Epirubicin plus cyclophosphamide followed by docetaxel versus epirubicin plus docetaxel followed by capecitabine as adjuvant therapy for node-positive early breast cancer: Results from the GEICAM/2003-10 study

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-RodríguezJose 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, Ana Lluch

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Abstract

© 2015 by American Society of Clinical Oncology. Purpose: Capecitabine 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 Methods: Patients 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/m2, respectively, × four cycles), followed by docetaxel (100 mg/m2 × four cycles; EC-T) or epirubicin plus docetaxel (ET; 90 and 75 mg/m2, respectively, × four cycles), followed by capecitabine (1,250 mg/m2 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). Results: After 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). Conclusion: Invasive disease-free survival, but not OS, was significantly superior for patients with nodepositive 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.
Original languageEnglish
Pages (from-to)3788-3795
JournalJournal of Clinical Oncology
Volume33
Issue number32
DOIs
Publication statusPublished - 10 Nov 2015

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