A Randomized Trial of Bevacizumab, an Anti-Vascular Endothelial Growth Factor Antibody, for Metastatic Renal Cancer

doi:10.1056/NEJMoa021491

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

A Randomized Trial of Bevacizumab, an Anti–Vascular Endothelial Growth Factor Antibody, for Metastatic Renal Cancer

James C. Yang, M.D., Leah Haworth, B.S.N., Richard M. Sherry, M.D., Patrick Hwu, M.D., Douglas J. Schwartzentruber, M.D., Suzanne L. Topalian, M.D., Seth M. Steinberg, Ph.D., Helen X. Chen, M.D., and Steven A. Rosenberg, M.D., Ph.D.

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by George, D. J.

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ABSTRACT

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

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

Results Minimal toxic effects were seen, with hypertension andasymptomatic proteinuria predominating. The trial was stoppedafter the interim analysis met the criteria for early stopping.With 116 patients randomly assigned to treatment groups (40to placebo, 37 to low-dose antibody, and 39 to high-dose antibody),there was a significant prolongation of the time to progressionof disease in the high-dose–antibody group as comparedwith the placebo group (hazard ratio, 2.55; P<0.001). Therewas a small difference, of borderline significance, betweenthe time to progression of disease in the low-dose–antibodygroup and that in the placebo group (hazard ratio, 1.26; P=0.053).The probability of being progression-free for patients givenhigh-dose antibody, low-dose–antibody, and placebo was64 percent, 39 percent, and 20 percent, respectively, at fourmonths and 30 percent, 14 percent, and 5 percent at eight months.At the last analysis, there were no significant differencesin overall survival between groups (P>0.20 for all comparisons).

Conclusions Bevacizumab can significantly prolong the time toprogression of disease in patients with metastatic renal-cellcancer.

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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N Engl J Med 2003; 349:1674, Oct 23, 2003. Correspondence

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Ruiz, N., Fernandez-Martos, C., Romero, I., Pla, A., Maiquez, J., Calatrava, A., Guillem, V. (2007). Invasive Fungal Infection and Nasal Septum Perforation With Bevacizumab-Based Therapy in Advanced Colon Cancer. JCO 25: 3376-3377 [Full Text]
Varker, K. A., Biber, J. E., Kefauver, C., Jensen, R., Lehman, A., Young, D., Wu, H., Lesinski, G. B., Kendra, K., Chen, H. X., Walker, M. J., Carson, W. E. III (2007). A Randomized Phase 2 Trial of Bevacizumab with or without Daily Low-Dose Interferon Alfa-2b in Metastatic Malignant Melanoma. Ann. Surg. Oncol. 14: 2367-2376 [Abstract] [Full Text]
Hariharan, S, Gustafson, D, Holden, S, McConkey, D, Davis, D, Morrow, M, Basche, M, Gore, L, Zang, C, O'Bryant, C., Baron, A, Gallemann, D, Colevas, D, Eckhardt, S. (2007). Assessment of the biological and pharmacological effects of the {alpha}{nu}{beta}3 and {alpha}{nu}{beta}5 integrin receptor antagonist, cilengitide (EMD 121974), in patients with advanced solid tumors. Ann Oncol 18: 1400-1407 [Abstract] [Full Text]
Rademaker-Lakhai, J. M., Beerepoot, L. V., Mehra, N., Radema, S. A., van Maanen, R., Vermaat, J. S., Witteveen, E. O., Visseren-Grul, C. M., Musib, L., Enas, N., van Hal, G., Beijnen, J. H., Schellens, J. H.M., Voest, E. E. (2007). Phase I Pharmacokinetic and Pharmacodynamic Study of the Oral Protein Kinase C {beta}-Inhibitor Enzastaurin in Combination with Gemcitabine and Cisplatin in Patients with Advanced Cancer. Clin. Cancer Res. 13: 4474-4481 [Abstract] [Full Text]
Sandler, A. (2007). Bevacizumab in Non Small Cell Lung Cancer. Clin. Cancer Res. 13: 4613s-4616s [Abstract] [Full Text]
Verheul, H. M.W., Hammers, H., van Erp, K., Wei, Y., Sanni, T., Salumbides, B., Qian, D. Z., Yancopoulos, G. D., Pili, R. (2007). Vascular Endothelial Growth Factor Trap Blocks Tumor Growth, Metastasis Formation, and Vascular Leakage in an Orthotopic Murine Renal Cell Cancer Model. Clin. Cancer Res. 13: 4201-4208 [Abstract] [Full Text]
Margolin, K., Gordon, M. (2007). Shortening the Infusion Time of Anticancer Drugs: Who Will Benefit?. JCO 25: 2642-2643 [Full Text]
Stein, M. N., Flaherty, K. T. (2007). CCR Drug Updates: Sorafenib and Sunitinib in Renal Cell Carcinoma. Clin. Cancer Res. 13: 3765-3770 [Full Text]
Heiduschka, P., Fietz, H., Hofmeister, S., Schultheiss, S., Mack, A. F., Peters, S., Ziemssen, F., Niggemann, B., Julien, S., Bartz-Schmidt, K. U., Schraermeyer, U., and The Tubingen Bevacizumab Study Group, (2007). Penetration of Bevacizumab through the Retina after Intravitreal Injection in the Monkey. IOVS 48: 2814-2823 [Abstract] [Full Text]
Dirix, L., Maes, H, Sweldens, C (2007). Treatment of arterial hypertension (AHT) associated with angiogenesis inhibitors. Ann Oncol 18: 1121-1122 [Full Text]
Manzano, R. P A, Peyman, G. A, Khan, P., Carvounis, P. E, Kivilcim, M., Ren, M., Lake, J. C, Chevez-Barrios, P. (2007). Inhibition of experimental corneal neovascularisation by bevacizumab (Avastin). Br. J. Ophthalmol. 91: 804-807 [Abstract] [Full Text]
Kolodgie, F. D., Narula, J., Yuan, C., Burke, A. P., Finn, A. V., Virmani, R. (2007). Elimination of Neoangiogenesis for Plaque Stabilization: Is There a Role for Local Drug Therapy?. J Am Coll Cardiol 49: 2093-2101 [Abstract] [Full Text]
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