• Miguel Martín, Amparo Ruiz Simón, Manuel Ruiz Borrego, Nuria Ribelles, Álvaro Rodríguez-Lescure, Montserrat Muñoz-Mateu, Sonia González, Mireia Margelí Vila, Agustí Barnadas, Manuel Ramos, Sonia Del Barco Berron, Carlos Jara, Lourdes Calvo, Noelia Martínez-Jáñez, César Mendiola Fernández, César A Rodríguez, Eduardo Martínez de Dueñas, Raquel Andrés, Arrate Plazaola, Juan de la Haba-Rodríguez, Jose Manuel López-Vega, Encarna Adrover, Ana Isabel Ballesteros, Ana Santaballa, Pedro Sánchez-Rovira, José M Baena-Cañada, Maribel Casas, María del Carmen Cámara, Eva Maria Carrasco, and Ana Lluch.
• Miguel Martín, Instituto de Investigación Sanitaria Gregorio Marañón, Universidad Complutense; Carlos Jara, Fundación Hospitalaria de Alcorcón; Noelia Martínez-Jáñez, Hospital Universitario Ramón y Cajal; César Mendiola Fernández, Hospital Universitario; Ana Isabel Ballesteros, Hospital de la Princesa; Maribel Casas, María del Carmen Cámara, and Eva Carrasco, GEICAM Headquarters, Madrid; Amparo Ruiz Simón, Instituto Valenciano de Oncología; Ana Santaballa, Hospital Universitario La Fe; Ana Lluch, Hospital Clínico Universitario de Valencia-INCLIVA-Universidad de Valencia, Valencia; Manuel Ruiz Borrego, Hospital Universitario Virgen del Rocío, Sevilla; Nuria Ribelles, Hospital Universitario Virgen de la Victoria IBIMA, Málaga; Álvaro Rodríguez-Lescure, Hospital General de Elche; Encarna Adrover, Hospital Clínico Universitario de Alicante, Alicante; Montserrat Muñoz-Mateu, Hospital Clinic i Provincial; Sonia González, Hospital Mutua de Terrassa; Mireia Margelí Vila, Hospital Universitario Germans Trias i Pujol; Agustí Barnadas, Universitat Autònoma de Barcelona, Barcelona; Manuel Ramos, Centro Oncológico de Galicia; Lourdes Calvo, Complejo Hospitalario Universitario A Coruña, A Coruã; Sonia Del Barco Berron, Instituto Catalán de Oncología, Girona; César A. Rodríguez, Hospital Universitario de Salamanca, Salamanca, Spain; Eduardo Martínez de Dueñas, Hospital Provincial de Castellón, Castellón; Raquel Andrés, Hospital Universitario Lozano Blesa, Zaragoza; Arrate Plazaola, Onkologikoa, San Sebastián; Juan de la Haba-Rodríguez, Universidad de Córdoba, Córdoba; Jose Manuel López-Vega, Hospital Universitario Marqués de Valdecilla, Santander; Pedro Sánchez-Rovira, Complejo Hospitalario de Jaén, Jaén; and José M. Baena-Cañada, Hospital Universitario Puerta del Mar, Cádiz, Spain. mmartin@geicam.org.
• J. Clin. Oncol. 2015 Nov 10; 33 (32): 3788-95.

PurposeCapecitabine is an active drug in metastatic breast cancer (BC). GEICAM/2003-10 is an adjuvant trial to investigate the integration of capecitabine into a regimen of epirubicin and docetaxel for node-positive early BC.Patients And MethodsPatients with operable node-positive BC (T1-3/N1-3) were eligible. After surgery, 1,384 patients were randomly assigned to receive epirubicin plus cyclophosphamide (EC; 90 and 600 mg/m(2), respectively, × four cycles), followed by docetaxel (100 mg/m(2) × four cycles; EC-T) or epirubicin plus docetaxel (ET; 90 and 75 mg/m(2), respectively, × four cycles), followed by capecitabine (1,250 mg/m(2) twice a day on days 1 to 14, × four cycles; ET-X); all regimens were given every 3 weeks. The primary end point was invasive disease-free survival. Secondary end points included safety (with an alopecia-specific study) and overall survival (OS).ResultsAfter a median follow-up of 6.6 years and 297 events, 86% of patients who received EC-T and 82% of those who received ET-X were invasive disease free at 5 years (hazard ratio, 1.30; 95% CI, 1.03 to 1.64; log-rank P = .03). The OS difference between arms was not statistically significant (hazard ratio, 1.13; 95% CI, 0.82 to 1.55; log-rank P = .46). The most frequent grade 3 to 4 adverse events in the EC-T versus ET-X arms were neutropenia (19% v 10%), with 7% febrile neutropenia across arms; fatigue (13% v 11%); diarrhea (3% v 11%); hand-foot syndrome (2% v 20%); mucositis (6% v 5%); vomiting (both, 5%); and myalgia (4.5% v 1%). Incomplete scalp hair recovery was more frequent in the EC-T than ET-X arm (30% v 14%), and patients who received EC-T wore wigs significantly longer than those who received ET-X (8.35 v 6.03 months).ConclusionInvasive disease-free survival, but not OS, was significantly superior for patients with node-positive early BC who received the adjuvant standard schedule EC-T than for those who received the experimental ET-X regimen. Toxicity profiles differed substantially across arms.© 2015 by American Society of Clinical Oncology.

37 keywords...

hide…