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

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-posit...

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Detalles Bibliográficos
Autores principales: Brain, E, Levy, C, Serin, D, Roché, H, Spielmann, M, Delva, R, Veyret, C, Mauriac, L, Rios, M, Martin, A L, Jimenez, M, Asselain, B, Gauthier, M, Bonnetain, F, Fumoleau, P
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group 2011
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3242527/
https://www.ncbi.nlm.nih.gov/pubmed/22009030
http://dx.doi.org/10.1038/bjc.2011.414
Descripción
Sumario: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.