title: Febrile neutropenia and related complications in breast cancer patients receiving pegfilgrastim primary prophylaxis versus current practice neutropaenia management: results from an integrated analysis.
abstract: Granulocyte colony-stimulating factors (G-CSFs) reduce febrile neutropaenia (FN) incidence but may be used inconsistently in current practice (CP). This study compared the efficacy of pegfilgrastim primary prophylaxis (PPP) with CP neutropaenia management in breast cancer. Individual patient data (N=2282) from 11 clinical trials and observational studies using chemotherapy regimens with > or =15% FN risk and PPP (6 mg, all cycles) or CP (no G-CSF or any cycle G-CSF/pegfilgrastim) were included in an integrated analysis. Most patients received docetaxel-containing regimens. A generalised linear mixed model was fitted (N=2210). Neutropaenia prophylaxis (PPP versus CP), age and disease stage influenced the incidence of FN. Overall, FN was less frequent with PPP than with CP (odds ratio [OR]: 0.124; 95% confidence interval [CI]: 0.08, 0.194; P<0.0001). Odds for cycle 1 FN, dose reductions > or =15% and FN-related hospitalisation were also significantly lower with PPP. These data support PPP in breast cancer patients receiving chemotherapy with moderately high/high FN risk.
authors.affiliation: German Breast Group, c/o GBG Forschungs GmbH, University of Frankfurt, Frankfurt, Schleussner Str. 42, 63263 Neu-Isenburg, Germany. Minckwitz@germanbreastgroup.de
authors.forename: G
authors.initials: G
authors.lastname: von Minckwitz
authors.forename: M
authors.initials: M
authors.lastname: Schwenkglenks
authors.forename: T
authors.initials: T
authors.lastname: Skacel
authors.forename: G H
authors.initials: GH
authors.lastname: Lyman
authors.forename: A Lopez
authors.initials: AL
authors.lastname: Pousa
authors.forename: P
authors.initials: P
authors.lastname: Bacon
authors.forename: V
authors.initials: V
authors.lastname: Easton
authors.forename: M S
authors.initials: MS
authors.lastname: Aapro
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000517:prevention & control*; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D009894:Opportunistic Infections / Q000517:prevention & control; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D000069585:Filgrastim