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).
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.
Polyzos
Aristides
A
Medical Oncology Unit, 1st Propedeutic Clinic, University School of Medicine, Laiko General Hospital of Athens, Athens, Greece.
Malamos
Nikolaos
N
Boukovinas
Ioannis
I
Adamou
Adamos
A
Ziras
Nikolaos
N
Kalbakis
Kostas
K
Kakolyris
Stylianos
S
Syrigos
Kostas
K
Papakotoulas
Pavlos
P
Kouroussis
Charalambos
C
Karvounis
Nikolaos
N
Vamvakas
Lambros
L
Christophyllakis
Charalambos
C
Athanasiadis
Athanasios
A
Varthalitis
Ioannis
I
Georgoulias
Vassilis
V
Mavroudis
Dimitris
D
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
D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil