A Randomized Multicenter Phase III Study of Single Administration of Mecapegfilgrastim (HHPG-19K), a Pegfilgrastim Biosimilar, for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)

Zhou Caicun; Huang Yunchao; Wang Donglin; An Changshan; Zhou Fuxiang; Li Yali; Chen Gongyan; Wu Changping; He Jianxing; Wu Gang; Song Xia; Gao Jianfei; Liu Wei; Li Baolan; Shi Jianhua; Huang Chen; Yu Jingrui; Feng Jueping; Yue Hongmei; Shi Meiqi; Xia Jielai

首页> 外文期刊>Clinical lung cancer >A Randomized Multicenter Phase III Study of Single Administration of Mecapegfilgrastim (HHPG-19K), a Pegfilgrastim Biosimilar, for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)

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A Randomized Multicenter Phase III Study of Single Administration of Mecapegfilgrastim (HHPG-19K), a Pegfilgrastim Biosimilar, for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)

机译：单次施用麦克风植物生物素（HHPG-19K）的随机多中心研究III研究，佩格菲尔群生物蛋白，用于预防非小细胞肺癌（NSCLC）的化疗诱导的中性粒细胞缺陷症的预防

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The efficacy and safety profile of mecapegfilgrastim for prophylactic use in patients with NSCLC was evaluated in this 2-stage study. From the double-blind stage and open-label stage, the efficacy of mecapegfilgrastim and short-action granulocyte colony-stimulating factor was compared, and the exact incidence of neutropenia and febrile neutropenia in this population was well studied.

机译：在该2阶段研究中，评估了MeCapegfilgrastim用于预防NSCLC患者的预防性用途的疗效和安全性。从双盲阶段和开放标签阶段，比较了MeCapegfilGrastim和短动作粒细胞菌落刺激因子的疗效，并且研究了细胞纤维尼亚和发热中性粒细胞率的精确发生率。

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来源
《Clinical lung cancer》 |2016年第2期|共9页
作者
Zhou Caicun; Huang Yunchao; Wang Donglin; An Changshan; Zhou Fuxiang; Li Yali; Chen Gongyan; Wu Changping; He Jianxing; Wu Gang; Song Xia; Gao Jianfei; Liu Wei; Li Baolan; Shi Jianhua; Huang Chen; Yu Jingrui; Feng Jueping; Yue Hongmei; Shi Meiqi; Xia Jielai;
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作者单位

Tongji Univ Sch Med Shanghai Pulm Hosp Dept Oncol 507 Zhengmin Rd Shanghai 200433 Peoples R;

Canc Hosp Yunnan Prov Dept Thorac Surg Kunming Peoples R China;

Chongqing Canc Hosp Dept Oncol Chongqing Peoples R China;

Yanbian Univ Hosp Dept Respirat Med Yanbian Peoples R China;

Wuhan Univ Zhongnan Hosp Dept Radiotherapy &

Chemotherapy Wuhan 430072 Peoples R China;

Xi An Jiao Tong Univ Affiliated Hosp 2 Dept Resp Med Xian 710049 Peoples R China;

Harbin Med Univ Canc Hosp Dept Resp Oncol Harbin Peoples R China;

First Peoples Hosp Changzhou Dept Oncol Changzhou Peoples R China;

Guangzhou Med Univ Affiliated Hosp 1 Dept Thorac Surg Guangzhou Guangdong Peoples R China;

Wuhan Union Hosp Dept Oncol Wuhan Peoples R China;

Canc Hosp Shanxi Provence Dept Respirat Med Taiyuan Peoples R China;

Wuhan Gen Hosp Guangzhou Mil Dept Oncol Wuhan Peoples R China;

Tumor Hosp Hebei Provence Dept Oncol Shijiazhuang Peoples R China;

Capital Med Univ Beijing Chest Hosp Dept Gen Med Beijing Peoples R China;

Linyi Canc Hosp Dept Oncol Linyi Peoples R China;

Fujian Prov Canc Hosp Dept Oncol Fuzhou Peoples R China;

Second Peoples Hosp Sichuan Dept Oncol Chengdu Peoples R China;

Wuhan Puai Hosp Dept Oncol Wuhan Peoples R China;

Lanzhou Univ Hosp 1 Dept Resp Med Lanzhou 730000 Peoples R China;

Jiangsu Canc Hosp Dept Oncol Nanjing Jiangsu Peoples R China;

Fourth Mil Med Univ Dept Stat Xian 710032 Peoples R China;

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原文格式 PDF
正文语种 eng
中图分类肿瘤学;
关键词
Clinical trial; Efficacy; Granulocyte-colony stimulating factor; Long-acting PEG-rhG-CSF; Safety;

机译：临床试验;疗效;粒细胞殖民刺激因子;长效PEG-RHG-CSF;安全;

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外文文献

1. A Randomized Multicenter Phase III Study of Single Administration of Mecapegfilgrastim (HHPG-19K), a Pegfilgrastim Biosimilar, for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC) [J] . Zhou Caicun, Huang Yunchao, Wang Donglin, Clinical lung cancer . 2016,第2期

机译：单一给药美格非非司亭生物仿制药美卡培非司亭（HHPG-19K）预防晚期非小细胞肺癌（NSCLC）化疗引起的中性粒细胞减少的随机多中心III期研究
2. Efficacy and safety of RGB-02, a pegfilgrastim biosimilar to prevent chemotherapy-induced neutropenia: results of a randomized, double-blind phase III clinical study vs. reference pegfilgrastim in patients with breast cancer receiving chemotherapy [J] . Zsuzsanna Kahan, Daniela Grecea, Martin Smakal, BMC Cancer . 2019,第1期

机译：RGB-02的功效和安全性，Pegfilgrastim BioSimilar，以防止化疗诱导的中性粒细胞率：随机，双盲期III临床研究的结果与接受化疗的乳腺癌患者参考PEGFILRASTIM
3. A randomized, multicenter, phase II/III study to determine the optimal dose and to evaluate the efficacy and safety of pegteograstim (GCPGC) on chemotherapy-induced neutropenia compared to pegfilgrastim in breast cancer patients: KCSG PC10-09 [J] . Lee Ki Hyeong, Kim Ji-Yeon, Lee Moon Hee, Supportive care in cancer: official journal of the Multinational Association of Supportive Care in Cancer . 2016,第4期

机译：一项随机，多中心，II / III期研究，用于确定最佳剂量，并评估与pegfilgrastim相比，pegfilgrastim对乳腺癌患者的pegteograstim（GCPGC）化疗所致中性粒细胞减少的疗效和安全性：KCSG PC10-09
4. Erratum to efficacy and safety of mecapegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer: a randomized multicenter active-controlled phase III trial [O] . Fengrui Xu, Yang Zhang, Zhanhui Miao, 2020

机译：评估美卡培非酯预防乳腺癌患者化疗引起的中性粒细胞减少的功效和安全性：一项随机多中心主动控制的III期临床试验
5. Efficacy and safety of mecapegfilgrastim for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer: a randomized, multicenter, active-controlled phase III trial [O] . Fengrui Xu, Yang Zhang, Zhanhui Miao, 2019

机译：MeCapegfilgrastim对乳腺癌患者的化疗诱导的中性粒细胞缺血预防的疗效和安全性：随机，多中心，主动控制的III阶段试验

A Randomized Multicenter Phase III Study of Single Administration of Mecapegfilgrastim (HHPG-19K), a Pegfilgrastim Biosimilar, for Prophylaxis of Chemotherapy-Induced Neutropenia in Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC)

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