High rate of extra-haematological toxicity compromises dose-dense sequential adjuvant chemotherapy for breast cancer View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2011-11

AUTHORS

E Brain, C Levy, D Serin, H Roché, M Spielmann, R Delva, C Veyret, L Mauriac, M Rios, A L Martin, M Jimenez, B Asselain, M Gauthier, F Bonnetain, P Fumoleau

ABSTRACT

BACKGROUND: A dose-dense strategy has been considered to improve results of adjuvant chemotherapy for breast cancer. This randomised phase II trial investigated the feasibility of this approach with sequential anthracyclines and taxanes-based chemotherapy. METHODS: Patients with high-risk node-positive breast cancer were treated with three cycles of fluorouracil 500 mg m(-2), epirubicin 100 mg m(-2), cyclophosphamide 500 mg m(-2) (FEC 100) followed by three cycles of docetaxel 100 mg m(-2) delivered at 2-weekly intervals supported by primary prophylaxis with filgrastim. All patients were randomised to either uninterrupted treatment (arm A) or to have a 2-week additional period of rest between the FEC and docetaxel (arm B). The primary endpoint was the rate of success of chemotherapy delivery. Using a two-stage Fleming design, 120 patients were required with one interim analysis. RESULTS: In March 2005, enrolment was stopped into arm A after the observation of severe skin toxicities. Following the planned interim analysis, the study was closed because of the high rate of grade 3/4 skin toxicities in both arms (arm A: 32.4% and arm B: 18.9%). CONCLUSION: Sequential dose-dense FEC 100 followed by docetaxel 100 mg m(-2) is not feasible. Feasibility still depends largely on several factors including the choice of drugs, dosage and sequence of administration. More... »

PAGES

1480

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/bjc.2011.414

DOI

http://dx.doi.org/10.1038/bjc.2011.414

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1019248622

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/22009030


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312 https://www.grid.ac/institutes/grid.482015.a schema:alternateName Institut Sainte Catherine
313 schema:name Breast Oncology Unit, Institut Sainte-Catherine, 1750 Chemin du Lavarin, 84000 Avignon, France
314 rdf:type schema:Organization
 




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