title: Phase III placebo-controlled, double-blind, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in breast cancer patients receiving docetaxel/cyclophosphamide chemotherapy.
abstract: OBJECTIVE
  Pegfilgrastim is a pegylated form of filgrastim, a recombinant protein of granulocyte colony-stimulating factor, that is used to reduce the risk of febrile neutropenia (FN). Here, we report the results of a phase III trial of pegfilgrastim in breast cancer patients receiving docetaxel and cyclophosphamide (TC) chemotherapy.
  
  
  METHODS
  We conducted a double-blind, placebo-controlled, randomized trial to determine the efficacy of pegfilgrastim in reducing the risk of FN in early-stage breast cancer patients. A total of 351 women (177 in the pegfilgrastim group and 174 in the placebo group) between 20 and 69 years of age with stage I-III invasive breast carcinoma who were to receive TC chemotherapy (docetaxel 75 mg/m(2) and cyclophosphamide 600 mg/m(2) every 3 weeks) as either neoadjuvant or adjuvant therapy were enrolled; 346 of these patients were treated with either pegfilgrastim (n = 173) or placebo (n = 173).
  
  
  RESULTS
  The incidence of FN was significantly lower in the pegfilgrastim group than in the placebo group (1.2 vs. 68.8 %, respectively; P < 0.001). In addition, patients in the pegfilgrastim group required less hospitalization and antibiotics for FN. Most adverse events were consistent with those expected for breast cancer subjects receiving TC chemotherapy.
  
  
  CONCLUSIONS
  Pegfilgrastim is safe and significantly reduces the incidence of FN in breast cancer patients.
authors.affiliation: Department of Surgery, School of Medicine, Kitasato University, Sagamihara, Japan, y-kosaka@med.kitasato-u.ac.jp.
authors.forename: Yoshimasa
authors.initials: Y
authors.lastname: Kosaka
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Rai
authors.forename: Norikazu
authors.initials: N
authors.lastname: Masuda
authors.forename: Toshimi
authors.initials: T
authors.lastname: Takano
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Saeki
authors.forename: Seigo
authors.initials: S
authors.lastname: Nakamura
authors.forename: Ryutaro
authors.initials: R
authors.lastname: Shimazaki
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Ito
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tokuda
authors.forename: Kazuo
authors.initials: K
authors.lastname: Tamura
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000188:drug therapy* / Q000517:prevention & control; D003520:Cyclophosphamide / Q000009:adverse effects; D004311:Double-Blind Method; D004317:Doxorubicin / Q000009:adverse effects; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D011092:Polyethylene Glycols; D011379:Prognosis; D011994:Recombinant Proteins / Q000008:administration & dosage; D012306:Risk; D015996:Survival Rate; D043823:Taxoids / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D004317:Doxorubicin; D003520:Cyclophosphamide; D000069585:Filgrastim