Abstract
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. 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. 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 ...Continue Reading
References
Jul 18, 1991·The New England Journal of Medicine·J CrawfordG Rausch
Feb 1, 1966·Annals of Internal Medicine·G P BodeyE J Freireich
Jan 11, 2002·The New England Journal of Medicine·Joan H SchillerUNKNOWN Eastern Cooperative Oncology Group
Feb 1, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·F A HolmesB C Liang
Dec 10, 2002·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·Ronald FeldUNKNOWN Multinational Association for Supportive Care in Cancer
Dec 19, 2002·Annals of Oncology : Official Journal of the European Society for Medical Oncology·M D GreenUNKNOWN International Pegfilgrastim 749 Study Group
Jul 3, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Frank FossellaChandra P Belani
May 1, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Nasser HannaPaul A Bunn
Feb 19, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Charles L VogelLee S Schwartzberg
May 10, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Thomas J SmithAntonio C Wolff
May 12, 2006·The New England Journal of Medicine·Kenneth Kaushansky
May 16, 2006·Critical Reviews in Oncology/hematology·Francesco Grossi, Marcello Tiseo
Aug 4, 2006·The New England Journal of Medicine·Gianluigi FerrettiFrancesco Cognetti
Feb 20, 2007·Lung Cancer : Journal of the International Association for the Study of Lung Cancer·Yuh-Min ChenJacqueline Whang-Peng
Sep 3, 2009·Journal of Medical Economics·Dawn HershmanJennifer L Malin
Apr 10, 2010·Clinical Colorectal Cancer·J Randolph HechtImtiaz Malik
Nov 26, 2010·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·M S AaproUNKNOWN European Organisation for Research and Treatment of Cancer
Feb 8, 2011·CA: a Cancer Journal for Clinicians·Ahmedin JemalDavid Forman
Oct 3, 2013·Asian Pacific Journal of Tropical Medicine·Bo YanLi-Yan Jiang
Oct 7, 2014·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Alena M PfeilZsolt Szabo
Jul 15, 2015·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Thomas J SmithJames O Armitage
Citations
Sep 7, 2019·Clinical Drug Investigation·Zaina T Al-Salama, Susan J Keam
Aug 31, 2019·BMJ Supportive & Palliative Care·Lei LiJinghe Lang
Oct 28, 2019·Scientific Reports·Yong WangYong Li
Feb 8, 2019·BMC Cancer·Zsuzsanna KahanIldiko Aradi
Jun 5, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Jichun YangFeng Sun
Feb 17, 2021·Thoracic Cancer·Chang LiuDiansheng Zhong
May 16, 2021·Journal of Oncology Pharmacy Practice : Official Publication of the International Society of Oncology Pharmacy Practitioners·José Cleberson Santos SoaresJuliana Lúcia de Albuquerque Vasconcelos
Jun 4, 2021·BMC Cancer·Dongling ZouQi Zhou
Jun 12, 2021·Expert Review of Anticancer Therapy·Michelle ShayneGary H Lyman
Oct 8, 2021·Cancer Chemotherapy and Pharmacology·Hsuan-Ming YaoFaith D Ottery
Dec 24, 2021·Medicine·Genzhu WangZhongdong Li