title: XM02, the first biosimilar G-CSF, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with small cell or non-small cell lung cancer receiving platinum-based chemotherapy.
abstract: BACKGROUND
  Recombinant granulocyte colony-stimulating factors such as Neupogen are used to treat chemotherapy-induced neutropenia. The aim of the study was to show that a new granulocyte colony-stimulating factor, XM02, is as safe and effective as Neupogen in the treatment of chemotherapy-induced neutropenia in patients with small cell or non-small cell lung cancer.
  
  
  METHODS
  A total of 240 patients receiving platinum-based chemotherapy were randomized in cycle 1 to treatment with daily injections (subcutaneous 5 microg/kg/d) of XM02 (n = 160) or Filgrastim Neupogen (n = 80) for at least 5 days and a maximum of 14 days. In subsequent cycles, all patients received XM02.
  
  
  RESULTS
  The mean duration of severe neutropenia was 0.5 and 0.3 days in cycle 1 for XM02 and Filgrastim, respectively. In the analysis of covariance for duration of severe neutropenia in cycle 1, the estimated treatment difference "XM02 minus Filgrastim" was 0.157 days, with 95% confidence level (-0.114 days, 0.428 days), which was included in the prespecified equivalence range (-1, 1). There was no statistically significant difference of the end point incidence of febrile neutropenia in cycle 1 between XM02 and Filgrastim (p = 0.2347). The adverse event profile was similar between XM02 and Filgrastim.
  
  
  CONCLUSIONS
  XM02 demonstrated similar efficacy and safety profile as the reference medication Filgrastim in cycle 1. In conclusion, treatment with XM02 is beneficial in ameliorating severe neutropenia and febrile neutropenia in lung cancer patients receiving myelosuppressive chemotherapy. XM02 is safe and well tolerated in the doses applied in this study.
authors.affiliation: Center of Pneumology and Thoracic Surgery, Department of Thoracic Surgery, Grosshansdorf, Germany. pneumo.onko@t-online.de
authors.forename: Ulrich
authors.initials: U
authors.lastname: Gatzemeier
authors.forename: Tudor
authors.initials: T
authors.lastname: Ciuleanu
authors.forename: Mircea
authors.initials: M
authors.lastname: Dediu
authors.forename: Elena
authors.initials: E
authors.lastname: Ganea-Motan
authors.forename: Heinz
authors.initials: H
authors.lastname: Lubenau
authors.forename: Auro
authors.initials: A
authors.lastname: Del Giglio
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000556:secondary / Q000628:therapy*; D003131:Combined Modality Therapy; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000188:drug therapy* / Q000453:epidemiology; D009944:Organoplatinum Compounds / Q000627:therapeutic use*; D011379:Prognosis; D011994:Recombinant Proteins; D055752:Small Cell Lung Carcinoma / Q000556:secondary / Q000628:therapy*; D015996:Survival Rate; D013810:Therapeutic Equivalency; D016896:Treatment Outcome
chemical_list: D009944:Organoplatinum Compounds; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim