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Bevacizumab added to neoadjuvant chemotherapy for breast cancer.
- Source :
-
The New England journal of medicine [N Engl J Med] 2012 Jan 26; Vol. 366 (4), pp. 310-20. - Publication Year :
- 2012
-
Abstract
- Background: Bevacizumab and the antimetabolites capecitabine and gemcitabine have been shown to improve outcomes when added to taxanes in patients with metastatic breast cancer. The primary aims of this trial were to determine whether the addition of capecitabine or gemcitabine to neoadjuvant chemotherapy with docetaxel, followed by doxorubicin plus cyclophosphamide, would increase the rates of pathological complete response in the breast in women with operable, human epidermal growth factor receptor 2 (HER2)-negative breast cancer and whether adding bevacizumab to these chemotherapy regimens would increase the rates of pathological complete response.<br />Methods: We randomly assigned 1206 patients to receive neoadjuvant therapy consisting of docetaxel (100 mg per square meter of body-surface area on day 1), docetaxel (75 mg per square meter on day 1) plus capecitabine (825 mg per square meter twice a day on days 1 to 14), or docetaxel (75 mg per square meter on day 1) plus gemcitabine (1000 mg per square meter on days 1 and 8) for four cycles, with all regimens followed by treatment with doxorubicin-cyclophosphamide for four cycles. Patients were also randomly assigned to receive or not to receive bevacizumab (15 mg per kilogram of body weight) for the first six cycles of chemotherapy.<br />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.<br />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.).
- Subjects :
- Adult
Aged
Angiogenesis Inhibitors adverse effects
Antibodies, Monoclonal, Humanized adverse effects
Antineoplastic Combined Chemotherapy Protocols adverse effects
Bevacizumab
Breast Neoplasms pathology
Breast Neoplasms surgery
Capecitabine
Cyclophosphamide administration & dosage
Deoxycytidine administration & dosage
Deoxycytidine analogs & derivatives
Disease Progression
Docetaxel
Doxorubicin administration & dosage
Female
Fluorouracil administration & dosage
Fluorouracil analogs & derivatives
Humans
Logistic Models
Mastectomy, Segmental
Middle Aged
Neoadjuvant Therapy
Taxoids administration & dosage
Treatment Outcome
Gemcitabine
Angiogenesis Inhibitors administration & dosage
Antibodies, Monoclonal, Humanized administration & dosage
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Breast Neoplasms drug therapy
Receptor, ErbB-2
Subjects
Details
- Language :
- English
- ISSN :
- 1533-4406
- Volume :
- 366
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- The New England journal of medicine
- Publication Type :
- Academic Journal
- Accession number :
- 22276821
- Full Text :
- https://doi.org/10.1056/NEJMoa1111097