title: Pegfilgrastim +/- ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO study.
abstract: BACKGROUND
  TAC (docetaxel/doxorubicin/cyclophosphamide) is associated with high incidences of grade 4 neutropenia and febrile neutropenia (FN). This analysis compared the efficacies of four regimens for primary prophylaxis of FN and related toxic effects in breast cancer patients receiving neoadjuvant TAC.
  
  
  METHODS
  Patients with stage T2-T4 primary breast cancer were scheduled to receive 6-8 cycles of TAC. Primary prophylaxis was: ciprofloxacin 500 mg orally twice daily on days 5-14 (n = 253 patients; 1478 cycles), daily granulocyte colony-stimulating factor (G-CSF) (filgrastim 5 microg/kg/day or lenograstim 150 microg/m(2)/day) on days 5-10 (n = 377; 2400 cycles), pegfilgrastim 6 mg on day 2 (n = 305; 1930 cycles), or pegfilgrastim plus ciprofloxacin (n = 321; 1890 cycles).
  
  
  RESULTS
  Pegfilgrastim with/without ciprofloxacin was significantly more effective than daily G-CSF or ciprofloxacin in preventing FN (5% and 7% versus 18% and 22% of patients; all P < 0.001), grade 4 neutropenia, and leukopenia. Pegfilgrastim plus ciprofloxacin completely prevented first cycle FN (P < 0.01 versus pegfilgrastim alone) and fatal neutropenic events.
  
  
  CONCLUSIONS
  Ciprofloxacin alone, or daily G-CSF from day 5-10 (as in common practice), provided suboptimal protection against FN and related toxic effects in patients receiving TAC. Pegfilgrastim was significantly more effective in this setting, especially if given with ciprofloxacin.
authors.affiliation: German Breast Group, Neu-Isenburg, Germany. minckwitz@germanbreastgroup.de
authors.forename: G
authors.initials: G
authors.lastname: von Minckwitz
authors.forename: S
authors.initials: S
authors.lastname: Kümmel
authors.forename: A
authors.initials: A
authors.lastname: du Bois
authors.forename: W
authors.initials: W
authors.lastname: Eiermann
authors.forename: H
authors.initials: H
authors.lastname: Eidtmann
authors.forename: B
authors.initials: B
authors.lastname: Gerber
authors.forename: J
authors.initials: J
authors.lastname: Hilfrich
authors.forename: J
authors.initials: J
authors.lastname: Huober
authors.forename: S D
authors.initials: SD
authors.lastname: Costa
authors.forename: C
authors.initials: C
authors.lastname: Jackisch
authors.forename: S-T
authors.initials: ST
authors.lastname: Grasshoff
authors.forename: S
authors.initials: S
authors.lastname: Vescia
authors.forename: T
authors.initials: T
authors.lastname: Skacel
authors.forename: S
authors.initials: S
authors.lastname: Loibl
authors.forename: K M
authors.initials: KM
authors.lastname: Mehta
authors.forename: M
authors.initials: M
authors.lastname: Kaufmann
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D002939:Ciprofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D000069585:Filgrastim; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D015999:Multivariate Analysis; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D010865:Pilot Projects; D011092:Polyethylene Glycols; D011336:Probability; D011994:Recombinant Proteins; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; C455861:pegfilgrastim; D011092:Polyethylene Glycols; D002939:Ciprofloxacin; D004317:Doxorubicin; D003520:Cyclophosphamide; D000069585:Filgrastim