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)
Lluch, Ana (GEICAM, Spanish Breast Cancer Group, Madrid, Spain)
Barrios, Carlos H. (LACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil)
Torrecillas, Laura (Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (Mèxic). Centro Médico Nacional 20 de Noviembre)
Ruiz-Borrego, Manuel (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Bines, Jose (Instituto Nacional de Câncer, Rio de Janeiro, Brazil)
Segalla, Jose (Hospital Amaral Carvalho, Sao Paolo, Brazil)
Guerrero-Zotano, Ángel L (Fundació Institut Valencià d'Oncologia)
García-Sáenz, Jose A. (Hospital Clínico San Carlos (Madrid))
Torres, Roberto (Instituto Nacional del Cáncer, Santiago, Chile)
de la Haba Rodríguez, Juan Rafael (Hospital Universitario Reina Sofía (Còrdova, Espanya))
García-Martínez, Elena (Hospital General Universitario Morales Meseguer (Múrcia))
Gómez, Henry L. (GECOPERU, Peruvian Oncological Clinical Studies Group, Lima, Peru)
Llombart, Antonio (Hospital Arnau de Vilanova (Lleida, Catalunya))
Salvador Bofill, Javier (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Baena-Cañada, José M. (Hospital Universitario Puerta del Mar (Cadis, Andalusia))
Barnadas i Molins, Agustí (Institut d'Investigació Biomèdica Sant Pau)
Calvo, L.. (Complejo Hospitalario Universitario de A Coruña)
Pérez-Michel, Laura (Hospital de San José, Ciudad Obregón, Sonora, México)
Ramos, Manuel (Centro Oncológico de Galicia, A Coruña, Spain)
Fernández, Isaura (Complexo Hospitalario Universitario de Vigo)
Rodríguez-Lescure, Álvaro (Hospital General Universitario de Elche)
Cárdenas, Jesús (Centro Médico Colima, Colima, México)
Vinholes, Jeferson (Unidade de Novos Tratamentos CliniOnco, Porto Alegre, Brazil)
Martínez de Dueñas, Eduardo (Consorci Hospitalari Provincial de Castelló)
Godes, Maria J. (Hospital General Universitario de Valencia)
Seguí, Miguel A. (Parc Taulí Hospital Universitari. Institut d'Investigació i Innovació Parc Taulí (I3PT))
Antón, Antonio (Instituto de Investigación Sanitaria de Aragón)
López-Álvarez, Pilar (Hospital Universitario Nuestra Señora de Candelaria (Santa Cruz de Tenerife))
Moncayo, Jorge (Social S Hospital Teodoro Maldonado Carbo, Guayaquil, Ecuador)
Amorim, Gilberto (Oncologistas Associados-Oncologia D'Or, Rio de Janeiro, Brazil)
Villar, Esther (Hospital Regional Universitario de Málaga)
Reyes, Salvador (Hospital Beneficiencia Española, San Luis de Potosí, México)
Sampaio, Carlos (Clínica Amo Itaigara, Salvador, Brazil)
Cardemil, Bernardita (Hospital Base de Valdivia, Valdivia, Chile)
Escudero, Maria J. (GEICAM, Spanish Breast Cancer Group, Madrid, Spain)
Bezares, Susana (GEICAM, Spanish Breast Cancer Group, Madrid, Spain)
Carrasco, Eva (GEICAM, Spanish Breast Cancer Group, Madrid, Spain)
Martín Jiménez, Miguel (Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM))
Universitat Autònoma de Barcelona

Date:	2019
Abstract:	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.
Note:	Altres ajuts: Agustí Barnadas: Honoraria: Pfizer. Consulting or Advisory Role: Pfizer, Novartis, Eli Lilly. Speakers'Bureau: Roche, Pfizer, Novartis, Genomic Health International. Travel, Accommodations, Expenses: Roche, Pfizer; Miguel A. Seguí: Consulting or Advisory Role: Roche, Pfizer, Novartis, Amgen, Eisai, Eli Lilly. Speakers' Bureau: Roche, Pfizer, Amgen. Research Funding: Roche (Inst), Novartis (Inst). Travel, Accommodations, Expenses: Roche, Pfizer, Novartis, Amgen.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	Journal of Clinical Oncology, Vol. 38 (december 2019) , p. 203-213, ISSN 1527-7755

DOI: 10.1200/JCO.19.00904
PMID: 31804894

12 p, 822.4 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Parc Taulí Research and Innovation Institute (I3PT
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
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Articles > Published articles