Open AccessPhase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01)
Author(s) -
Ana Lluch,
Carlos H. Barrios,
Laura Torrecillas,
Manuel RuízBorrego,
José Bines,
J. G. M. Segalla,
Ángel Guerrero-Zotano,
José Ángel García-Sáenz,
Roberto Torres,
Juan de la Haba,
Elena GarcíaMartínez,
Henry Gómez,
Antonio Llombart,
Javier Salvador Bofill,
José Manuel Baena-Cañada,
Agustí Barnadas,
Lourdes Calvo,
Laura María de la Asunción Pérez-Michel,
Manuel Ramos,
I. Fernández,
Álvaro Rodríguez-Lescure,
Jesus S. Cardenas,
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,
Ciboma,
and Lacog
Publication year - 2020
Publication title -
journal of clinical oncology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 10.482
H-Index - 548
eISSN - 1527-7755
pISSN - 0732-183X
DOI - 10.1200/jco.19.00904
Subject(s) - capecitabine , medicine , taxane , breast cancer , oncology , triple negative breast cancer , anthracycline , hazard ratio , chemotherapy , lymph node , adjuvant therapy , cancer , gastroenterology , confidence interval , colorectal cancer
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.