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Adjuvant docetaxel for node-positive breast cancer.

Martin, Miguel
; 
Pienkowski, Tadeusz
; 
Mackey, John R
; 
Pawlicki, Marek
; 
Guastalla, Jean-Paul
; 
Weaver, Charles
; 
Tomiak, Eva
; 
Al-Tweigeri, Taher
; 
Chap, Linnea
; 
Juhos, Eva
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Abstract
BACKGROUND: We compared docetaxel plus doxorubicin and cyclophosphamide (TAC) with fluorouracil plus doxorubicin and cyclophosphamide (FAC) as adjuvant chemotherapy for operable node-positive breast cancer. METHODS: We randomly assigned 1491 women with axillary node-positive breast cancer to six cycles of treatment with either TAC or FAC as adjuvant chemotherapy after surgery. The primary end point was disease-free survival. RESULTS: At a median follow-up of 55 months, the estimated rates of disease-free survival at five years were 75 percent among the 745 patients randomly assigned to receive TAC and 68 percent among the 746 randomly assigned to receive FAC, representing a 28 percent reduction in the risk of relapse (P=0.001) in the TAC group. The estimated rates of overall survival at five years were 87 percent and 81 percent, respectively. Treatment with TAC resulted in a 30 percent reduction in the risk of death (P=0.008). The incidence of grade 3 or 4 neutropenia was 65.5 percent in the TAC group and 49.3 percent in the FAC group (P<0.001); rates of febrile neutropenia were 24.7 percent and 2.5 percent, respectively (P<0.001). Grade 3 or 4 infections occurred in 3.9 percent of the patients who received TAC and 2.2 percent of those who received FAC (P=0.05); no deaths occurred as a result of infection. Two patients in each group died during treatment. Congestive heart failure and acute myeloid leukemia occurred in less than 2 percent of the patients in each group. Quality-of-life scores decreased during chemotherapy but returned to baseline levels after treatment. CONCLUSIONS: Adjuvant chemotherapy with TAC, as compared with FAC, significantly improves the rates of disease-free and overall survival among women with operable node-positive breast cancer.
Authors
Martin, Miguel
Pienkowski, Tadeusz
Mackey, John R
Pawlicki, Marek
Guastalla, Jean-Paul
Weaver, Charles
Tomiak, Eva
Al-Tweigeri, Taher
Chap, Linnea
Juhos, Eva
Guevin, Raymond
Howell, Anthony
Fornander, Tommy
Hainsworth, John
Coleman, Robert E
Vinholes, Jefferson
Modiano, Manuel
Pinter, Tamas
Tang, Shou C
Colwell, Bruce
Prady, Catherine
Provencher, Louise
Walde, David
Rodriguez-Lescure, Alvaro
Hugh, Judith
Loret, Camille
Rupin, Matthieu
Blitz, Sandra
Jacobs, Philip
Murawsky, Michael
Riva, Alessandro
Vogel, Charles L
Affiliation
Hospital Universitario San Carlos, Madrid, Spain. mmartin@geicam.org
Description
Date
2005-06-02
Publisher
Collections
All Christie Publications
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Keywords
Breast Cancer
Type
Article
Citation
Adjuvant docetaxel for node-positive breast cancer. 2005, 352 (22):2302-13 N. Engl. J. Med.
Journal Title
Journal ISSN
Volume Title
URI
http://hdl.handle.net/10541/76601
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