TY - JOUR
T1 - 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
AU - Martín, Miguel
AU - Simón, Amparo Ruiz
AU - Borrego, Manuel Ruiz
AU - Ribelles, Nuria
AU - Rodríguez-Lescure, Álvaro
AU - Muñoz-Mateu, Montserrat
AU - González, Sonia
AU - Vila, Mireia Margelí
AU - Barnadas, Agustí
AU - Ramos, Manuel
AU - Del Barco Berron, Sonia
AU - Jara, Carlos
AU - Calvo, Lourdes
AU - Martínez-Jáñez, Noelia
AU - Fernández, César Mendiola
AU - Rodríguez, César A.
AU - De Dueñas, Eduardo Martínez
AU - Andrés, Raquel
AU - Plazaola, Arrate
AU - De La Haba-Rodríguez, Juan
AU - López-Vega, Jose Manuel
AU - Adrover, Encarna
AU - Ballesteros, Ana Isabel
AU - Santaballa, Ana
AU - Sánchez-Rovira, Pedro
AU - Baena-Cañada, José M.
AU - Casas, Maribel
AU - Del Carmen Cámara, María
AU - Carrasco, Eva Maria
AU - Lluch, Ana
PY - 2015/11/10
Y1 - 2015/11/10
N2 - © 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.
AB - © 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.
U2 - 10.1200/JCO.2015.61.9510
DO - 10.1200/JCO.2015.61.9510
M3 - Article
SN - 0732-183X
VL - 33
SP - 3788
EP - 3795
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 32
ER -
