Adjuvant docetaxel for high-risk, node-negative breast cancer
Miguel Martín, Miguel A Seguí, Antonio Antón, Amparo Ruiz, Manuel Ramos, Encarna Adrover, Ignacio Aranda, Alvaro Rodríguez-Lescure, Regina Grosse, Lourdes Calvo, Agustí Barnadas, Dolores Isla, Purificación Martinez del Prado, Manuel Ruiz Borrego, Jerzy Zaluski, Angels Arcusa, Montserrat Muñoz, José M López Vega, José R Mel, Blanca Munarriz, Cristina Llorca, Carlos Jara, Emilio Alba, Jesús Florián, Junfang Li, José A López García-Asenjo, Amparo Sáez, María José Rios, Sergio Almenar, Gloria Peiró, Ana Lluch, GEICAM 9805 Investigators, J Alba, V Alberola, S Alonso Hernández, I Alvarez, J C Alvarez Fernández, J Aneiros Cachaza, P Aramburo, E Aranda, M Argüelles Pinto, A Arizcum, A S Artacho, J Autonell, J M Baena, L Capote Armas, E Castellà, J Castellanos, M Constenla, C Crespo, A de la Cruz Mera, P de las Heras, L de Paz, A Fernández Aramburo, R Fernández Martín, M Fernández Morales, P Fernandez Ruiz, J Ferrando Marco, J Ferrer, R M Franquesa, M E Fuentes Vaamonde, M L García, C García Andrade, A García Palomo, J L García Puche, A Gómez Bernal, J González Palacios, M D Guitián Barreiro, A Hens, A Lorenzo, J L Losa García, E Martínez de Dueñas, E Mendoza García, S A Medina, J Miguel, A Modolell, S Morales, M Moros García, A Murias, M Navalón, A Oltra, R Oncins, M J Palomo González, M Pavcovich, A Pelegrí, E A Peña, L Pérez Gallego, F Riu Fernando, R Rodríguez, I Roig, I Ruiz, E Serrano, M Ull, A Velasco, L Vicioso Recio, H Kölbl, M Losch, C Oberhoff, P Koralewski, Miguel Martín, Miguel A Seguí, Antonio Antón, Amparo Ruiz, Manuel Ramos, Encarna Adrover, Ignacio Aranda, Alvaro Rodríguez-Lescure, Regina Grosse, Lourdes Calvo, Agustí Barnadas, Dolores Isla, Purificación Martinez del Prado, Manuel Ruiz Borrego, Jerzy Zaluski, Angels Arcusa, Montserrat Muñoz, José M López Vega, José R Mel, Blanca Munarriz, Cristina Llorca, Carlos Jara, Emilio Alba, Jesús Florián, Junfang Li, José A López García-Asenjo, Amparo Sáez, María José Rios, Sergio Almenar, Gloria Peiró, Ana Lluch, GEICAM 9805 Investigators, J Alba, V Alberola, S Alonso Hernández, I Alvarez, J C Alvarez Fernández, J Aneiros Cachaza, P Aramburo, E Aranda, M Argüelles Pinto, A Arizcum, A S Artacho, J Autonell, J M Baena, L Capote Armas, E Castellà, J Castellanos, M Constenla, C Crespo, A de la Cruz Mera, P de las Heras, L de Paz, A Fernández Aramburo, R Fernández Martín, M Fernández Morales, P Fernandez Ruiz, J Ferrando Marco, J Ferrer, R M Franquesa, M E Fuentes Vaamonde, M L García, C García Andrade, A García Palomo, J L García Puche, A Gómez Bernal, J González Palacios, M D Guitián Barreiro, A Hens, A Lorenzo, J L Losa García, E Martínez de Dueñas, E Mendoza García, S A Medina, J Miguel, A Modolell, S Morales, M Moros García, A Murias, M Navalón, A Oltra, R Oncins, M J Palomo González, M Pavcovich, A Pelegrí, E A Peña, L Pérez Gallego, F Riu Fernando, R Rodríguez, I Roig, I Ruiz, E Serrano, M Ull, A Velasco, L Vicioso Recio, H Kölbl, M Losch, C Oberhoff, P Koralewski
Abstract
Background: A regimen of docetaxel, doxorubicin, and cyclophosphamide (TAC) is superior to a regimen of fluorouracil, doxorubicin, and cyclophosphamide (FAC) when used as adjuvant therapy in women with node-positive breast cancer. The value of taxanes in the treatment of node-negative disease has not been determined.
Methods: We randomly assigned 1060 women with axillary-node-negative breast cancer and at least one high-risk factor for recurrence (according to the 1998 St. Gallen criteria) to treatment with TAC or FAC every 3 weeks for six cycles after surgery. The primary end point was disease-free survival after at least 5 years of follow-up. Secondary end points included overall survival and toxicity.
Results: At a median follow-up of 77 months, the proportion of patients alive and disease-free was higher among the 539 women in the TAC group (87.8%) than among the 521 women in the FAC group (81.8%), representing a 32% reduction in the risk of recurrence with TAC (hazard ratio, 0.68; 95% confidence interval [CI], 0.49 to 0.93; P=0.01 by the log-rank test). This benefit was consistent, regardless of hormone-receptor status, menopausal status, or number of high-risk factors. The difference in survival rates (TAC, 95.2%; FAC, 93.5%) was not significant (hazard ratio, 0.76; 95% CI, 0.45 to 1.26); however, the number of events was small (TAC, 26; FAC, 34). Rates of grade 3 or 4 adverse events were 28.2% with TAC and 17.0% with FAC (P<0.001). Toxicity associated with TAC was diminished when primary prophylaxis with granulocyte colony-stimulating factor was provided.
Conclusions: As compared with adjuvant FAC, adjuvant TAC improved the rate of disease-free survival among women with high-risk, node-negative breast cancer. (Funded by GEICAM and Sanofi-Aventis; ClinicalTrials.gov number, NCT00121992.).
Source: PubMed