Background In an open-label, randomized, phase 3 trial, we comparedthe efficacy and safety of paclitaxel with that of paclitaxelplus bevacizumab, a monoclonal antibody against vascular endothelialgrowth factor, as initial treatment for metastatic breast cancer.
Methods We randomly assigned patients to receive 90 mg of paclitaxelper square meter of body-surface area on days 1, 8, and 15 every4 weeks, either alone or with 10 mg of bevacizumab per kilogramof body weight on days 1 and 15. The primary end point was progression-freesurvival; overall survival was a secondary end point.
Results From December 2001 through May 2004, a total of 722patients were enrolled. Paclitaxel plus bevacizumab significantlyprolonged progression-free survival as compared with paclitaxelalone (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 receivingpaclitaxel plus bevacizumab. Infection was more common in patientsreceiving 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 withpaclitaxel 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.
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