title: Gemcitabine, epirubicin, and paclitaxel versus fluorouracil, epirubicin, and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: a Central European Cooperative Oncology Group International, multicenter, prospective, randomized phase III trial.
abstract: BACKGROUND
  The objectives of this phase III trial were to compare the time to progressive disease (TtPD), overall response rate (ORR), overall survival, and toxicity of gemcitabine, epirubicin, and paclitaxel (GET) versus fluorouracil (FU), epirubicin, and cyclophosphamide (FEC) as first-line therapy in patients with metastatic breast cancer (MBC).
  
  
  METHODS
  Female patients aged 18 to 75 years with stage IV and measurable MBC were enrolled and randomly assigned to either gemcitabine (1,000 mg/m(2), days 1 and 4), epirubicin (90 mg/m(2), day 1), and paclitaxel (175 mg/m(2), day 1) or FU (500 mg/m(2), day 1), epirubicin (90 mg/m(2), day 1), and cyclophosphamide (500 mg/m(2), day 1). Both regimens were administered every 21 days for a maximum of eight cycles.
  
  
  RESULTS
  Between October 1999 and November 2002, 259 patients (GET, n = 124; FEC, n = 135) were enrolled. Baseline characteristics were well balanced across treatment arms. After a median of 20.4 months of follow-up, median TtPD was 9.1 months and 9.0 months in the GET and FEC arms, respectively (P = .557). The ORR was 62.3% in the GET arm (n = 114) and 51.2% in the FEC arm (n = 129; P = .093). Grade 3 and 4 toxicities, including neutropenia, thrombocytopenia, anemia, stomatitis, neurosensory toxicity, and allergy, occurred significantly more often in the GET arm.
  
  
  CONCLUSIONS
  No significant differences in terms of TtPD and ORR were observed between the two treatment arms. Treatment-related toxicity was higher in the GET arm.
authors.affiliation: Department of Medicine I, University Hospital, 18-20 Waehringer Guertel, A-1090 Vienna, Austria. christoph.zielinski@meduniwien.ac.at
authors.forename: Christoph
authors.initials: C
authors.lastname: Zielinski
authors.forename: Semir
authors.initials: S
authors.lastname: Beslija
authors.forename: Zrinka
authors.initials: Z
authors.lastname: Mrsic-Krmpotic
authors.forename: Marzena
authors.initials: M
authors.lastname: Welnicka-Jaskiewicz
authors.forename: Christoph
authors.initials: C
authors.lastname: Wiltschke
authors.forename: Zsuzsanna
authors.initials: Z
authors.lastname: Kahan
authors.forename: Mislav
authors.initials: M
authors.lastname: Grgic
authors.forename: Valentina
authors.initials: V
authors.lastname: Tzekova
authors.forename: Moshe
authors.initials: M
authors.lastname: Inbar
authors.forename: Jozika
authors.initials: J
authors.lastname: Cervek
authors.forename: Ivan
authors.initials: I
authors.lastname: Chernozemsky
authors.forename: Janos
authors.initials: J
authors.lastname: Szanto
authors.forename: Stanislav
authors.initials: S
authors.lastname: Spanik
authors.forename: Maria
authors.initials: M
authors.lastname: Wagnerova
authors.forename: Nicolae
authors.initials: N
authors.lastname: Ghilezan
authors.forename: Janusz
authors.initials: J
authors.lastname: Pawlega
authors.forename: Damir
authors.initials: D
authors.lastname: Vrbanec
authors.forename: Dmitry
authors.initials: D
authors.lastname: Khamtsov
authors.forename: Victoria
authors.initials: V
authors.lastname: Soldatenkova
authors.forename: Thomas
authors.initials: T
authors.lastname: Brodowicz
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use* / Q000633:toxicity; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003520:Cyclophosphamide / Q000627:therapeutic use* / Q000633:toxicity; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use* / Q000633:toxicity; D015251:Epirubicin / Q000627:therapeutic use* / Q000633:toxicity; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use* / Q000633:toxicity; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D043823:Taxoids / Q000627:therapeutic use* / Q000633:toxicity
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D015251:Epirubicin; D003520:Cyclophosphamide; D017239:Paclitaxel; D005472:Fluorouracil