TY - JOUR
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)
AU - GEICAM Spanish Breast Cancer Group, CIBOMA (Iberoamerican Coalition for Research in Breast Oncology), and LACOG (Latin American Cooperative Oncology Group)
AU - Lluch, Ana
AU - Barrios, Carlos H.
AU - Torrecillas, Laura
AU - Ruiz-Borrego, Manuel
AU - Bines, Jose
AU - Segalla, Jose
AU - Guerrero-Zotano, Ángel
AU - García-Saénz, Jose A.
AU - Torres, Roberto
AU - de la Haba, Juan
AU - García-Martínez, Elena
AU - Gómez, Henry L.
AU - Llombart, Antonio
AU - Bofill, Javier Salvador
AU - Baena-Cañada, José M.
AU - Barnadas, Agustí
AU - Calvo, Lourdes
AU - Pérez-Michel, Laura
AU - Ramos, Manuel
AU - Fernańdez, Isaura
AU - Rodríguez-Lescure, Álvaro
AU - Cárdenas, Jesús
AU - Vinholes, Jeferson
AU - de Dueñas, Eduardo Martínez
AU - Godes, Maria J.
AU - Seguí, Miguel A.
AU - Antoń, Antonio
AU - Loṕez-Álvarez, Pilar
AU - Moncayo, Jorge
AU - Amorim, Gilberto
AU - Villar, Esther
AU - Reyes, Salvador
AU - Sampaio, Carlos
AU - Cardemil, Bernardita
AU - Escudero, Maria J.
AU - Bezares, Susana
AU - Carrasco, Eva
AU - Martín, Miguel
N1 - Publisher Copyright:
Copyright © 2023 American Society of Clinical Oncology. All rights reserved.
PY - 2020/1/20
Y1 - 2020/1/20
N2 - 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.
AB - 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.
UR - https://www.scopus.com/pages/publications/85077946722
U2 - 10.1200/JCO.19.00904
DO - 10.1200/JCO.19.00904
M3 - Artículo
C2 - 31804894
AN - SCOPUS:85077946722
SN - 0732-183X
VL - 38
SP - 203
EP - 213
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 3
ER -
SDG 3 Good Health and Well-being