title: FEC versus sequential docetaxel followed by epirubicin/cyclophosphamide as adjuvant chemotherapy in women with axillary node-positive early breast cancer: a randomized study of the Hellenic Oncology Research Group (HORG).
abstract: A randomized multicenter phase III study was conducted to compare the sequential docetaxel followed by epirubicin/cyclophosphamide combination with that of FEC regimen as adjuvant chemotherapy in women with axillary node-positive early breast cancer. Seven hundred and fifty-six women with axillary lymph node-positive breast cancer were randomized to receive either 4 cycles of docetaxel (100 mg/m(2)) followed by 4 cycles of epirubicin (75 mg/m(2)) plus cyclophosphamide (700 mg/m(2)) (experimental arm) or 6 cycles of FEC (epirubicin 75 mg/m(2), cyclophosphamide 700 mg/m(2), and 5-fluorouracil 700 mg/m(2); control arm). All regimes were administered every 3 weeks. The primary end point was five-year disease-free survival (DFS). After a median follow-up period of 5 years, 233 (30.8%) relapses had occurred (108 and 125 in the experimental and control arms, respectively; P = 0.181). The five-year DFS was 72.6% (95% CI 63.8-81.3%) and 67.2% (95% CI 58.0-76.4%) for women randomized in the experimental and control arms, respectively (P = 0.041; log rank test). There was no difference in the overall survival between the two arms (83.8 and 81.4% in the experimental and control arms, respectively; P = 0.533). The experimental arm was associated with increased neutropenia requiring administration of granulocyte colony-stimulating factor in 90.5% of the patients as compared with 74.1% in the control arm (P = 0.0001). The sequential docetaxel followed by epirubicin/cyclophosphamide adjuvant chemotherapy regimen resulted in improved five-year DFS in women with axillary node-positive early breast cancer at the expense of increased but manageable myelotoxicity.
authors.affiliation: Medical Oncology Unit, 1st Propedeutic Clinic, University School of Medicine, Laiko General Hospital of Athens, Athens, Greece.
authors.forename: Aristides
authors.initials: A
authors.lastname: Polyzos
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Malamos
authors.forename: Ioannis
authors.initials: I
authors.lastname: Boukovinas
authors.forename: Adamos
authors.initials: A
authors.lastname: Adamou
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Ziras
authors.forename: Kostas
authors.initials: K
authors.lastname: Kalbakis
authors.forename: Stylianos
authors.initials: S
authors.lastname: Kakolyris
authors.forename: Kostas
authors.initials: K
authors.lastname: Syrigos
authors.forename: Pavlos
authors.initials: P
authors.lastname: Papakotoulas
authors.forename: Charalambos
authors.initials: C
authors.lastname: Kouroussis
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Karvounis
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Charalambos
authors.initials: C
authors.lastname: Christophyllakis
authors.forename: Athanasios
authors.initials: A
authors.lastname: Athanasiadis
authors.forename: Ioannis
authors.initials: I
authors.lastname: Varthalitis
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
authors.forename: Dimitris
authors.initials: D
authors.lastname: Mavroudis
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism; D017024:Chemotherapy, Adjuvant / Q000379:methods*; D003520:Cyclophosphamide / Q000008:administration & dosage* / Q000627:therapeutic use; D018572:Disease-Free Survival; D015251:Epirubicin / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil