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Adjuvant Docetaxel for High-Risk, Node-Negative Breast Cancer
- Source :
- NEW ENGLAND JOURNAL OF MEDICINE, r-FISABIO. Repositorio Institucional de Producción Científica, instname, r-FISABIO: Repositorio Institucional de Producción Científica, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
- Publication Year :
- 2010
- Publisher :
- MASSACHUSETTS MEDICAL SOC, 2010.
-
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
- Subjects :
- Adult
Oncology
medicine.medical_specialty
Receptor, ErbB-2
Breast Neoplasms
Docetaxel
Kaplan-Meier Estimate
Young Adult
Breast cancer
Risk Factors
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Adjuvant therapy
Humans
Cyclophosphamide
Proportional Hazards Models
Gynecology
Proportional hazards model
business.industry
Hazard ratio
Cancer
General Medicine
Middle Aged
medicine.disease
Regimen
Treatment Outcome
Receptors, Estrogen
Chemotherapy, Adjuvant
Doxorubicin
Female
Taxoids
Fluorouracil
Breast disease
business
Follow-Up Studies
medicine.drug
Subjects
Details
- ISSN :
- 00284793
- Database :
- OpenAIRE
- Journal :
- NEW ENGLAND JOURNAL OF MEDICINE, r-FISABIO. Repositorio Institucional de Producción Científica, instname, r-FISABIO: Repositorio Institucional de Producción Científica, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
- Accession number :
- edsair.doi.dedup.....f417b475b3056c58ea363d7f178c0714