RT Journal Article
T1 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).
A1 Lluch, Ana
A1 Barrios, Carlos H
A1 Torrecillas, Laura
A1 Ruiz-Borrego, Manuel
A1 Bines, Jose
A1 Segalla, Jose
A1 Guerrero-Zotano, Ángel
A1 García-Sáenz, Jose A
A1 Torres, Roberto
A1 de la Haba, Juan
A1 García-Martínez, Elena
A1 Gómez, Henry L
A1 Llombart, Antonio
A1 Bofill, Javier Salvador
A1 Baena-Cañada, José M
A1 Barnadas, Agustí
A1 Calvo, Lourdes
A1 Pérez-Michel, Laura
A1 Ramos, Manuel
A1 Fernández, Isaura
A1 Rodríguez-Lescure, Álvaro
A1 Cárdenas, Jesús
A1 Vinholes, Jeferson
A1 Martínez de Dueñas, Eduardo
A1 Godes, Maria J
A1 Seguí, Miguel A
A1 Antón, Antonio
A1 López-Álvarez, Pilar
A1 Moncayo, Jorge
A1 Amorim, Gilberto
A1 Villar, Esther
A1 Reyes, Salvador
A1 Sampaio, Carlos
A1 Cardemil, Bernardita
A1 Escudero, Maria J
A1 Bezares, Susana
A1 Carrasco, Eva
A1 Martín, Miguel
A1 GEICAM Spanish Breast Cancer Group, 
A1 CIBOMA (Iberoamerican Coalition for Research in Breast Oncology), 
A1 LACOG (Latin American Cooperative Oncology Group), 
AB 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.
YR 2019
FD 2019-12-05
LK http://hdl.handle.net/10668/14792
UL http://hdl.handle.net/10668/14792
LA en
DS RISalud
RD Apr 11, 2025