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)

• Published in: Breast cancer research and treatment 2010-01, Vol.119 (1), p.95-104
• Main Authors: Polyzos, Aristides, Malamos, Nikolaos, Boukovinas, Ioannis, Adamou, Adamos, Ziras, Nikolaos, Kalbakis, Kostas, Kakolyris, Stylianos, Syrigos, Kostas, Papakotoulas, Pavlos, Kouroussis, Charalambos, Karvounis, Nikolaos, Vamvakas, Lambros, Christophyllakis, Charalambos, Athanasiadis, Athanasios, Varthalitis, Ioannis, Georgoulias, Vassilis, Mavroudis, Dimitris
• Format: Article
• Language: English
• Subjects: Adenocarcinoma - drug therapy; Adjuvant treatment; Adult; Aged; Anthracyclines; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - metabolism; Cancer; Cancer research; Cancer therapies; Chemotherapy; Chemotherapy, Adjuvant - methods; Clinical Trial; Clinical trials; Cyclophosphamide; Cyclophosphamide - administration & dosage; Cyclophosphamide - therapeutic use; Disease-Free Survival; Epirubicin - administration & dosage; Epirubicin - therapeutic use; Female; Fluorouracil; Fluorouracil - therapeutic use; Gynecology. Andrology. Obstetrics; Humans; Lymphatic Metastasis; Lymphatic system; Mammary gland diseases; Medical sciences; Medicine; Medicine & Public Health; Middle Aged; Oncology; Oncology, Experimental; Time Factors; Treatment Outcome; Tumors; Women
• ISSN: 0167-6806; 1573-7217
• DOI: 10.1007/s10549-009-0468-0

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.