Adjuvant docetaxel for high-risk, node-negative breast cancer

Martin, M. ; Segui, M. A. ; Anton, A. (Universidad de Zaragoza) ; Ruiz, A. ; Ramos, M. ; Adrover, E. ; Aranda, I. ; Rodriguez-Lescure, A. ; Grosse, R. ; Calvo, L. ; Barnadas, A. ; Isla, D. ; Martinez Del Prado, P. ; Borrego, M. R. ; Zaluski, J. ; Arcusa, A. ; Munoz, M. ; Lopez Vega, J. M. ; Mel, J. R. ; Munarriz, B. ; Llorca, C. ; Jara, C. ; Alba, E. ; Florian, J. ; Li, J. ; Lopez Garcia-Asenjo, J.

Resumen: 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

Idioma: Inglés

Año: 2010

Publicado en: NEW ENGLAND JOURNAL OF MEDICINE 363, 23 (2010), 2200-2210
ISSN: 0028-4793

Factor impacto JCR: 53.486 (2010)

Categ. JCR: MEDICINE, GENERAL & INTERNAL rank: 1 / 152 = 0.007 (2010) - Q1 - T1

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)