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Previous Volume 357:2666-2676 December 27, 2007 Number 26 Next

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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 [ClinicalTrials.gov] .)

Source Information

From Indiana University Cancer Center, Indianapolis (K.M.); Dana–Farber Cancer Institute, Boston (M.W.); Puget Sound Oncology Consortium, Seattle (J.G.); Memorial Sloan-Kettering Cancer Center, New York (M.D.); Rush–Presbyterian–St. Luke's Medical Center, Chicago (M.C.); Mayo Clinic, Jacksonville, FL (E.A.P.); British Columbia Cancer Agency–Vancouver Cancer Center, Vancouver, BC, Canada (T.S.); Evanston Northwestern Healthcare and Robert H. Lurie Comprehensive Cancer Center of Northwestern University — both in Evanston, IL (D.C.); and Johns Hopkins Kimmel Comprehensive Cancer Center, Baltimore (N.E.D.).

Address reprint requests to Dr. Miller at the Indiana Cancer Pavilion, 535 Barnhill Dr., RT473, Indianapolis, IN 46202, or at kathmill{at}iupui.edu.

Full Text of this Article

Related Letters:

Paclitaxel plus Bevacizumab for Metastatic Breast Cancer
Haines I. E., Miklos G. L. G., Rossi A., Torri V., Gridelli C., Miller K. D., Wang M., Davidson N. E.
Extract | Full Text | PDF  
N Engl J Med 2008; 358:1637-1638, Apr 10, 2008. Correspondence

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