Τίτλος:
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)
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
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.
Συγγραφείς:
Polyzos, A.
Malamos, N.
Boukovinas, I.
Adamou, A.
Ziras, N.
Kalbakis, K.
Kakolyris, S.
Syrigos, K.
Papakotoulas, P.
Kouroussis, C.
Karvounis, N.
Vamvakas, L.
Christophyllakis, C.
Athanasiadis, A.
Varthalitis, I.
Georgoulias, V.
Mavroudis, D.
Περιοδικό:
Breast Cancer Research and Treatment
Λέξεις-κλειδιά:
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
DOI:
10.1007/s10549-009-0468-0
