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)
Lluch, A.; Barrios, C. H.; Torrecillas, L.; Ruiz-Borrego, M.; Bines, J.; Segalla, J.; Guerrero-Zotano, A.; Garcia-Saenz, J. A.; Torres, R.; de la Haba, J.; Garcia-Martinez, E.; Gomez, H. L.; Llombart, A.; Bofill, J. S.; Baena-Canada, J. M.; Barnadas, A.; Calvo Martínez, Lourdes; Perez-Michel, L.; Ramos, M.; Fernández Pérez, Isaura; Rodriguez-Lescure, A.; Cardenas, J.; Vinholes, J.; Martinez de Duenas, E.; Godes, M. J.; Segui, M. A.; Anton, A.; Lopez-Alvarez, P.; Moncayo, J.; Amorim, G.; Villar, E.; Reyes, S.; Sampaio, C.; Cardemil, B.; Escudero, M. J.; Bezares, S.; Carrasco, E.; Martin, M.
![Thumbnail](/xmlui/themes/Mirage2//images/thumbnails/thumn_cientif.png)
Identificadores![](/xmlui/themes/Mirage2//images/despl_identif.png)
Identificadores
URI: http://hdl.handle.net/20.500.11940/16145
PMID: 31804894
DOI: 10.1200/jco.19.00904
ISSN: 0732-183X
Visualización o descarga de ficheros![](/xmlui/themes/Mirage2//images/despl_contenidos.png)
Visualización o descarga de ficheros
Fecha de publicación
2020Título de revista
Journal Of Clinical Oncology
Tipo de contenido
Journal Article
DeCS
supervivencia sin enfermedad | neoplasias de mama triple negativos | anciano | antimetabolitos | adulto joven | mediana edad | humanos | tratamiento neoadyuvante | adultoMeSH
Triple Negative Breast Neoplasms | Antimetabolites | Adult | Neoadjuvant Therapy | Middle Aged | Humans | Disease-Free Survival | Young Adult | AgedResumen
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.
Excepto si se señala otra cosa, la licencia del ítem se describe como Attribution-NonCommercial-NoDerivatives 4.0 International
![](/xmlui/themes/Mirage2//images/final_lines.png)