title: Primary G-CSF prophylaxis for adjuvant TC or FEC-D chemotherapy outside of clinical trial settings: a systematic review and meta-analysis.
abstract: BACKGROUND
  Variable febrile neutropenia (FN) rates reported with adjuvant TC (taxotere®, cyclophosphamide) and FEC-D (5-flurouracil, epirubicin, cyclophosphamide, docetaxel) outside of clinical trials have precluded definitive recommendations for primary G-CSF (granulocyte colony-stimulating factor) prophylaxis in most jurisdictions. A systematic review and meta-analysis was conducted to assess: (a) FN rates associated with TC and FEC-D without primary G-CSF prophylaxis outside of clinical trial settings, and (b) the potential impact of G-CSF prophylaxis on FN prevention.
  
  
  METHODS
  A MEDLINE search was conducted and major conference abstracts were reviewed up to June 15th 2011 to identify all relevant English-language studies. Random- and fixed-effects meta-analysis models were performed.
  
  
  RESULTS
  Nine hundred two patients treated with TC and 1342 with FEC-D from 13 to 9 studies, respectively, were included. The pooled random-effects meta-analysis estimates of FN rates for TC and FEC-D without G-CSF were 29% (95% CI 24-35%) and 31% (95% CI 27-35%), with a 76% (RR = 0.24, 95% CI 0.14-0.41) and 63% (RR = 0.37, 95% CI 0.11-1.24) relative risk reduction with G-CSF, respectively.
  
  
  CONCLUSIONS
  In routine clinical practice, TC and FEC-D without G-CSF are associated with FN rates exceeding the 20% threshold for which primary G-CSF prophylaxis is commonly recommended, and are considerably higher than those reported in pivotal clinical trials.
authors.affiliation: Atlantic Clinical Cancer Research Unit, Dalhousie University, Halifax, Nova Scotia, Canada. tallal.younis@cdha.nshealth.ca
authors.forename: Tallal
authors.initials: T
authors.lastname: Younis
authors.forename: Daniel
authors.initials: D
authors.lastname: Rayson
authors.forename: Kara
authors.initials: K
authors.lastname: Thompson
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage; D005334:Fever / Q000139:chemically induced / Q000517:prevention & control*; D005472:Fluorouracil / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil