title: First-line gemcitabine versus epirubicin in postmenopausal women aged 60 or older with metastatic breast cancer: a multicenter, randomized, phase III study.
abstract: BACKGROUND
  This randomized, phase III study compared the efficacy and safety of first-line gemcitabine versus epirubicin in the treatment of postmenopausal women with metastatic breast cancer (MBC).
  
  
  METHODS
  Patients aged > or = 60 years (median 68 years) with clinically measurable MBC received either gemcitabine 1200 mg/m(2) or epirubicin 35 mg/m(2) on days 1, 8, and 15 of a 28-day cycle.
  
  
  RESULTS
  Of 410 patients entered, 397 (198 gemcitabine and 199 epirubicin) were randomized and qualified for the time to progressive disease (TTP) and survival analyses. Total cycles administered in 185 gemcitabine and 192 epirubicin patients, respectively, were 699 (mean 3.5, range 0-12) and 917 (mean 4.6, range 0-10). Epirubicin demonstrated statistically significant superiority in TTP (6.1 and 3.4 months, P=0.0001), overall survival (19.1 and 11.8 months, P=0.0004), and independently assessed response rate (40.3% and 16.4% in 186 and 183 evaluable patients, P <0.001). For gemcitabine (n=190) and epirubicin (n=192), respectively, common WHO grade 3/4 toxicities were neutropenia (25.3% and 17.9%) and leukopenia (14.3% and 19.3%). Of the 28 on-study deaths (17 gemcitabine, 11 epirubicin), three were considered possibly or probably related to treatment (gemcitabine).
  
  
  CONCLUSIONS
  Postmenopausal women > or =60 years of age with MBC tolerate chemotherapy well. In this study, epirubicin was superior to gemcitabine in the treatment of MBC in women age > or =60, confirming that anthracyclines remain important drugs for first-line treatment of MBC.
authors.affiliation: Hospital do Cancer, São Paulo, Brazil. omfeher@terra.com.br
authors.forename: O
authors.initials: O
authors.lastname: Feher
authors.forename: P
authors.initials: P
authors.lastname: Vodvarka
authors.forename: J
authors.initials: J
authors.lastname: Jassem
authors.forename: G
authors.initials: G
authors.lastname: Morack
authors.forename: S H
authors.initials: SH
authors.lastname: Advani
authors.forename: K S
authors.initials: KS
authors.lastname: Khoo
authors.forename: D C
authors.initials: DC
authors.lastname: Doval
authors.forename: S
authors.initials: S
authors.lastname: Ermisch
authors.forename: D
authors.initials: D
authors.lastname: Roychowdhury
authors.forename: M A
authors.initials: MA
authors.lastname: Miller
authors.forename: G
authors.initials: G
authors.lastname: von Minckwitz
mesh_terms: D000368:Aged; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015251:Epirubicin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017698:Postmenopause; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D015251:Epirubicin; D000093542:Gemcitabine