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Annals of Oncology Advance Access originally published online on May 19, 2005
Annals of Oncology 2005 16(8):1297-1304; doi:10.1093/annonc/mdi254
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© 2005 European Society for Medical Oncology

Neoadjuvant docetaxel followed by adjuvant doxorubicin and cyclophosphamide in patients with stage III breast cancer

W. J. Gradishar1,{dagger}, S. B. Wedam2,{dagger}, M. Jahanzeb3, J. Erban4, S. A. Limentani5, K.-T. Tsai6, S. R. Olsen6 and S. M. Swain2,*

1 Northwestern University Feinberg School of Medicine, Chicago, IL; 2 Cancer Therapeutics Branch, Center for Cancer Research, National Cancer Institute, DHHS Bethesda, MD; 3 University of Tennessee Cancer Institute, Memphis, TN; 4 Tufts New England Medical Center, Boston, MA; 5 Carolinas-Hematology Oncology Associates and the Blumenthal Cancer Center, Charlotte, NC; 6 Aventis Pharmaceuticals, Bridgewater, NJ, USA

* Correspondence to: Dr S. M. Swain, Cancer Therapeutics Branch, Center for Cancer Research, National Cancer Institute, DHHS Bethesda, MD, USA. Tel: +1-301-651-6882; Fax: +1-301-496-0047; Email: swains{at}mail.nih.gov

Background: To evaluate clinical and pathologic response to neoadjuvant docetaxel therapy in patients with stage III breast cancer.

Patients and methods: Forty-five patients were planned to receive four cycles of docetaxel 100 mg/m2 every 3 weeks, followed by surgery, four cycles of doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) every 3 weeks, radiation therapy (RT), and tamoxifen when indicated.

Results: After four cycles of neoadjuvant docetaxel, the clinical response rate within the breast was 59% (95% CI 42% to 73%) and overall (breast and axilla) was 49% (95% CI 38% to 72%) in the intention-to-treat (ITT) population. At the time of surgery, 10% (n=4) of patients had a pathologic complete response (pCR) in the breast, 27% (n=11) had a pCR within the axillary lymph nodes, and 7% (n=3) had a pCR in the breast and axilla (95% CI 2% to 21%). An additional 5% (n=2) had minimal residual invasive tumor (<5 mm). The 5-year overall survival rate was 80%. The percentage of patients with grade 3/4 neutropenia was similar during docetaxel (93%) and AC (86%), while a greater percentage of patients had febrile neutropenia during docetaxel treatment (27%) compared with AC treatment (7%).

Conclusions: Neoadjuvant docetaxel followed by surgery, adjuvant AC, hormonal therapy where indicated, and RT is an active regimen for patients with stage III breast cancer.

Key words: neoadjuvant docetaxel, stage II breast cancer


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