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
机构：[1]Department of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong’an Road, Shanghai 200032, China[2]Department of Oncology, Shanghai Medical College, Fudan University, 130 Dong’an Road, Shanghai 200032, China[3]Linyi Tumor Hospital, Linyi 276001, China[4]Lanzhou Military General Hospital of People’s Liberation Army, Gansu Lanzhou 730050, China[5]Chongqing Cancer Hospital, Chongqing 400030, China[6]Liaocheng People’s Hospital, Liaocheng 252000, China[7]The Affiliated Tumor Hospital of Harbin Medical University, Harbin 150081, China[8]Jiangxi Cancer Hospital, Nanchang 330029, China[9]Tianjin People’s Hospital, Tianjin 300121, China[10]The First Affiliated Hospital Of University Of South China, Hengyang 421001, China[11]The Affiliated Jiangyin Hospital of Southeast University Medical College, Jiangyin 214400, China[12]First Affiliated Hospital of Kunming Medical University, Kunming 650032, China昆明医科大学附属第一医院[13]Binzhou Medical School Affiliated Hospital, Binzhou 256603, China[14]Tumour Hospital Affiliated To Xinjiang Medical University, Urumqi 830000, China[15]Sun Yat-sen University Cancer Center, Guangzhou 510060, China[16]Nantong Tumor Hospital, Nantong 226361, China[17]The First Affiliated Hospital Of Anhui Medical University, Hefei 230022, China[18]Chongqing Three Gorges Central Hospital, Chongqing 404000, China[19]Hainan General Hospital, Haikou 570311, China[20]Hunan Cancer Hospital, Changsha 410006, China[21]The Second People’s Hospital of Yibin, Yibin 644000, China[22]Cangzhou Central Hospital, Cangzhou 061001, China[23]Cancer Hospital of Shantou University Medical College, Shantou 515000, China[24]Yue Bei People’s Hospital, Shaoguan 512025, China[25]The First People’s Hospital of Yunnan Province, Kunming 650032, China云南省第一人民医院[26]Peking University Shenzhen Hospital, Shenzhen 518036, China北京大学深圳医院深圳医学信息中心[27]Huazhong University of Science and Technology Wuhan Union Hospital, Wuhan 430022, China华中科技大学同济医学院附属协和医院[28]People’s Hospital of Sanya, Sanya 572000, China[29]The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou 510150, China[30]Henan Cancer Hospital, Zhengzhou 450008, China河南省肿瘤医院[31]Zhongshan Hospital Affiliated To Xiamen University, Xiamen 361004, China[32]Wuhan General Hospital of Guangzhou Military, Wuhan 430070, China[33]Affiliated Hospital of Zunyi Medical College, Zunyi 563000, China[34]Affiliated Hospital of Beihua University, Jilin 132011, China[35]Jing’an District Centre Hospital of Shanghai, Shanghai 200040, China[36]Shenzhen People’s Hospital, Shenzhen 518020, China深圳市人民医院深圳医学信息中心[37]Taizhou Hospital of Zhejiang Province, Taizhou 317000, China台州恩泽医疗中心(集团)台州医院[38]The First People’s Hospital of Changde City, Changde 415003, China[39]The First Affiliated Hospital of Nanchang University, Nanchang 330006, China[40]The Centre Hospital of Siping City, Siping 136000, China[41]Wu Xi No.4 People’s Hospital, Wuxi 214000, China[42]The First Affiliated Hospital Of Zhejiang University, Hangzhou 310003, China浙江大学医学院附属第一医院
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.
基金：
This study was funded by Shangdong New
Time Pharmaceutical Co., LTD. PEG-rhG-CSF was provided by the
funding source.
第一作者机构：[1]Department of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong’an Road, Shanghai 200032, China[2]Department of Oncology, Shanghai Medical College, Fudan University, 130 Dong’an Road, Shanghai 200032, China
共同第一作者：
通讯作者：
通讯机构：[1]Department of Medical Oncology, Fudan University Shanghai Cancer Center, 270 Dong’an Road, Shanghai 200032, China[2]Department of Oncology, Shanghai Medical College, Fudan University, 130 Dong’an Road, Shanghai 200032, China
推荐引用方式(GB/T 7714)：
Jie Xie,Jun Cao,Jing‑fen Wang,et al.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[J].BREAST CANCER RESEARCH AND TREATMENT.2018,168(2):389-399.doi:10.1007/s10549-017-4609-6.
APA：
Jie Xie,Jun Cao,Jing‑fen Wang,Bai‑hong Zhang,Xiao‑hua Zeng...&Xi‑chun Hu.(2018).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.BREAST CANCER RESEARCH AND TREATMENT,168,(2)
MLA：
Jie Xie,et al."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".BREAST CANCER RESEARCH AND TREATMENT 168..2(2018):389-399
