dc.contributor.author |
Lluch, Ana |
dc.contributor.author |
Barrios, Carlos H. |
dc.contributor.author |
Torrecillas, Laura |
dc.contributor.author |
Ruiz-Borrego, Manuel |
dc.contributor.author |
Bines, Jose |
dc.contributor.author |
Segalla, Jose |
dc.contributor.author |
Guerrero-Zotano, Ángel |
dc.contributor.author |
García-Sáenz, Jose A. |
dc.contributor.author |
Torres, Roberto |
dc.contributor.author |
de la Haba, Juan |
dc.contributor.author |
García-Martínez, Elena |
dc.contributor.author |
Gómez, Henry L. |
dc.contributor.author |
Llombart, Antonio |
dc.contributor.author |
Bofill, Javier Salvador |
dc.contributor.author |
Baena-Cañada, José M. |
dc.contributor.author |
Barnadas i Molins, Agustí |
dc.contributor.author |
Calvo, Lourdes |
dc.contributor.author |
Pérez-Michel, Laura |
dc.contributor.author |
Ramos, Manuel |
dc.contributor.author |
Fernández, Isaura |
dc.contributor.author |
Rodríguez-Lescure, Álvaro |
dc.contributor.author |
Cárdenas, Jesús |
dc.contributor.author |
Vinholes, Jeferson |
dc.contributor.author |
Martínez de Dueñas, Eduardo |
dc.contributor.author |
Godes, Maria J. |
dc.contributor.author |
Seguí, Miguel A. |
dc.contributor.author |
Antón, Antonio |
dc.contributor.author |
López-Álvarez, Pilar |
dc.contributor.author |
Moncayo, Jorge |
dc.contributor.author |
Amorim, Gilberto |
dc.contributor.author |
Villar, Esther |
dc.contributor.author |
Reyes, Salvador |
dc.contributor.author |
Sampaio, Carlos |
dc.contributor.author |
Cardemil, Bernardita |
dc.contributor.author |
Escudero, Maria J. |
dc.contributor.author |
Bezares, Susana |
dc.contributor.author |
Carrasco, Eva |
dc.contributor.author |
Martín, Miguel |
dc.contributor.author |
Universitat Autònoma de Barcelona |
dc.date |
2019 |
dc.date.accessioned |
2021-09-15T05:08:34Z |
dc.date.available |
2021-09-15T05:08:34Z |
dc.date.issued |
2021-09-15 |
dc.identifier |
https://ddd.uab.cat/record/235973 |
dc.identifier |
10.1200/JCO.19.00904 |
dc.identifier |
oai:ddd.uab.cat:235973 |
dc.identifier |
PMC6968797 |
dc.identifier |
6968797 |
dc.identifier |
31804894 |
dc.identifier |
15277755v38np203 |
dc.identifier.uri |
http://hdl.handle.net/2072/509052 |
dc.format |
application/pdf |
dc.language |
eng |
dc.publisher |
|
dc.relation |
Journal of Clinical Oncology ; Vol. 38 (december 2019), p. 203-213 |
dc.rights |
open access |
dc.rights |
Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades. |
dc.rights |
https://creativecommons.org/licenses/by-nc-nd/4.0/ |
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) |
dc.type |
Article |
dc.description.abstract |
Altres ajuts: Agustí Barnadas: Honoraria: Pfizer. Consulting or Advisory Role: Pfizer, Novartis, Eli Lilly. Speakers'Bureau: Roche, Pfizer, Novartis, Genomic Health International. Travel, Accommodations, Expenses: Roche, Pfizer; Miguel A. Seguí: Consulting or Advisory Role: Roche, Pfizer, Novartis, Amgen, Eisai, Eli Lilly. Speakers' Bureau: Roche, Pfizer, Amgen. Research Funding: Roche (Inst), Novartis (Inst). Travel, Accommodations, Expenses: Roche, Pfizer, Novartis, Amgen. |
dc.description.abstract |
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. 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. 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. 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. |