@article{3089613,
    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)",
    author = "Polyzos, A. and Malamos, N. and Boukovinas, I. and Adamou, A. and Ziras, N. and Kalbakis, K. and Kakolyris, S. and Syrigos, K. and Papakotoulas, P. and Kouroussis, C. and Karvounis, N. and Vamvakas, L. and Christophyllakis, C. and Athanasiadis, A. and Varthalitis, I. and Georgoulias, V. and Mavroudis, D.",
    journal = "Breast Cancer Research and Treatment",
    year = "2010",
    volume = "119",
    number = "1",
    pages = "95-104",
    issn = "0167-6806, 1573-7217",
    doi = "10.1007/s10549-009-0468-0",
    keywords = "aromatase inhibitor;  cyclophosphamide;  docetaxel;  epirubicin;  fluorouracil;  recombinant granulocyte colony stimulating factor;  steroid;  tamoxifen;  trastuzumab, adjuvant therapy;  adult;  aged;  alopecia;  anemia;  article;  asthenia;  axillary lymph node;  bone marrow toxicity;  breast cancer;  cancer adjuvant therapy;  cancer combination chemotherapy;  cancer relapse;  cancer research;  cancer size;  cancer staging;  cancer survival;  cardiotoxicity;  chronic kidney failure;  clinical trial;  comparative study;  constipation;  controlled clinical trial;  controlled study;  diarrhea;  disease free survival;  drug dose sequence;  drug efficacy;  drug fatality;  drug tolerability;  drug withdrawal;  early cancer;  febrile neutropenia;  female;  fluid retention;  follow up;  human;  hypersensitivity reaction;  lung embolism;  lymph node metastasis;  lymphoproliferative disease;  major clinical study;  mastectomy;  multicenter study;  multiple cycle treatment;  myelodysplastic syndrome;  nail disease;  nausea;  neurotoxicity;  neutropenia;  overall survival;  phase 3 clinical trial;  priority journal;  randomized controlled trial;  septic shock;  side effect;  stomatitis;  thrombocytopenia;  treatment duration, Adenocarcinoma;  Adult;  Aged;  Antineoplastic Combined Chemotherapy Protocols;  Breast Neoplasms;  Chemotherapy, Adjuvant;  Cyclophosphamide;  Disease-Free Survival;  Epirubicin;  Female;  Fluorouracil;  Humans;  Lymphatic Metastasis;  Middle Aged;  Time Factors;  Treatment Outcome",
    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/m2) followed by 4 cycles of epirubicin (75 mg/m2) plus cyclophosphamide (700 mg/m2) (experimental arm) or 6 cycles of FEC (epirubicin 75 mg/m2, cyclophosphamide 700 mg/m2, and 5-fluorouracil 700 mg/m2; 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. © 2009 Springer Science+Business Media, LLC."
}