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)
Date Issued
20 January 2020
Access level
open access
Resource Type
conference paper
Author(s)
Lluch A.
Barrios C.H.
Torrecillas L.
Ruiz-Borrego M.
Bines J.
Segalla J.
Guerrero-Zotano Á.
García-Sáenz J.A.
Torres R.
de la Haba J.
García-Martínez E.
Llombart A.
Bofill J.S.
Baena-Cañada J.M.
Barnadas A.
Calvo L.
Pérez-Michel L.
Ramos M.
Fernández I.
Rodríguez-Lescure Á.
Cárdenas J.
Vinholes J.
Martínez de Dueñas E.
Godes M.J.
Seguí M.A.
Antón A.
López-Álvarez P.
Moncayo J.
Amorim G.
Villar E.
Reyes S.
Sampaio C.
Cardemil B.
Escudero M.J.
Bezares S.
Carrasco E.
Martín M.
Publisher(s)
Lippincott Williams and Wilkins
Abstract
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.
Start page
203
End page
213
Volume
38
Issue
3
Language
English
OCDE Knowledge area
Oncología
Patología
Scopus EID
2-s2.0-85077946722
PubMed ID
Source
Journal of clinical oncology : official journal of the American Society of Clinical Oncology
ISSN of the container
0732183X
Sponsor(s)
Written on behalf of GEICAM Spanish Breast Cancer Group, CIBOMA (Iberoamerican Coalition for Research in Breast Oncology), and LACOG (Latin American Cooperative Oncology Group). Funded by F Hoffmann-La Roche. The company also contributed with the study drug (capecitabine; Xeloda), but were not involved in study design, data collection, data analyses or interpretation, or writing of this report.
Sources of information:
Directorio de Producción Científica
Scopus