Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer Journal Article


Authors: Miller, K.; Wang, M.; Gralow, J.; Dickler, M.; Cobleigh, M.; Perez, E. A.; Shenkier, T.; Cella, D.; Davidson, N. E.
Article Title: Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer
Abstract: BACKGROUND: In an open-label, randomized, phase 3 trial, we compared the efficacy and safety of paclitaxel with that of paclitaxel plus bevacizumab, a monoclonal antibody against vascular endothelial growth factor, as initial treatment for metastatic breast cancer. METHODS: We randomly assigned patients to receive 90 mg of paclitaxel per square meter of body-surface area on days 1, 8, and 15 every 4 weeks, either alone or with 10 mg of bevacizumab per kilogram of body weight on days 1 and 15. The primary end point was progression-free survival; overall survival was a secondary end point. RESULTS: From December 2001 through May 2004, a total of 722 patients were enrolled. Paclitaxel plus bevacizumab significantly prolonged progression-free survival as compared with paclitaxel alone (median, 11.8 vs. 5.9 months; hazard ratio for progression, 0.60; P<0.001) and increased the objective response rate (36.9% vs. 21.2%, P<0.001). The overall survival rate, however, was similar in the two groups (median, 26.7 vs. 25.2 months; hazard ratio, 0.88; P = 0.16). Grade 3 or 4 hypertension (14.8% vs. 0.0%, P<0.001), proteinuria (3.6% vs. 0.0%, P<0.001), headache (2.2% vs. 0.0%, P = 0.008), and cerebrovascular ischemia (1.9% vs. 0.0%, P = 0.02) were more frequent in patients receiving paclitaxel plus bevacizumab. Infection was more common in patients receiving paclitaxel plus bevacizumab (9.3% vs. 2.9%, P<0.001), but febrile neutropenia was uncommon (<1% overall). CONCLUSIONS: Initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab prolongs progression-free survival, but not overall survival, as compared with paclitaxel alone. (ClinicalTrials.gov number, NCT00028990.) Copyright © 2007 Massachusetts Medical Society.
Keywords: adult; cancer survival; controlled study; treatment response; aged; aged, 80 and over; middle aged; survival analysis; major clinical study; overall survival; clinical trial; fatigue; neutropenia; bevacizumab; drug dose reduction; drug efficacy; drug safety; heart left ventricle failure; hypertension; monotherapy; side effect; paclitaxel; comparative study; anorexia; quality of life; controlled clinical trial; infection; sensory neuropathy; breast cancer; anemia; bleeding; nausea; randomized controlled trial; stomatitis; thrombocytopenia; vomiting; antineoplastic combined chemotherapy protocols; proportional hazards models; myalgia; antineoplastic agents, phytogenic; combination chemotherapy; breast neoplasms; arthralgia; aspartate aminotransferase blood level; febrile neutropenia; fever; antibodies, monoclonal; disease progression; thrombosis; neoplasm metastasis; receptor, erbb-2; headache; hazard ratio; phase 3 clinical trial; embolism; angiogenesis inhibitors; time series analysis; brain ischemia; digestive system perforation; proteinuria; allergic reaction; hypersensitivity reaction; granulocytopenia
Journal Title: New England Journal of Medicine
Volume: 357
Issue: 26
ISSN: 0028-4793
Publisher: Massachusetts Medical Society  
Date Published: 2007-12-27
Start Page: 2666
End Page: 2676
Language: English
DOI: 10.1056/NEJMoa072113
PUBMED: 18160686
PROVIDER: scopus
DOI/URL:
Notes: --- - "Cited By (since 1996): 960" - "Export Date: 17 November 2011" - "CODEN: NEJMA" - "Source: Scopus"
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  1. Maura N Dickler
    253 Dickler