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Previous Volume 356:125-134 January 11, 2007 Number 2 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Brugarolas, J. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article PubMed Citation

ABSTRACT

Background We conducted a phase 3, randomized, double-blind, placebo-controlled trial of sorafenib, a multikinase inhibitor of tumor-cell proliferation and angiogenesis, in patients with advanced clear-cell renal-cell carcinoma.

Methods From November 2003 to March 2005, we randomly assigned 903 patients with renal-cell carcinoma that was resistant to standard therapy to receive either continuous treatment with oral sorafenib (at a dose of 400 mg twice daily) or placebo; 451 patients received sorafenib and 452 received placebo. The primary end point was overall survival. A single planned analysis of progression-free survival in January 2005 showed a statistically significant benefit of sorafenib over placebo. Consequently, crossover was permitted from placebo to sorafenib, beginning in May 2005.

Results At the January 2005 cutoff, the median progression-free survival was 5.5 months in the sorafenib group and 2.8 months in the placebo group (hazard ratio for disease progression in the sorafenib group, 0.44; 95% confidence interval [CI], 0.35 to 0.55; P<0.01). The first interim analysis of overall survival in May 2005 showed that sorafenib reduced the risk of death, as compared with placebo (hazard ratio, 0.72; 95% CI, 0.54 to 0.94; P=0.02), although this benefit was not statistically significant according to the O'Brien–Fleming threshold. Partial responses were reported as the best response in 10% of patients receiving sorafenib and in 2% of those receiving placebo (P<0.001). Diarrhea, rash, fatigue, and hand–foot skin reactions were the most common adverse events associated with sorafenib. Hypertension and cardiac ischemia were rare serious adverse events that were more common in patients receiving sorafenib than in those receiving placebo.

Conclusions As compared with placebo, treatment with sorafenib prolongs progression-free survival in patients with advanced clear-cell renal-cell carcinoma in whom previous therapy has failed; however, treatment is associated with increased toxic effects. (ClinicalTrials.gov number, NCT00073307 [ClinicalTrials.gov] .)

Source Information

From Institut Gustave Roussy, Villejuif, France (B.E.); Cambridge Research Institute, Cambridge, United Kingdom (T.E.); University of Chicago, Chicago (W.M.S., A.A.D.); Military School of Medicine, Warsaw, Poland (C.S.); Hôpital Européen Georges Pompidou, Paris (S.O.); Klinikum Grosshadern der Ludwig Maximilians Universität, Munich, Germany (M. Siebels); Centre Léon Bérard, Lyon, France (S.N.); Institut Claudius Regaud, Toulouse, France (C.C.); Wojewodzka Przychodnia Onkolog, Gdansk, Poland (E.S.); Centre René Gauducheau, Saint-Herblain, France (F.R.); Centrum Onkologii, Warsaw, Poland (T.D.); Baylor Charles A. Sammons Cancer Center, Dallas (T.E.H.); Royal Marsden Hospital, Surrey, United Kingdom (M.G.); Onyx Pharmaceuticals, Emeryville, CA (S.F.); Bayer Pharmaceuticals, West Haven, CT (B.S., M. Shan, R.S.); and Cleveland Clinic Taussig Cancer Center, Cleveland (R.M.B.).

Address reprint requests to Dr. Escudier at the Department of Medicine, Institut Gustave Roussy, 39 rue Camille Desmoulins, 94805 Villejuif, France, or at escudier{at}igr.fr.

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• Schneider, B. P., Wang, M., Radovich, M., Sledge, G. W., Badve, S., Thor, A., Flockhart, D. A., Hancock, B., Davidson, N., Gralow, J., Dickler, M., Perez, E. A., Cobleigh, M., Shenkier, T., Edgerton, S., Miller, K. D. (2008). Association of Vascular Endothelial Growth Factor and Vascular Endothelial Growth Factor Receptor-2 Genetic Polymorphisms With Outcome in a Trial of Paclitaxel Compared With Paclitaxel Plus Bevacizumab in Advanced Breast Cancer: ECOG 2100. JCO 26: 4672-4678 [Abstract] [Full Text]  
• Ng, C. S., Wood, C. G., Silverman, P. M., Tannir, N. M., Tamboli, P., Sandler, C. M. (2008). Renal Cell Carcinoma: Diagnosis, Staging, and Surveillance. Am. J. Roentgenol. 191: 1220-1232 [Abstract] [Full Text]  
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• Matsui, J., Funahashi, Y., Uenaka, T., Watanabe, T., Tsuruoka, A., Asada, M. (2008). Multi-Kinase Inhibitor E7080 Suppresses Lymph Node and Lung Metastases of Human Mammary Breast Tumor MDA-MB-231 via Inhibition of Vascular Endothelial Growth Factor-Receptor (VEGF-R) 2 and VEGF-R3 Kinase. Clin. Cancer Res. 14: 5459-5465 [Abstract] [Full Text]  
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• Lacouture, M. E., Wu, S., Robert, C., Atkins, M. B., Kong, H. H., Guitart, J., Garbe, C., Hauschild, A., Puzanov, I., Alexandrescu, D. T., Anderson, R. T., Wood, L., Dutcher, J. P. (2008). Evolving Strategies for the Management of Hand-Foot Skin Reaction Associated with the Multitargeted Kinase Inhibitors Sorafenib and Sunitinib. The Oncologist 13: 1001-1011 [Abstract] [Full Text]  
• Salama, J. K., Chmura, S. J., Mehta, N., Yenice, K. M., Stadler, W. M., Vokes, E. E., Haraf, D. J., Hellman, S., Weichselbaum, R. R. (2008). An Initial Report of a Radiation Dose-Escalation Trial in Patients with One to Five Sites of Metastatic Disease. Clin. Cancer Res. 14: 5255-5259 [Abstract] [Full Text]  
• Crispen, P. L., Sheinin, Y., Roth, T. J., Lohse, C. M., Kuntz, S. M., Frigola, X., Thompson, R. H., Boorjian, S. A., Dong, H., Leibovich, B. C., Blute, M. L., Kwon, E. D. (2008). Tumor Cell and Tumor Vasculature Expression of B7-H3 Predict Survival in Clear Cell Renal Cell Carcinoma. Clin. Cancer Res. 14: 5150-5157 [Abstract] [Full Text]  
• Cannistra, S. A. (2008). Challenges and Pitfalls of Combining Targeted Agents in Phase I Studies. JCO 26: 3665-3667 [Full Text]  
• Azad, N. S., Posadas, E. M., Kwitkowski, V. E., Steinberg, S. M., Jain, L., Annunziata, C. M., Minasian, L., Sarosy, G., Kotz, H. L., Premkumar, A., Cao, L., McNally, D., Chow, C., Chen, H. X., Wright, J. J., Figg, W. D., Kohn, E. C. (2008). Combination Targeted Therapy With Sorafenib and Bevacizumab Results in Enhanced Toxicity and Antitumor Activity. JCO 26: 3709-3714 [Abstract] [Full Text]  
• Dodd, L. E., Korn, E. L., Freidlin, B., Jaffe, C. C., Rubinstein, L. V., Dancey, J., Mooney, M. M. (2008). Blinded Independent Central Review of Progression-Free Survival in Phase III Clinical Trials: Important Design Element or Unnecessary Expense?. JCO 26: 3791-3796 [Abstract] [Full Text]  
• Carden, C. P., Larkin, J. M.G., Rosenthal, M. A. (2008). What is the risk of intracranial bleeding during anti-VEGF therapy?. Neuro Oncol Duke 10: 624-630 [Abstract] [Full Text]  
• Ding, Q., Huo, L., Yang, J.-Y., Xia, W., Wei, Y., Liao, Y., Chang, C.-J., Yang, Y., Lai, C.-C., Lee, D.-F., Yen, C.-J., Chen, Y.-J. R., Hsu, J.-M., Kuo, H.-P., Lin, C.-Y., Tsai, F.-J., Li, L.-Y., Tsai, C.-H., Hung, M.-C. (2008). Down-regulation of Myeloid Cell Leukemia-1 through Inhibiting Erk/Pin 1 Pathway by Sorafenib Facilitates Chemosensitization in Breast Cancer. Cancer Res. 68: 6109-6117 [Abstract] [Full Text]