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Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial

The aim of the study was to compare our reference adjuvant chemotherapy, FEC100 (fluorouracil 500 mg m(−2), epirubicin 100 mg m(−2) and cyclophosphamide 500 mg m(−2), six cycles every 21 days), to an epirubicin–vinorelbine (Epi-Vnr) combination for early, poor-prognosis breast cancer patients. Patie...

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Detalles Bibliográficos
Autores principales: Kerbrat, P, Roché, H, Bonneterre, J, Veyret, C, Lortholary, A, Monnier, A, Fumoleau, P, Fargeot, P, Namer, M, Chollet, P, Goudier, M-J, Audhuy, B, Simon, H, Montcuquet, P, Eymard, J-C, Walter, S, Clavère, P, Guastalla, J-P
Formato: Texto
Lenguaje:English
Publicado: Nature Publishing Group 2007
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2359910/
https://www.ncbi.nlm.nih.gov/pubmed/17505516
http://dx.doi.org/10.1038/sj.bjc.6603773
Descripción
Sumario:The aim of the study was to compare our reference adjuvant chemotherapy, FEC100 (fluorouracil 500 mg m(−2), epirubicin 100 mg m(−2) and cyclophosphamide 500 mg m(−2), six cycles every 21 days), to an epirubicin–vinorelbine (Epi-Vnr) combination for early, poor-prognosis breast cancer patients. Patients (482) were randomised to receive FEC100, or Epi-Vnr (epirubicin 50 mg m(−2) day 1 and vinorelbine 25 mg m(−2), days 1 and 8, six cycles every 21 days). The 7-year disease-free survival rates were 59.4 and 58.8%, respectively (P=0.47). The relative dose intensity of planned epirubicin doses was 89.1% with FEC100 and 88.9% with Epi-Vnr. There were significantly more grades 3–4 neutropenia (P=0.009) with Epi-Vnr, and significantly more nausea-vomiting (P<0.0001), stomatitis (P=0.0007) and alopecia (P<0.0001) with FEC100. No cases of congestive heart failure were reported, whereas four decreases in left ventricular ejection fraction occurred after FEC100 and five after Epi-Vnr. One case of acute myeloblastic leukaemia was registered in the FEC100 arm. After 7 years of follow-up, there was no difference between treatment arms. Epi-Vnr regimen provided a good efficacy in such poor-prognosis breast cancer patients, and could be an alternative to FEC100, taking into account respective safety profiles of both regimens.