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.

Binghe XU; Fuguo TIAN; Jingrui YU; Yanqiu SONG; Jianhua SHI; Baihong ZHANG; Yanjun ZHANG; Zhiping YUAN; Qiong WU; Qingyuan ZHANG; Kejun NAN; Qiang SUN; Weilian LI; Jianbing HU; Jingwang BI; Chun MENG; Hong DAI; Hongchuan JIANG; Shun YUE; Bangwei CAO; Yuping SUN; Shu WANG; Zhongsheng TONG; Peng SHEN; Gang WU; Lili TANG; Yongchuan DENG; Liqun JIA; Kunwei SHEN; Wu ZHUANG; Xiaodong XIE; Youhua WU; Lin CHEN

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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.

VernacularTitle:聚乙二醇化重组人粒细胞刺激因子预防化疗后中性粒细胞减少的多中心随机对照Ⅲ期临床研究
Author: Binghe XU ¹ ; Fuguo TIAN ² ; Jingrui YU ³ ; Yanqiu SONG ⁴ ; Jianhua SHI ⁵ ; Baihong ZHANG ⁶ ; Yanjun ZHANG ⁷ ; Zhiping YUAN ⁸ ; Qiong WU ⁹ ; Qingyuan ZHANG ¹⁰ ; Kejun NAN ¹¹ ; Qiang SUN ¹² ; Weilian LI ¹³ ; Jianbing HU ¹⁴ ; Jingwang BI ¹⁵ ; Chun MENG ¹⁶ ; Hong DAI ¹⁷ ; Hongchuan JIANG ¹⁸ ; Shun YUE ¹⁹ ; Bangwei CAO ²⁰ ; Yuping SUN ²¹ ; Shu WANG ²² ; Zhongsheng TONG ²³ ; Peng SHEN ²⁴ ; Gang WU ²⁵ ; Lili TANG ²⁶ ; Yongchuan DENG ²⁷ ; Liqun JIA ²⁸ ; Kunwei SHEN ²⁹ ; Wu ZHUANG ³⁰ ; Xiaodong XIE ³¹ ; Youhua WU ³² ; Lin CHEN ³³
Author Information

1. Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences, Beijing 100021, China.
2. Department of Breast Surgery, Shanxi Province Cancer Center, Taiyuan 030013, China.
3. Department of Oncology, Sichuan Provincial Tumor Hospital, Chengdu 610041, China.
4. Cancer Center, the First Hospital of Jilin University, Changchun 130021, China.
5. Department of Oncology, Cancer Hospital of Linyi City, Linyi 276001, China.
6. Department of Oncology, Lanzhou General Hospital, Lanzhou Command, Lanzhou 730050, China.
7. Department of Oncology, Shanxi Provincial Tumor Hospital Xi'an 710061, China.
8. Department of Oncology, the Second People's Hospital of Yibin City, Yibin 644000, China.
9. Department of Oncology, Cancer Hospital of Bengbu Medical College, Bengbu 233004, China.
10. Department of Oncology, Cancer Hospital of Harbin Medical University, Harbin 150081, China.
11. Department of Oncology, the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, China.
12. Department of Breast Surgery, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
13. Department of Oncology, the People's Hospital of Tianjin City, Tianjin 300121, China.
14. Department of Oncology, the First People's Hospital of Yueyang City, Yueyang 414000, China.
15. Cancer Therapy & Research Center, Jinan Military Command General Hospital, Jinan 250012, China.
16. Department of Oncology, Central Hospital of Siping City, Siping 136000, China.
17. Department of Oncology, Beijing Chaoyang Hospital of Capital Medical University, Beijing 100020, China.
18. Department of General Surgery, Beijing Chaoyang Hospital of Capital Medical University, Beijing 100020, China.
19. Department of Oncology, the First Hospital of Huai'an City, Nanjing Medical University, Nanjing 223300, China.
20. Department of Oncology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China.
21. Department of Oncology, Jinan City Central Hospital, Jinan 250015, China.
22. Department of Breast Surgery, Peking University People's Hospital, Beijing 100044, China.
23. Department of Breast Cancer, Cancer Hospital of Tianjin City, Tianjin 300060, China.
24. Department of Chemotherapy, the First Affiliated Hospital of Zhejiang University, Hangzhou 310003, China.
25. Cancer Center, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.
26. Department of Breast Cancer, Xiangya Hospital, Central South University, Changsha 410008, China.
27. Department of Oncological Surgery, the Second Affiliated Hospital, Zhejiang University, Hangzhou 310009, China.
28. Department of Oncology, China-Japan Friendship Hospital, Beijing 100029, China.
29. Department of Breast Surgery, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China.
30. Department of Thoracic Oncology, Fujian Provincial Cancer Hospital, Fuzhou 350014, China.
31. Department of Oncology, the General Hospital of PLA Shenyang Military Command, Shenyang 110015, China.
32. Department of Oncology, the First Affiliated Hospital of Nanhua University, Hengyang 421001, China.
33. Department of Oncology, People's Hospital of Sichuan Province, Chengdu 610000, China.
Publication Type:Journal Article
MeSH: Antineoplastic Agents; adverse effects; therapeutic use; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; drug therapy; Carboplatin; administration & dosage; adverse effects; Carcinoma, Non-Small-Cell Lung; drug therapy; Cyclophosphamide; administration & dosage; adverse effects; Epirubicin; administration & dosage; adverse effects; Female; Granulocyte Colony-Stimulating Factor; therapeutic use; Humans; Incidence; Induction Chemotherapy; Lung Neoplasms; drug therapy; Neutropenia; chemically induced; epidemiology; prevention & control; Polyethylene Glycols; Recombinant Proteins; administration & dosage; Taxoids; administration & dosage; adverse effects
From: Chinese Journal of Oncology 2016;38(1):23-27
CountryChina
Language:Chinese
Abstract:
OBJECTIVETo 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.
METHODSAccording 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.
RESULTSThe 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).
CONCLUSIONSIn 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.