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)
机构：[1]Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School ofMedicine, Shanghai, China[2]Department of Thoracic Surgery, Cancer Hospital of Yunnan Provience, Kunming,China[3]Department of Oncology, Chongqing Cancer Hospital, Chongqing, China[4]Department of Respiration Medicine, Yanbian University Hospital, Yanbian, China[5]Department of Radiotherapy and Chemotherapy, Zhongnan Hospital of WuhanUniversity, Wuhan, China[6]Department of Respiration Medicine, The Second Affiliated Hospital of Xi’an JiaotongUniversity, Xian, China[7]Department of Respiration Oncology, Harbin Medical University Cancer Hospital,Harbin, China[8]Department of Oncology, The First People’s Hospital of Changzhou, Changzhou,China[9]Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou MedicalUniversity, Guangzhou, China[10]Department of Oncology, Wuhan Union Hospital, Wuhan, China华中科技大学同济医学院附属协和医院[11]Department of RespirationMedicine, Cancer Hospital of Shanxi Provence, Taiyuan, China[12]Department ofOncology,Wuhan GeneralHospital ofGuangzhou Military,Wuhan, China[13]Department of Oncology, Tumor Hospital of Hebei Provence, Shijiazhuang, China河北医科大学第四医院[14]Department of General Medicine, Beijing Chest Hospital, Capital Medical University,Beijing, China[15]Department of Oncology, Linyi Cancer Hospital, Linyi, China[16]Department of Oncology, Fujian Provincial Cancer Hospital, Fuzhou, China[17]Department of Oncology, The Second People’s Hospital of Sichuan, Chengdu, China[18]Department of Oncology, Wuhan Puai Hospital, Wuhan, China[19]Department of RespirationMedicine, The First Hospital of Lanzhou University, Lanzhou,China[20]Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China[21]Department of Statistics, The Fourth Military Medical University, Xi’an, China
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. Background: Mecapegfilgrastim (code name HHPG-19K) is a biosimilar to pegylated recombinant human granulocyte-colony stimulating factor (PEG-rhG-CSF). The efficacy and safety of mecapegfilgrastim, using a regimen of once-per-cycle injection of 100-mu g/kg or a fixed 6-mg dose, were evaluated for the prophylactic therapy for neutropenia in patients with advanced non-small-cell lung cancer (NSCLC) who were treated with myelosuppressive chemotherapy. Materials and Methods: Patients were randomized (1:1:1) blindly to 3 treatment arms to receive a single injection of mecapegfilgrastim 100 mu g/kg, a 6-mg fixed dose of mecapegfilgrastim, or saline (control) in cycle 1. In cycles 2 to 4 following unblinding at the end of cycle 1, patients in the control arm received daily injections of short-acting rhG-CSF at a dose of 5 mu g/kg, whereas patients in the 2 mecapegfilgrastim arms continued the same treatment as in cycle 1. All patients received 4 chemotherapy cycles of docetaxel combined with cisplatin or carboplatin every 21 days. The primary endpoint was the incidence of grade >= 3 neutropenia in cycle 1. Results: A single dose of 100 mu g/kg or a fixed 6-mg dose of mecapegfilgrastim per cycle effectively reduced chemotherapy-induced neutropenia and was comparable to daily rhG-CSF with regard to all efficacy endpoints, including incidence of grade >= 3 neutropenia, incidence of febrile neutropenia, duration of grade >= 3 neutropenia, and time to neutrophil recovery. No difference in efficacy parameters was observed between the 2-dose regimens of mecapegfilgrastim across all cycles. Mecapegfilgrastim was well-tolerated and was as safe as daily rhG-CSF. Conclusion: Once-per-cycle injection of mecapegfilgrastim is as effective and safe as daily rhG-CSF for prophylaxis of chemotherapy-induced neutropenia in patients with NSCLC. Mecapegfilgrastim (fixed 6-mg dose) is recommended in clinical practice for its convenient dose management. (C) 2016 Published by Elsevier Inc. All rights reserved.
基金：
National Science and Technology Major
Projects for Major New Drugs Innovation and Development
(2013ZX09402-102) and Technology-to-Production Conversion
Project of Jiangsu Province (Class A) (BA2013013).
第一作者机构：[1]Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School ofMedicine, Shanghai, China[*1]Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, No.507 Zhengmin Road, Yangpu District, Shanghai, China 200433
通讯作者：
通讯机构：[1]Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School ofMedicine, Shanghai, China[*1]Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, No.507 Zhengmin Road, Yangpu District, Shanghai, China 200433
推荐引用方式(GB/T 7714)：
Zhou Caicun,Huang Yunchao,Wang Donglin,et al.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].CLINICAL LUNG CANCER.2016,17(2):119-127.doi:10.1016/j.cllc.2015.12.002.
APA：
Zhou, Caicun,Huang, Yunchao,Wang, Donglin,An, Changshan,Zhou, Fuxiang...&Xia, Jielai.(2016).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).CLINICAL LUNG CANCER,17,(2)
MLA：
Zhou, Caicun,et al."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)".CLINICAL LUNG CANCER 17..2(2016):119-127
