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 Ana123,Barrios Carlos H.45,Torrecillas Laura6,Ruiz-Borrego Manuel37,Bines Jose58,Segalla Jose59,Guerrero-Zotano Ángel310,García-Sáenz Jose A.311,Torres Roberto12,de la Haba Juan2313,García-Martínez Elena314,Gómez Henry L.1516,Llombart Antonio317,Bofill Javier Salvador318,Baena-Cañada José M.319,Barnadas Agustí2320,Calvo Lourdes321,Pérez-Michel Laura22,Ramos Manuel323,Fernández Isaura324,Rodríguez-Lescure Álvaro325,Cárdenas Jesús26,Vinholes Jeferson527,Martínez de Dueñas Eduardo328,Godes Maria J.329,Seguí Miguel A.330,Antón Antonio331,López-Álvarez Pilar332,Moncayo Jorge33,Amorim Gilberto534,Villar Esther335,Reyes Salvador36,Sampaio Carlos537,Cardemil Bernardita38,Escudero Maria J.3,Bezares Susana3,Carrasco Eva3,Martín Miguel2339, , ,

Affiliation:

1. Hospital Clínico Universitario de Valencia and Biomedical Research Institute INCLIVA, University of Valencia, Valencia, Spain

2. Centro de Investigación Biomédica en Red de Oncología ISCIII, Madrid, Spain

3. GEICAM, Spanish Breast Cancer Group, Madrid, Spain

4. Centro de Pesquisa Clínica Hospital São Lucas da PUCRS, Porto Alegre, Brazil

5. LACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil

6. Centro Médico Nacional 20 de Noviembre, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Ciudad de México, México

7. Hospital Universitario Virgen del Rocío, Sevilla, Spain

8. Instituto Nacional de Câncer, Rio de Janeiro, Brazil

9. Hospital Amaral Carvalho, Sao Paolo, Brazil

10. Instituto Valenciano de Oncología, Valencia, Spain

11. Hospital Clínico San Carlos, Madrid, Spain

12. Instituto Nacional del Cáncer, Santiago, Chile

13. Hospital Universitario Reina Sofía, Córdoba, Spain

14. Hospital General Universitario Morales Meseguer, Murcia, Spain

15. Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú

16. GECOPERU, Peruvian Oncological Clinical Studies Group, Lima, Peru

17. Hospital Arnau de Vilanova, Lleida, Spain

18. Hospital Universitario Na Sa de Valme, Sevilla, Spain

19. Hospital Universitario Puerta del Mar and Instituto de Investigación e Innovación Biomédica de Cádiz, Cádiz, Spain

20. Hospital de la Santa Creu i Sant Pau, Medicine Department Universitat Autonoma, Institut Recerca Biomedica Sant Pau, Barcelona, Spain

21. Complexo Hospitalario Universitario A Coruña, A Coruña, Spain

22. Hospital de San José, Ciudad Obregón, Sonora, México

23. Centro Oncológico de Galicia, A Coruña, Spain

24. Complexo Hospitalario Universitario de Vigo, Vigo, Spain

25. Hospital General Universitario de Elche, Alicante, Spain

26. Centro Médico Colima, Colima, México

27. Unidade de Novos Tratamentos CliniOnco, Porto Alegre, Brazil

28. Consorcio Hospitalario Provincial de Castellón, Castellón, Spain

29. Hospital General Universitario de Valencia, Valencia, Spain

30. Corporació Sanitaria Parc Taulí de Sabadell, Barcelona, Spain

31. Instituto de Investigación Sanitaria Aragon, Hospital Universitario Miguel Servet, Zaragoza, Spain

32. Hospital Nuestra Señora de la Candelaria, Santa Cruz de Tenerife, Spain

33. Social S Hospital Teodoro Maldonado Carbo, Guayaquil, Ecuador

34. Oncologistas Associados–Oncologia D’Or, Rio de Janeiro, Brazil

35. Hospital Regional Universitario Carlos Haya, Málaga, Spain

36. Hospital Beneficiencia Española, San Luis de Potosí, México

37. Clínica Amo Itaigara, Salvador, Brazil

38. Hospital Base de Valdivia, Valdivia, Chile

39. Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense, Madrid, Spain

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.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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