen-he Huang, Zhan Shou, Tao He, Yan-ling Cheng, Jing Sun, Yang Li, Wei-ming Cui, Shu-de Wang, Xin Rao, Zhi-guo Ma, Hu Liu, Wei Wu, Xue-yong Shen, Wei-xi Cao, Fei-lin Xiao, Ze-min Wu, Biao Tian, Shu-ya |
| Affiliation | Fudan Univ, Dept Med Oncol, Shanghai Canc Ctr, 270 Dongan Rd, Shanghai 200032, Peoples R China. Fudan Univ, Shanghai Med Coll, Dept Oncol, 130 Dongan Rd, Shanghai 200032, Peoples R China. Linyi Tumor Hosp, Linyi 276001, Peoples R China. Lanzhou Mil Gen Hosp Peoples Liberat Army, Lanzhou 730050, Gansu, Peoples R China. Chongqing Canc Hosp, Chongqing 400030, Peoples R China. Liaocheng Peoples Hosp, Liaocheng 252000, Peoples R China. Harbin Med Univ, Affiliated Tumor Hosp, Harbin 150081, Heilongjiang, Peoples R China. Jiangxi Canc Hosp, Nanchang 330029, Jiangxi, Peoples R China. Tianjin Peoples Hosp, Tianjin 300121, Peoples R China. Univ South China, Affiliated Hosp 1, Hengyang 421001, Peoples R China. Southeast Univ, Affiliated Jiangyin Hosp, Jiangyin 214400, Peoples R China. Kunming Med Univ, Affiliated Hosp 1, Kunming 650032, Yunnan, Peoples R China. Affiliated Hosp, Binzhou Med Sch, Binzhou 256603, Peoples R China. Xinjiang Med Univ, Tumour Hosp, Urumqi 830000, Peoples R China. Sun Yat Sen Univ, Ctr Canc, Guangzhou 510060, Guangdong, Peoples R China. Nantong Tumor Hosp, Nantong 226361, Peoples R China. Anhui Med Univ, Affiliated Hosp 1, Hefei 230022, Anhui, Peoples R China. Chongqing Three Gorges Cent Hosp, Chongqing 404000, Peoples R China. Hainan Gen Hosp, Haikou 570311, Hainan, Peoples R China. Hunan Canc Hosp, Changsha 410006, Hunan, Peoples R China. Second Peoples Hosp Yibin, Yibin 644000, Peoples R China. Cangzhou Cent Hosp, Cangzhou 061001, Peoples R China. Shantou Univ, Coll Med, Canc Hosp, Shantou 515000, Peoples R China. Yue Bei Peoples Hosp, Shaoguan 512025, Peoples R China. First Peoples Hosp Yunnan Prov, Kunming 650032, Yunnan, Peoples R China. Peking Univ, Shenzhen Hosp, Shenzhen 518036, Peoples R China. Huazhong Univ Sci & Technol, Wuhan Union Hosp, Wuhan 430022, Hubei, Peoples R China. Peoples Hosp Sanya, Sanya 572000, Peoples R China. Guangzhou Med Univ, Affiliated Hosp 3, Guangzhou 510150, Guangdong, Peoples R China. Henan Canc Hosp, Zhengzhou 450008, Henan, Peoples R China. Xiamen Univ, Zhongshan Hosp, Xiamen 361004, Peoples R China. Wuhan Gen Hosp Guangzhou Mil, Wuhan 430070, Hubei, Peoples R China. Zunyi Med Coll, Affiliated Hosp, Zunyi 563000, Peoples R China. Beihua Univ, Affiliated Hosp, Jilin 132011, Jilin, Peoples R China. Jingan Dist Ctr Hosp Shanghai, Shanghai 200040, Peoples R China. Shenzhen Peoples Hosp, Shenzhen 518020, Peoples R China. Taizhou Hosp Zhejiang Prov, Taizhou 317000, Peoples R China. First Peoples Hosp Changde City, Changde 415003, Peoples R China. Nanchang Univ, Affiliated Hosp 1, Nanchang 330006, Jiangxi, Peoples R China. Ctr Hosp Siping City, Siping 136000, Peoples R China. Wu Xi 4 Peoples Hosp, Wuxi 214000, Peoples R China. Zhejiang Univ, Affiliated Hosp 1, Hangzhou 310003, Zhejiang, Peoples R China. Fudan Univ, Dept Med Oncol, Shanghai Canc Ctr, 270 Dongan Rd, Shanghai 200032, Peoples R China. Hu, XC (reprint author), Fudan Univ, Shanghai Med Coll, Dept Oncol, 130 Dongan Rd, Shanghai 200032, Peoples R China. |
| Keywords | Breast cancer Multicenter study PEG-rhG-CSF Neutropenia COLONY-STIMULATING FACTOR SINGLE-ADMINISTRATION PEGFILGRASTIM INDUCED FEBRILE NEUTROPENIA DAILY FILGRASTIM GROWTH-FACTORS GUIDELINES UPDATE RISK |
| Issue Date | 2018 |
| Publisher | BREAST CANCER RESEARCH AND TREATMENT |
| Citation | BREAST CANCER RESEARCH AND TREATMENT. 2018, 168(2), 389-399. |
| Abstract | 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 A mu g/kg, PEG-rhG-CSF 6 mg, or rhG-CSF 5 A mu g/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 A mu g/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 A mu g/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. |
| URI | http://hdl.handle.net/20.500.11897/502752 |
| ISSN | 0167-6806 |
| DOI | 10.1007/s10549-017-4609-6 |
| Indexed | SCI(E) PubMed |
| Appears in Collections: | 深圳医院 |
