Abstract | BACKGROUND: METHODS: RESULTS: The addition of capecitabine or gemcitabine to docetaxel therapy, as compared with docetaxel therapy alone, did not significantly increase the rate of pathological complete response (29.7% and 31.8%, respectively, vs. 32.7%; P=0.69). Both capecitabine and gemcitabine were associated with increased toxic effects--specifically, the hand-foot syndrome, mucositis, and neutropenia. The addition of bevacizumab significantly increased the rate of pathological complete response (28.2% without bevacizumab vs. 34.5% with bevacizumab, P=0.02). The effect of bevacizumab on the rate of pathological complete response was not the same in the hormone-receptor-positive and hormone-receptor-negative subgroups. The addition of bevacizumab increased the rates of hypertension, left ventricular systolic dysfunction, the hand-foot syndrome, and mucositis. CONCLUSIONS: The addition of bevacizumab to neoadjuvant chemotherapy significantly increased the rate of pathological complete response, which was the primary end point of this study. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00408408.).
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Authors | Harry D Bear, Gong Tang, Priya Rastogi, Charles E Geyer Jr, André Robidoux, James N Atkins, Luis Baez-Diaz, Adam M Brufsky, Rita S Mehta, Louis Fehrenbacher, James A Young, Francis M Senecal, Rakesh Gaur, Richard G Margolese, Paul T Adams, Howard M Gross, Joseph P Costantino, Sandra M Swain, Eleftherios P Mamounas, Norman Wolmark |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 366
Issue 4
Pg. 310-20
(Jan 26 2012)
ISSN: 1533-4406 [Electronic] United States |
PMID | 22276821
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)
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Chemical References |
- Angiogenesis Inhibitors
- Antibodies, Monoclonal, Humanized
- Taxoids
- Deoxycytidine
- Docetaxel
- Bevacizumab
- Capecitabine
- Doxorubicin
- Cyclophosphamide
- Receptor, ErbB-2
- Fluorouracil
- Gemcitabine
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Topics |
- Adult
- Aged
- Angiogenesis Inhibitors
(administration & dosage, adverse effects)
- Antibodies, Monoclonal, Humanized
(administration & dosage, adverse effects)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Bevacizumab
- Breast Neoplasms
(drug therapy, pathology, surgery)
- Capecitabine
- Cyclophosphamide
(administration & dosage)
- Deoxycytidine
(administration & dosage, analogs & derivatives)
- Disease Progression
- Docetaxel
- Doxorubicin
(administration & dosage)
- Female
- Fluorouracil
(administration & dosage, analogs & derivatives)
- Humans
- Logistic Models
- Mastectomy, Segmental
- Middle Aged
- Neoadjuvant Therapy
- Receptor, ErbB-2
- Taxoids
(administration & dosage)
- Treatment Outcome
- Gemcitabine
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