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Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by Paclitaxel for early breast cancer.
J Natl Cancer Inst. 2008 Jun 04; 100(11):805-14.JNCI

Abstract

BACKGROUND

Taxanes 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.

METHODS

After 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.

RESULTS

Among 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.

CONCLUSIONS

Among patients with operable breast cancer, FEC-P treatment statistically significantly reduced the risk of relapse compared with FEC as adjuvant therapy.

Authors+Show Affiliations

Servicio de Oncologia Medica, Hospital Universitario San Carlos, Ciudad Universitaria s/n, 28040 Madrid, Spain. mmartin@geicam.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18505968

Citation

Martín, Miguel, et al. "Randomized Phase 3 Trial of Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed By Paclitaxel for Early Breast Cancer." Journal of the National Cancer Institute, vol. 100, no. 11, 2008, pp. 805-14.
Martín M, Rodríguez-Lescure A, Ruiz A, 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.
Martín, M., Rodríguez-Lescure, A., Ruiz, A., Alba, E., Calvo, L., Ruiz-Borrego, M., Munárriz, B., Rodríguez, C. A., Crespo, C., de Alava, E., López García-Asenjo, J. A., Guitián, M. D., Almenar, S., González-Palacios, J. F., Vera, F., Palacios, J., Ramos, M., Gracia Marco, J. M., Lluch, A., ... López-Vega, J. M. (2008). Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by Paclitaxel for early breast cancer. Journal of the National Cancer Institute, 100(11), 805-14. https://doi.org/10.1093/jnci/djn151
Martín 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 Jun 4;100(11):805-14. PubMed PMID: 18505968.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by Paclitaxel for early breast cancer. AU - Martín,Miguel, AU - Rodríguez-Lescure,Alvaro, AU - Ruiz,Amparo, AU - Alba,Emilio, AU - Calvo,Lourdes, AU - Ruiz-Borrego,Manuel, AU - Munárriz,Blanca, AU - Rodríguez,César A, AU - Crespo,Carmen, AU - de Alava,Enrique, AU - López García-Asenjo,José Antonio, AU - Guitián,María Dolores, AU - Almenar,Sergio, AU - González-Palacios,Jesús Fernando, AU - Vera,Francisco, AU - Palacios,José, AU - Ramos,Manuel, AU - Gracia Marco,Jose Manuel, AU - Lluch,Ana, AU - Alvarez,Isabel, AU - Seguí,Miguel Angel, AU - Mayordomo,José Ignacio, AU - Antón,Antonio, AU - Baena,José Manuel, AU - Plazaola,Arrate, AU - Modolell,Alfonso, AU - Pelegrí,Amadeu, AU - Mel,Jose Ramón, AU - Aranda,Enrique, AU - Adrover,Encarna, AU - Alvarez,José Valero, AU - García Puche,José Luis, AU - Sánchez-Rovira,Pedro, AU - Gonzalez,Sonia, AU - López-Vega,José Manuel, AU - ,, Y1 - 2008/05/27/ PY - 2008/5/29/pubmed PY - 2008/7/3/medline PY - 2008/5/29/entrez SP - 805 EP - 14 JF - Journal of the National Cancer Institute JO - J Natl Cancer Inst VL - 100 IS - 11 N2 - BACKGROUND: Taxanes 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. METHODS: After 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. RESULTS: Among 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. CONCLUSIONS: Among patients with operable breast cancer, FEC-P treatment statistically significantly reduced the risk of relapse compared with FEC as adjuvant therapy. SN - 1460-2105 UR - https://www.unboundmedicine.com/medline/citation/18505968/Randomized_phase_3_trial_of_fluorouracil_epirubicin_and_cyclophosphamide_alone_or_followed_by_Paclitaxel_for_early_breast_cancer_ L2 - https://academic.oup.com/jnci/article-lookup/doi/10.1093/jnci/djn151 DB - PRIME DP - Unbound Medicine ER -