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Previous Volume 349:427-434 July 31, 2003 Number 5 Next

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ABSTRACT

Background Mutations in the tumor-suppressor gene VHL cause oversecretion of vascular endothelial growth factor by clear-cell renal carcinomas. We conducted a clinical trial to evaluate bevacizumab, a neutralizing antibody against vascular endothelial growth factor, in patients with metastatic renal-cell carcinoma.

Methods A randomized, double-blind, phase 2 trial was conducted comparing placebo with bevacizumab at doses of 3 and 10 mg per kilogram of body weight, given every two weeks; the time to progression of disease and the response rate were primary end points. Crossover from placebo to antibody treatment was allowed, and survival was a secondary end point.

Results Minimal toxic effects were seen, with hypertension and asymptomatic proteinuria predominating. The trial was stopped after the interim analysis met the criteria for early stopping. With 116 patients randomly assigned to treatment groups (40 to placebo, 37 to low-dose antibody, and 39 to high-dose antibody), there was a significant prolongation of the time to progression of disease in the high-dose–antibody group as compared with the placebo group (hazard ratio, 2.55; P<0.001). There was a small difference, of borderline significance, between the time to progression of disease in the low-dose–antibody group and that in the placebo group (hazard ratio, 1.26; P=0.053). The probability of being progression-free for patients given high-dose antibody, low-dose–antibody, and placebo was 64 percent, 39 percent, and 20 percent, respectively, at four months and 30 percent, 14 percent, and 5 percent at eight months. At the last analysis, there were no significant differences in overall survival between groups (P>0.20 for all comparisons).

Conclusions Bevacizumab can significantly prolong the time to progression of disease in patients with metastatic renal-cell cancer.

Source Information

From the Surgery Branch (J.C.Y., L.H., R.M.S., P.H., D.J.S., S.L.T., S.A.R.), the Biostatistics and Data Management Section (S.M.S.), and the Cancer Therapy Evaluation Program (H.X.C.), National Cancer Institute, Bethesda, Md.

Address reprint requests to Dr. Yang at Rm. 2B-37, Bldg. 10, National Institutes of Health, 9000 Rockville Pike, Bethesda, MD 20892, or at james_yang{at}nih.gov.

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Bevacizumab in Renal-Cell Cancer
Sonpavde G.
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N Engl J Med 2003; 349:1674, Oct 23, 2003. Correspondence

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• Tabernero, J. (2007). The Role of VEGF and EGFR Inhibition: Implications for Combining Anti-VEGF and Anti-EGFR Agents. Mol Cancer Res 5: 203-220 [Abstract] [Full Text]  
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