title: 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).
abstract: 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-μg/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.
  
  
  METHODS
  Patients were randomized (1:1:1) blindly to 3 treatment arms to receive a single injection of mecapegfilgrastim 100 μg/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 μg/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 μg/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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China. Electronic address: zhoucc150602@163.com.
authors.forename: Caicun
authors.initials: C
authors.lastname: Zhou
authors.affiliation: Department of Thoracic Surgery, Cancer Hospital of Yunnan Provience, Kunming, China.
authors.forename: Yunchao
authors.initials: Y
authors.lastname: Huang
authors.affiliation: Department of Oncology, Chongqing Cancer Hospital, Chongqing, China.
authors.forename: Donglin
authors.initials: D
authors.lastname: Wang
authors.affiliation: Department of Respiration Medicine, Yanbian University Hospital, Yanbian, China.
authors.forename: Changshan
authors.initials: C
authors.lastname: An
authors.affiliation: Department of Radiotherapy and Chemotherapy, Zhongnan Hospital of Wuhan University, Wuhan, China.
authors.forename: Fuxiang
authors.initials: F
authors.lastname: Zhou
authors.affiliation: Department of Respiration Medicine, The Second Affiliated Hospital of Xi'an Jiaotong University, Xian, China.
authors.forename: Yali
authors.initials: Y
authors.lastname: Li
authors.affiliation: Department of Respiration Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
authors.forename: Gongyan
authors.initials: G
authors.lastname: Chen
authors.affiliation: Department of Oncology, The First People's Hospital of Changzhou, Changzhou, China.
authors.forename: Changping
authors.initials: C
authors.lastname: Wu
authors.affiliation: Department of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
authors.forename: Jianxing
authors.initials: J
authors.lastname: He
authors.affiliation: Department of Oncology, Wuhan Union Hospital, Wuhan, China.
authors.forename: Gang
authors.initials: G
authors.lastname: Wu
authors.affiliation: Department of Respiration Medicine, Cancer Hospital of Shanxi Provence, Taiyuan, China.
authors.forename: Xia
authors.initials: X
authors.lastname: Song
authors.affiliation: Department of Oncology, Wuhan General Hospital of Guangzhou Military, Wuhan, China.
authors.forename: Jianfei
authors.initials: J
authors.lastname: Gao
authors.affiliation: Department of Oncology, Tumor Hospital of Hebei Provence, Shijiazhuang, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Liu
authors.affiliation: Department of General Medicine, Beijing Chest Hospital, Capital Medical University, Beijing, China.
authors.forename: Baolan
authors.initials: B
authors.lastname: Li
authors.affiliation: Department of Oncology, Linyi Cancer Hospital, Linyi, China.
authors.forename: Jianhua
authors.initials: J
authors.lastname: Shi
authors.affiliation: Department of Oncology, Fujian Provincial Cancer Hospital, Fuzhou, China.
authors.forename: Cheng
authors.initials: C
authors.lastname: Huang
authors.affiliation: Department of Oncology, The Second People's Hospital of Sichuan, Chengdu, China.
authors.forename: Jingrui
authors.initials: J
authors.lastname: Yu
authors.affiliation: Department of Oncology, Wuhan Puai Hospital, Wuhan, China.
authors.forename: Jueping
authors.initials: J
authors.lastname: Feng
authors.affiliation: Department of Respiration Medicine, The First Hospital of Lanzhou University, Lanzhou, China.
authors.forename: Hongmei
authors.initials: H
authors.lastname: Yue
authors.affiliation: Department of Oncology, Jiangsu Cancer Hospital, Nanjing, China.
authors.forename: Meiqi
authors.initials: M
authors.lastname: Shi
authors.affiliation: Department of Statistics, The Fourth Military Medical University, Xi'an, China.
authors.forename: Jielai
authors.initials: J
authors.lastname: Xia
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D059451:Biosimilar Pharmaceuticals / Q000008:administration & dosage*; D018288:Carcinoma, Small Cell / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D002681:China; D002985:Clinical Protocols; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008175:Lung Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D038042:Myelopoiesis / Q000187:drug effects; D009367:Neoplasm Staging; D009503:Neutropenia / Q000209:etiology / Q000517:prevention & control*; D009504:Neutrophils / Q000187:drug effects* / Q000502:physiology; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D011994:Recombinant Proteins / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D059451:Biosimilar Pharmaceuticals; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D011092:Polyethylene Glycols; C423652:pegylated granulocyte colony-stimulating factor
keywords: Clinical trial; Efficacy; Granulocyte-colony stimulating factor; Long-acting PEG-rhG-CSF; Safety