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Adjuvant Docetaxel for High-Risk, Node-Negative Breast Cancer

2010; Massachusetts Medical Society; Volume: 363; Issue: 23 Linguagem: Inglês

10.1056/nejmoa0910320

1533-4406

Miguel Martín, Miguel Àngel Seguí, Antonio Antón, Amparo Ruı́z, Manuel Ramos, Encarna Adrover, Ignacio Aranda, Álvaro Rodríguez-Lescure, Regina Große, Lourdes Calvo, Agustí Barnadas, Dolores Isla, P. Martínez Del Prado, Manuel Ruíz Borrego, J. Załuski, Àngels Arcusa, Montserrat Muñoz, José Manuel López Vega, J. R. Mel, Blanca Munárriz, Cristina Llorca, Carlos Jara, Emilio Alba, Jesús Florián, Junfang Li, José Antonio López García‐Asenjo, Amparo Sáez, María Rios, Sergio Almenar, Gloria Peiró, Aña Lluch,

Breast Lesions and Carcinomas

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.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.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.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.).