RT Journal Article
T1 Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by Paclitaxel for early breast cancer.
A1 Martín, Miguel
A1 Rodríguez-Lescure, Álvaro
A1 Ruiz, Amparo
A1 Alba Conejo, Emilio
A1 Calvo, Lourdes
A1 Ruiz-Borrego, Manuel
A1 Muñárriz, Blanca
A1 Rodríguez, César A
A1 Crespo, Carmen
A1 Álava, Enrique de
A1 López García-Asenjo, José Antonio
A1 Guitián, María Dolores
A1 Almenar, Sergio
A1 González-Palacios, Jesús Fernando
A1 Vera, Francisco
A1 Palacios, José
A1 Ramos, Manuel
A1 Gracia Marco, José Manuel
A1 Lluch, Ana
A1 Álvarez, Isabel
A1 Seguí, Miguel Ángel
A1 Mayordomo, José Ignacio
A1 Antón, Antonio
A1 Baena, José Manuel
A1 Plazaola, Arrate
A1 Modolell, Alfonso
A1 Pelegrí, Amadeu
A1 Mel, José Ramón
A1 Aranda, Enrique
A1 Adrover, Encarna
A1 Valero Álvarez, José
A1 García Puche, José Luis
A1 Sánchez-Rovira, Pedro
A1 González, Sonia
A1 López-Vega, José Manuel
K1 ERBB2 protein, human
K1 Anciano
K1 Antineoplásicos Fitogénicos
K1 Protocolos de Quimioterapia Combinada Antineoplásica
K1 Neoplasias de la Mama
K1 Carcinoma Ductal de Mama
K1 Carcinoma Lobular
K1 Ciclofosfamida
K1 Supervivencia sin Enfermedad
K1 Esquema de Medicación
K1 Epirrubicina
K1 Fluorouracilo
K1 Inmunohistoquímica
K1 Hibridación Fluorescente In Situ
K1 Infusiones Intravenosas
K1 Estimación de Kaplan-Meier
K1 Estadificación de Neoplasias
K1 Pronóstico
K1 Modelos de Riesgos Proporcionales
K1 Receptor erbB-2
K1 Receptores Estrogénicos
K1 Receptores de Progesterona
K1 Resultado del Tratamiento
K1 Marcadores Biológicos de Tumor
AB BACKGROUNDTaxanes are among the most active drugs for the treatment of metastatic breast cancer, and, as a consequence, they have also been studied in the adjuvant setting.METHODSAfter breast cancer surgery, women with lymph node-positive disease were randomly assigned to treatment with fluorouracil, epirubicin, and cyclophosphamide (FEC) or with FEC followed by weekly paclitaxel (FEC-P). The primary endpoint of study-5-year disease-free survival (DFS)-was assessed by Kaplan-Meier analysis. Secondary endpoints included overall survival and analysis of the prognostic and predictive value of clinical and molecular (hormone receptors by immunohistochemistry and HER2 by fluorescence in situ hybridization) markers. Associations and interactions were assessed with a multivariable Cox proportional hazards model for DFS for the following covariates: age, menopausal status, tumor size, lymph node status, type of chemotherapy, tumor size, positive lymph nodes, HER2 status, and hormone receptor status. All statistical tests were two-sided.RESULTSAmong the 1246 eligible patients, estimated rates of DFS at 5 years were 78.5% in the FEC-P arm and 72.1% in the FEC arm (difference = 6.4%, 95% confidence interval [CI] = 1.6% to 11.2%; P = .006). FEC-P treatment was associated with a 23% reduction in the risk of relapse compared with FEC treatment (146 relapses in the 614 patients in the FEC-P arm vs 193 relapses in the 632 patients in the FEC arm, hazard ratio [HR] = 0.77, 95% CI = 0.62 to 0.95; P = .022) and a 22% reduction in the risk of death (73 and 95 deaths, respectively, HR = 0.78, 95% CI = 0.57 to 1.06; P = .110). Among the 928 patients for whom tumor samples were centrally analyzed, type of chemotherapy (FEC vs FEC-P) (P = .017), number of involved axillary lymph nodes (P < .001), tumor size (P = .020), hormone receptor status (P = .004), and HER2 status (P = .006) were all associated with DFS. We found no statistically significant interaction between HER2 status and paclitaxel treatment or between hormone receptor status and paclitaxel treatment.CONCLUSIONSAmong patients with operable breast cancer, FEC-P treatment statistically significantly reduced the risk of relapse compared with FEC as adjuvant therapy.
PB Oxford University Press
SN 0027-8874
YR 2008
FD 2008-06-04
LK http://hdl.handle.net/10668/749
UL http://hdl.handle.net/10668/749
LA en
NO Martín M, Rodríguez-Lescure A, Ruiz A, Alba E, Calvo L, Ruiz-Borrego M, et al. Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by Paclitaxel for early breast cancer. J. Natl. Cancer Inst.. 2008                         ; 100(11):805-14
NO Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;
DS RISalud
RD Apr 6, 2025