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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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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
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author 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
author_facet 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
author_sort Kerbrat, P
collection PubMed
description 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.
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spelling pubmed-23599102009-09-10 Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial 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 Br J Cancer Clinical Study 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. Nature Publishing Group 2007-06-04 2007-05-15 /pmc/articles/PMC2359910/ /pubmed/17505516 http://dx.doi.org/10.1038/sj.bjc.6603773 Text en Copyright © 2007 Cancer Research UK https://creativecommons.org/licenses/by/4.0/This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material.If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/.
spellingShingle Clinical Study
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
Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial
title Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial
title_full Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial
title_fullStr Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial
title_full_unstemmed Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial
title_short Epirubicin–vinorelbine vs FEC100 for node-positive, early breast cancer: French Adjuvant Study Group 09 trial
title_sort epirubicin–vinorelbine vs fec100 for node-positive, early breast cancer: french adjuvant study group 09 trial
topic Clinical Study
url 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
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