| Title: | 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) |
|---|---|
| Author: | Lluch, Ana; Barrios, Carlos H.; Torrecillas, Laura; Ruiz-Borrego, Manuel; Bines, Jose; Segalla, Jose; Guerrero-Zotano, Ángel; García-Sáenz, Jose A.; Torres, Roberto; de la Haba, Juan; García-Martínez, Elena; Gómez, Henry L.; Llombart, Antonio; Bofill, Javier Salvador; Baena-Cañada, José M.; Barnadas i Molins, Agustí; Calvo, Lourdes; Pérez-Michel, Laura; Ramos, Manuel; Fernández, Isaura; Rodríguez-Lescure, Álvaro; Cárdenas, Jesús; Vinholes, Jeferson; Martínez de Dueñas, Eduardo; Godes, Maria J.; Seguí, Miguel A.; Antón, Antonio; López-Álvarez, Pilar; Moncayo, Jorge; Amorim, Gilberto; Villar, Esther; Reyes, Salvador; Sampaio, Carlos; Cardemil, Bernardita; Escudero, Maria J.; Bezares, Susana; Carrasco, Eva; Martín, Miguel; Universitat Autònoma de Barcelona |
| Abstract: | 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. |
| 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. |
| Publication date: | 2021-09-15 |
| Rights: | open access
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. https://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Document type: | Article |
| Published by: | |
| Share: |
|
| Uri: | https://ddd.uab.cat/record/235973 |