Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/749
Título : Randomized phase 3 trial of fluorouracil, epirubicin, and cyclophosphamide alone or followed by Paclitaxel for early breast cancer.
Autor : Martín, Miguel
Rodríguez-Lescure, Álvaro
Ruiz, Amparo
Alba Conejo, Emilio
Calvo, Lourdes
Ruiz-Borrego, Manuel
Muñárriz, Blanca
Rodríguez, César A
Crespo, Carmen
Álava, Enrique de
López García-Asenjo, José Antonio
Guitián, María Dolores
Almenar, Sergio
González-Palacios, Jesús Fernando
Vera, Francisco
Palacios, José
Ramos, Manuel
Gracia Marco, José Manuel
Lluch, Ana
Álvarez, Isabel
Seguí, Miguel Ángel
Mayordomo, José Ignacio
Antón, Antonio
Baena, José Manuel
Plazaola, Arrate
Modolell, Alfonso
Pelegrí, Amadeu
Mel, José Ramón
Aranda, Enrique
Adrover, Encarna
Valero Álvarez, José
García Puche, José Luis
Sánchez-Rovira, Pedro
González, Sonia
López-Vega, José Manuel
Filiación: [Martín,M] Department of Medical Oncology, Hospital Universitario San Carlos, Madrid, Spain. [López García-Asenjo,JA] Department of Pathology, Hospital Universitario San Carlos, Madrid, Spain. [Rodríguez-Lescure,A] Department of Medical Oncology, Hospital Universitario de Elche, Spain. [Ruiz,A] Department of Medical Oncology, Instituto Valenciano de Oncologia, Valencia, Spain. [Almenar,S] Department of Pathology, Instituto Valenciano de Oncologia, Valencia, Spain. [Alba Conejo,E] Department of Medical Oncology, Hospital Virgen de la Victoria, Málaga, Spain. [Calvo,L] Department of Medical Oncology, Complejo Hospitalario Juan Canalejo, La Coruña, Spain. [Guitián,MD] Department of Pathology, Complejo Hospitalario Juan Canalejo, La Coruña, Spain. [Ruiz-Borrego,M] Department of Medical Oncology, Hospital Vírgen del Rocío, Sevilla, Spain [Palacios,J] Department of Pathology, Hospital Vírgen del Rocío, Sevilla, Spain. [Muñárriz,B] Department of Medical Oncology, Hospital La Fe, Valencia, Spain. [Vera,F] Department of Pathology, Hospital La Fe, Valencia, Spain. [Rodríguez, CA] Department of Medical Oncology, Hospital Universitario de Salamanca, Salamanca, Spain. [Crespo,C] Department of Medical Oncology, Hospital Ramón y Cajal, Madrid, Spain. [González-Palacios,JF] Department of Pathology, Hospital Ramón y Cajal, Madrid, Spain. [de Álava,E] Department of Pathology, Centro de Investigación del Cáncer, Salamanca, Spain. [Ramos,M] Department of Medical Oncology, Centro Oncológico de Galicia, La Coruña, Spain. [Gracia Marco,JM] Department of Medical Oncology, Hospital de Cabueñes, Gijón, Spain. [Lluch,A] Department of Medical Oncology, Hospital Clínico Universitario de Valencia, Valencia, Spain. [Álvarez,I] Department of Medical Oncology, Hospital de Donostia, San Sebastián, Spain. [Seguí,MA] Department of Medical Oncology, Hospital Parc Taulí, Sabadell, Spain. [Mayordomo,JI] Department of Medical Oncology, Hospital Clínico Lozano Blesa, Zaragoza, Spain. [Antón,A] Department of Medical Oncology, Hospital Miguel Servet, Zaragoza, Spain. [Baena,JM] Department of Medical Oncology, Complejo Hospitalario Puerta del Mar, Cádiz, Spain. [Plazaola,A] Department of Medical Oncology, Instituto Oncológico de Guipúzcoa, San Sebastián, Spain. [Modolell,A] Department of Medical Oncology, Clínica Corachan, Barcelona, Spain. [Pelegrí,A] Department of Medical Oncology, Hospital Universitario San Joan de Reus, Tarragona, Spain. [Mel,JR] Department of Medical Oncology, Complejo Hospitalario Xeral Calde, Lugo, Spain. [Aranda,E] Department of Medical Oncology, Hospital Provincial de Córdoba, Córdoba, Spain. [Adrover,E] Department of Medical Oncology, Hospital General de Alicante, Alicante, Spain. [Valero Álvarez,J] Hospital Provincial de Zamora, Spain. [García Puche,JL] Department of Medical Oncology, Hospital San Cecilio de Granada, Granada, Spain. [Sánchez-Rovira,P] Department of Medical Oncology, Hospital Ciudad de Jaén, Jaén, Spain. [González,S] Department of Medical Oncology, Mutua de Terrasa, Terrasa, Spain. [López-Vega,JM] Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander, Spain.
Grupo de Investigación: GEICAM 9906 Study Investigators
Palabras clave : ERBB2 protein, human
Anciano
Antineoplásicos Fitogénicos
Protocolos de Quimioterapia Combinada Antineoplásica
Neoplasias de la Mama
Carcinoma Ductal de Mama
Carcinoma Lobular
Ciclofosfamida
Supervivencia sin Enfermedad
Esquema de Medicación
Epirrubicina
Fluorouracilo
Inmunohistoquímica
Hibridación Fluorescente In Situ
Infusiones Intravenosas
Estimación de Kaplan-Meier
Estadificación de Neoplasias
Pronóstico
Modelos de Riesgos Proporcionales
Receptor erbB-2
Receptores Estrogénicos
Receptores de Progesterona
Resultado del Tratamiento
Marcadores Biológicos de Tumor
MeSH: Medical Subject Headings::Named Groups::Persons::Age Groups::Adult::Aged
Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents::Antineoplastic Agents, Phytogenic
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Clinical Protocols::Antineoplastic Protocols::Antineoplastic Combined Chemotherapy Protocols
Medical Subject Headings::Diseases::Neoplasms::Neoplasms by Site::Breast Neoplasms
Medical Subject Headings::Diseases::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Adenocarcinoma::Carcinoma, Ductal::Carcinoma, Ductal, Breast
Medical Subject Headings::Diseases::Neoplasms::Neoplasms by Histologic Type::Neoplasms, Glandular and Epithelial::Carcinoma::Adenocarcinoma::Carcinoma, Lobular
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Hydrocarbons::Hydrocarbons, Halogenated::Mustard Compounds::Nitrogen Mustard Compounds::Phosphoramide Mustards::Cyclophosphamide
Medical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Statistics as Topic::Survival Analysis::Disease-Free Survival
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Administration Schedule
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Hydrocarbons::Hydrocarbons, Cyclic::Hydrocarbons, Aromatic::Polycyclic Hydrocarbons, Aromatic::Naphthacenes::Anthracyclines::Daunorubicin::Doxorubicin::Epirubicin
Medical Subject Headings::Check Tags::Female
Medical Subject Headings::Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Pyrimidines::Pyrimidinones::Uracil::Fluorouracil
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Disciplines and Occupations::Natural Science Disciplines::Biological Science Disciplines::Biochemistry::Immunochemistry
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Cytological Techniques::Histocytological Preparation Techniques::Staining and Labeling::In Situ Hybridization::In Situ Hybridization, Fluorescence
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Administration Routes::Infusions, Parenteral::Infusions, Intravenous
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Survival Analysis::Kaplan-Meier Estimate
Medical Subject Headings::Named Groups::Persons::Age Groups::Adult::Middle Aged
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Neoplasm Staging
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Hydrocarbons::Hydrocarbons, Cyclic::Hydrocarbons, Alicyclic::Cycloparaffins::Cyclodecanes::Taxoids::Paclitaxel
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Models, Theoretical::Models, Statistical::Proportional Hazards Models
Medical Subject Headings::Chemicals and Drugs::Enzymes and Coenzymes::Enzymes::Transferases::Phosphotransferases::Phosphotransferases (Alcohol Group Acceptor)::Protein Kinases::Protein-Tyrosine Kinases::Receptor Protein-Tyrosine Kinases::Receptor, erbB-2
Medical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Receptors, Cytoplasmic and Nuclear::Receptors, Steroid::Receptors, Estrogen
Medical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::DNA-Binding Proteins::Receptors, Cytoplasmic and Nuclear::Receptors, Steroid::Receptors, Progesterone
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome
Medical Subject Headings::Chemicals and Drugs::Biological Factors::Biological Markers::Tumor Markers, Biological
Medical Subject Headings::Named Groups::Persons::Age Groups::Adult
Fecha de publicación : 4-Jun-2008
Editorial : Oxford University Press
Cita Bibliográfica: 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
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.
Descripción : Clinical Trial, Phase III; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;
URI: http://hdl.handle.net/10668/749
Versión del editor : http://jnci.oxfordjournals.org/content/100/11/805.full
DOI: 10.1093/jnci/djn151
ISSN : 1460-2105 (Online)
0027-8874 (Print)
Appears in Collections:01- Artículos - Hospital San Cecilio
01- Artículos - Hospital Virgen de la Victoria
01- Artículos - Complejo Hospitalario de Jaén
01- Artículos - Hospital Virgen del Rocío

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