title: NADIR: A Non-Interventional Study on the Prophylaxis of Chemotherapy-Induced Neutropenia Using Lipegfilgrastim - First Interim Analysis.
abstract: BACKGROUND
  The non-interventional study (NIS) NADIR was designed to assess the effectiveness and safety of lipegfilgrastim, a novel glycopegylated granulocyte-colony stimulating factor, in reducing the risk of both febrile and severe neutropenia.
  
  
  METHODS
  Here, the interim analysis of NIS Nadir performed under real-world conditions at 80 oncology practices across Germany is reported. For a patient to be included, lipegfilgrastim at a subcutaneous single dose of 6 mg had to be administered during at least 1 cycle of the chemotherapy under consideration.
  
  
  RESULTS
  The interim analysis included 224 patients. Median patient age was 61.1 years (interquartile range 51.2-70.2 years). Main tumor type was breast cancer followed by lung cancer, and non-Hodgkin's lymphoma (46.0, 13.4, and 10.7%, respectively). When lipegfilgrastim was given as primary prophylaxis, no patient developed febrile neutropenia (FN). 1.3% of patients developed FN when primary prophylaxis was withheld. Only 68.6% of patients undergoing chemotherapy and at high risk (> 20%) of developing FN were treated with lipegfilgrastim during the first cycle, exposing disparity between real-world practices and current treatment guidelines. Lipegfilgrastim was well tolerated. The only grade 3/4 treatment-related adverse event was anemia in 1 patient.
  
  
  CONCLUSIONS
  Lipegfilgrastim was effective and safe when administered for the prevention of chemotherapy-induced neutropenia under real-world conditions.
authors.affiliation: Gynäkologisches Zentrum Bonn-Friedensplatz, Bonn, Germany.
authors.forename: Christian M
authors.initials: CM
authors.lastname: Kurbacher
authors.forename: Thomas
authors.initials: T
authors.lastname: Fietz
authors.forename: Ingo J
authors.initials: IJ
authors.lastname: Diel
authors.forename: Matthias
authors.initials: M
authors.lastname: Egert
authors.forename: Hans-Jürgen
authors.initials: HJ
authors.lastname: Hurtz
authors.forename: Andreas
authors.initials: A
authors.lastname: Lück
authors.forename: Rudolf
authors.initials: R
authors.lastname: Weide
authors.forename: Christoph
authors.initials: C
authors.lastname: Salat
authors.forename: Thomas
authors.initials: T
authors.lastname: Wolff
authors.forename: Matthias
authors.initials: M
authors.lastname: Zaiss
authors.forename: Peter
authors.initials: P
authors.lastname: Klare
authors.forename: Christoph
authors.initials: C
authors.lastname: Losem
authors.forename: Thomas
authors.initials: T
authors.lastname: Illmer
authors.forename: Georg
authors.initials: G
authors.lastname: Weißenborn
authors.forename: Claus-Christoph
authors.initials: CC
authors.lastname: Steffens
authors.forename: Matthias
authors.initials: M
authors.lastname: Schulze
authors.forename: Hans
authors.initials: H
authors.lastname: Tesch
authors.forename: Gülten
authors.initials: G
authors.lastname: Oskay-Oezcelik
authors.forename: Beate
authors.initials: B
authors.lastname: Teichmann
authors.forename: Johanna
authors.initials: J
authors.lastname: Harde
authors.forename: Robert Willy
authors.initials: RW
authors.lastname: Scheuerlein
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols; D011994:Recombinant Proteins / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim