Produção Nacional
Revisado por pares
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)
2019; Lippincott Williams & Wilkins; Volume: 38; Issue: 3 Linguagem: Inglês
10.1200/jco.19.00904
ISSN1527-7755
AutoresAña Lluch, Carlos H. Barrios, Laura Torrecillas, Manuel Ruíz‐Borrego, José Bines, J. G. M. Segalla, Ángel Guerrero‐Zotano, José Á. García-Sáenz, Roberto Torres, Juan de la Haba-Rodríguez, Elena García‐Martínez, Henry Gómez, Antonio Llombart‐Cussac, Javier Salvador Bofill, José Manuel Baena-Cañada, Agustí Barnadas, Lourdes Calvo, Laura María de la Asunción Pérez-Michel, Manuel Ramos, Isaura Fernández, Álvaro Rodríguez-Lescure, Jesús Cárdenas, J. Vinholes, Eduardo Martínez de Dueñas, María José Godes, Miguel Ángel Seguí, Antonio Antón, Pilar López-Álvarez, Jorge Moncayo, Gilberto Amorim, Esther Villar, Salvador Fonseca Reyes, Carlos Eduardo Peres Sampaio, B Cardemil, M.J. Escudero, Susana Bezares, Eva Carrasco, Miguel Martín,
Tópico(s)Advanced Breast Cancer Therapies
ResumoOperable 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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