Mostrar el registro sencillo del ítem
Artículo
Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01)
dc.creator | Lluch, Ana | es |
dc.creator | Barrios, Carlos H. | es |
dc.creator | Torrecillas, Laura | es |
dc.creator | Ruiz-Borrego, Manuel | es |
dc.creator | Bines, José | es |
dc.creator | Guerrero-Zotano, Ángel | es |
dc.creator | Salvador Bofill, Francisco Javier | es |
dc.creator | Martín, Miguel | es |
dc.date.accessioned | 2023-04-18T15:34:25Z | |
dc.date.available | 2023-04-18T15:34:25Z | |
dc.date.issued | 2020 | |
dc.identifier.citation | Lluch, A., Barrios, C.H., Torrecillas, L., Ruiz-Borrego, M., Bines, J., Guerrero-Zotano, Á.,...,Martín, M. (2020). Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01). Journal of Clinical Oncology, 38 (3), 203-213. https://doi.org/10.1200/JCO.19.00904. | |
dc.identifier.issn | 0732-183x | es |
dc.identifier.issn | 1527-7755 | es |
dc.identifier.uri | https://hdl.handle.net/11441/144599 | |
dc.description.abstract | PURPOSE Operable triple-negative breast cancers (TNBCs) have a higher risk of relapse than non-TNBCs with standard therapy. The GEICAM/2003-11_CIBOMA/2004-01 trial explored extended adjuvant capecitabine after completion of standard chemotherapy in patients with early TNBC. PATIENTS AND METHODS Eligible patients were those with operable, node-positive—or node negative with tumor 1 cm or greater—TNBC, with prior anthracycline- and/or taxane-containing chemotherapy. After central confirmation of TNBC status by immunohistochemistry, patients were randomly assigned to either capecitabine or observation. Stratification factors included institution, prior taxane-based therapy, involved axillary lymph nodes, and centrally determined phenotype (basal v nonbasal, according to cytokeratins 5/6 and/or epidermal growth factor receptor positivity by immunohistochemistry). The primary objective was to compare disease-free survival (DFS) between both arms. RESULTS Eight hundred seventy-six patients were randomly assigned to capecitabine (n = 448) or observation (n = 428). Median age was 49 years, 55.9% were lymph node negative, 73.9% had a basal phenotype, and 67.5% received previous anthracyclines plus taxanes. Median length of follow-up was 7.3 years. DFS was not significantly prolonged with capecitabine versus observation [hazard ratio (HR), 0.82; 95% CI, 0.63 to 1.06; P = .136]. In a preplanned subgroup analysis, nonbasal patients seemed to derive benefit from the addition of capecitabine with a DFS HR of 0.53 versus 0.94 in those with basal phenotype (interaction test P = .0694) and an HR for overall survival of 0.42 versus 1.23 in basal phenotype (interaction test P = .0052). Tolerance of capecitabine was as expected, with 75.2% of patients completing the planned 8 cycles. CONCLUSION This study failed to show a statistically significant increase in DFS by adding extended capecitabine to standard chemotherapy in patients with early TNBC. In a preplanned subset analysis, patients with nonbasal phenotype seemed to obtain benefit with capecitabine, although this will require additional validation. | es |
dc.format | application/pdf | es |
dc.format.extent | 12 | es |
dc.language.iso | eng | es |
dc.publisher | American Society of Clinical Oncology | es |
dc.relation.ispartof | Journal of Clinical Oncology, 38 (3), 203-213. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Adjuvant Capecitabine | es |
dc.subject | Standard Chemotherapy | es |
dc.subject | Triple-Negative Breast Cancer | es |
dc.subject | Early Breast Cancer | es |
dc.title | Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01) | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | http://doi.org/10.1200/JCO.19.00904 | es |
dc.identifier.doi | 10.1200/JCO.19.00904 | es |
dc.journaltitle | Journal of Clinical Oncology | es |
dc.publication.volumen | 38 | es |
dc.publication.issue | 3 | es |
dc.publication.initialPage | 203 | es |
dc.publication.endPage | 213 | es |