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