title: [A multicenter, randomized, controlled, phase Ⅲ clinical study of PEG-rhG-CSF for preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer].
abstract: OBJECTIVE
  To explore the safety and efficacy of pegylated recombinant human granulocyte colony-stimulating factor (PEG-rhG-CSF) in preventing chemotherapy-induced neutropenia in patients with breast cancer and non-small cell lung cancer (NSCLC), and to provide the basis for clinical application.
  
  
  METHODS
  According to the principle of open-label, randomized, parallel-group controlled clinical trial, all patients were randomized by 1∶1∶1 into three groups to receive PEG-rhG-CSF 100 μg/kg, PEG-rhG-CSF 6 mg, or rhG-CSF 5 μg/kg, respectively. The patients with breast cancer received two chemotherapy cycles, and the NSCLC patients received 1-2 cycles of chemotherapy according to their condition. All patients were treated with the combination chemotherapy of TAC (docetaxel+ epirubicin+ cyclophosphamide) or TA (docetaxel+ epirubicin), or the chemotherapy of docetaxel combined with carboplatin, with a 21 day cycle.
  
  
  RESULTS
  The duration of grade 3-4 neutropenia in the PEG-rhG-CSF 100 μg/kg and PEG-rhG-CSF 6 mg groups were similar with that in the rhG-CSF 5 μg/kg group (P>0.05 for all). The incidence rate of grade 3-4 neutropenia in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group, and G-CSF 5 μg/kg group were 69.7%, 68.4%, and 69.5%, respectively, with a non-significant difference among the three groups (P=0.963). The incidence rate of febrile neutropenia in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 μg/kg group were 6.1%, 6.4%, and 5.5%, respectively, showing no significant difference among them (P=0.935). The incidence rate of adverse events in the PEG-rhG-CSF 100 μg/kg group, PEG-rhG-CSF 6 mg group and G-CSF 5 μg / kg group were 6.7%, 4.1%, and 5.5%, respectively, showing a non-significant difference among them (P=0.581).
  
  
  CONCLUSIONS
  In patients with breast cancer and non-small cell lung cancer (NSCLC) undergoing TAC/TA chemotherapy, a single 100 μg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF at 48 hours after chemotherapy show definite therapeutic effect with a low incidence of adverse events and mild adverse reactions. Compared with the continuous daily injection of rhG-CSF 5 μg/kg/d, a single 100 μg/kg injection or a single fixed 6 mg dose of PEG-rhG-CSF has similar effect and is more advantageous in preventing chemotherapy-induced neutropenia.
authors.affiliation: Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing 100021, China.
authors.forename: Binghe
authors.initials: B
authors.lastname: Xu
authors.affiliation: Department of Breast Surgery, Shanxi Province Cancer Center, Taiyuan 030013, China.
authors.forename: Fuguo
authors.initials: F
authors.lastname: Tian
authors.affiliation: Department of Oncology, Sichuan Provincial Tumor Hospital, Chengdu 610041, China.
authors.forename: Jingrui
authors.initials: J
authors.lastname: Yu
authors.affiliation: Cancer Center, the First Hospital of Jilin University, Changchun 130021, China.
authors.forename: Yanqiu
authors.initials: Y
authors.lastname: Song
authors.affiliation: Department of Oncology, Cancer Hospital of Linyi City, Linyi 276001, China.
authors.forename: Jianhua
authors.initials: J
authors.lastname: Shi
authors.affiliation: Department of Oncology, Lanzhou General Hospital, Lanzhou Command, Lanzhou 730050, China.
authors.forename: Baihong
authors.initials: B
authors.lastname: Zhang
authors.affiliation: Department of Oncology, Shanxi Provincial Tumor Hospital Xi'an 710061, China.
authors.forename: Yanjun
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Oncology, the Second People's Hospital of Yibin City, Yibin 644000, China.
authors.forename: Zhiping
authors.initials: Z
authors.lastname: Yuan
authors.affiliation: Department of Oncology, Cancer Hospital of Bengbu Medical College, Bengbu 233004, China.
authors.forename: Qiong
authors.initials: Q
authors.lastname: Wu
authors.affiliation: Department of Oncology, Cancer Hospital of Harbin Medical University, Harbin 150081, China.
authors.forename: Qingyuan
authors.initials: Q
authors.lastname: Zhang
authors.affiliation: Department of Oncology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.
authors.forename: Kejun
authors.initials: K
authors.lastname: Nan
authors.affiliation: Department of Breast Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Sun
authors.affiliation: Department of Oncology, the People's Hospital of Tianjin City, Tianjin 300121, China.
authors.forename: Weilian
authors.initials: W
authors.lastname: Li
authors.affiliation: Department of Oncology, the First People's Hospital of Yueyang City, Yueyang 414000, China.
authors.forename: Jianbing
authors.initials: J
authors.lastname: Hu
authors.affiliation: Cancer Therapy & Research Center, Jinan Military Command General Hospital, Jinan 250012, China.
authors.forename: Jingwang
authors.initials: J
authors.lastname: Bi
authors.affiliation: Department of Oncology, Central Hospital of Siping City, Siping 136000, China.
authors.forename: Chun
authors.initials: C
authors.lastname: Meng
authors.affiliation: Department of Oncology, Beijing Chaoyang Hospital of Capital Medical University, Beijing 100020, China.
authors.forename: Hong
authors.initials: H
authors.lastname: Dai
authors.affiliation: Department of General Surgery, Beijing Chaoyang Hospital of Capital Medical University, Beijing 100020, China.
authors.forename: Hongchuan
authors.initials: H
authors.lastname: Jiang
authors.affiliation: Department of Oncology, the First Hospital of Huai'an City, Nanjing Medical University, Nanjing 223300, China.
authors.forename: Shun
authors.initials: S
authors.lastname: Yue
authors.affiliation: Department of Oncology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.
authors.forename: Bangwei
authors.initials: B
authors.lastname: Cao
authors.affiliation: Department of Oncology, Jinan City Central Hospital, Jinan 250015, China.
authors.forename: Yuping
authors.initials: Y
authors.lastname: Sun
authors.affiliation: Department of Breast Surgery, Peking University People's Hospital, Beijing 100044, China.
authors.forename: Shu
authors.initials: S
authors.lastname: Wang
authors.affiliation: Department of Breast Cancer, Cancer Hospital of Tianjin City, Tianjin 300060, China.
authors.forename: Zhongsheng
authors.initials: Z
authors.lastname: Tong
authors.affiliation: Department of Chemotherapy, the First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.
authors.forename: Peng
authors.initials: P
authors.lastname: Shen
authors.affiliation: Cancer Center, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.
authors.forename: Gang
authors.initials: G
authors.lastname: Wu
authors.affiliation: Department of Breast Cancer, Xiangya Hospital, Central South University, Changsha 410008, China.
authors.forename: Lili
authors.initials: L
authors.lastname: Tang
authors.affiliation: Department of Oncological Surgery, the Second Affiliated Hospital, Zhejiang University, Hangzhou 310009, China.
authors.forename: Yongchuan
authors.initials: Y
authors.lastname: Deng
authors.affiliation: Department of Oncology, China-Japan Friendship Hospital, Beijing 100029, China.
authors.forename: Liqun
authors.initials: L
authors.lastname: Jia
authors.affiliation: Department of Breast Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China.
authors.forename: Kunwei
authors.initials: K
authors.lastname: Shen
authors.affiliation: Department of Thoracic Oncology, Fujian Provincial Cancer Hospital, Fuzhou 350014, China.
authors.forename: Wu
authors.initials: W
authors.lastname: Zhuang
authors.affiliation: Department of Oncology, the General Hospital of PLA Shenyang Military Command, Shenyang 110015, China.
authors.forename: Xiaodong
authors.initials: X
authors.lastname: Xie
authors.affiliation: Department of Oncology, the First Affiliated Hospital of Nanhua University, Hengyang 421001, China.
authors.forename: Youhua
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Department of Oncology, People's Hospital of Sichuan Province, Chengdu 610000, China.
authors.forename: Lin
authors.initials: L
authors.lastname: Chen
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols; D001943:Breast Neoplasms / Q000188:drug therapy*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D060828:Induction Chemotherapy; D008175:Lung Neoplasms / Q000188:drug therapy*; D009503:Neutropenia / Q000139:chemically induced / Q000453:epidemiology / Q000517:prevention & control*; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D043823:Taxoids; C486981:pegylated granulocyte colony-stimulating factor, human; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D011092:Polyethylene Glycols; D015251:Epirubicin; D003520:Cyclophosphamide; D016190:Carboplatin