Year: 2010
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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: New England Journal of Medicine
Authors: 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
Institution: Hospital General Universitario Gregorio Marañón
Language: English
Subfield: Cancer Research
Domain: Life Sciences
Open Access status: bronze
OpenAlex ID: W2084370697