Correspondence

Bevacizumab in Renal-Cell Cancer

N Engl J Med 2003; 349:1674October 23, 2003

Article

To the Editor:

In the report on their randomized, placebo-controlled, phase 2 trial evaluating bevacizumab, Yang et al. (July 31 issue)1 conclude that bevacizumab significantly prolongs the time to progression of metastatic renal-cell cancer. I believe this conclusion is inappropriate. Although the patients are randomly assigned to the treatment groups in a randomized phase 2 study, it is not equivalent to a phase 3 study. The purpose of a randomized phase 2 trial is to select one of several novel regimens for the next phase of testing. One can only be reassured that the selected regimen is probably not significantly worse than the other regimens being evaluated.2 Therefore, the proper conclusion is that bevacizumab at a dose of 10 mg per kilogram of body weight appears to be promising in the treatment of metastatic renal cancer and should be studied further.

Guru Sonpavde, M.D.
Baylor College of Medicine, Houston, TX 77030
gurus@bcm.tmc.edu

2 References

1. 1

   Yang JC, Haworth L, Sherry RM, et al. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med 2003;349:427-434
   Full Text | Web of Science | Medline

2. 2

   The design of clinical trials. In: Green S, Benedetti J, Crowley J. Clinical trials in oncology. 2nd ed. Boca Raton, Fla.: CRC Press, 2003:41-76.
   

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