FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

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.

Full Text of this Article

This article has been cited by other articles:

• Thiam, R., Fournier, L. S., Trinquart, L., Medioni, J., Chatellier, G., Balvay, D., Escudier, B., Dromain, C., Cuenod, C. A., Oudard, S. (2009). Optimizing the size variation threshold for the CT evaluation of response in metastatic renal cell carcinoma treated with sunitinib. Ann Oncol 0: mdp466v1-mdp466 [Abstract] [Full Text]  
• Overkleeft, E. N. M., Goldschmeding, R., van Reekum, F., Voest, E. E., Verheul, H. M. W. (2009). Nephrotic syndrome caused by the angiogenesis inhibitor sorafenib. Ann Oncol 0: mdp472v1-mdp472 [Full Text]  
• Dorff, T. B., Goldkorn, A., Quinn, D. I. (2009). Review: Targeted therapy in renal cancer. Therapeutic Advances in Medical Oncology 1: 183-205 [Abstract]  
• Suzuki, H., Ohkuchi, A., Matsubara, S., Takei, Y., Murakami, M., Shibuya, M., Suzuki, M., Sato, Y. (2009). Effect of Recombinant Placental Growth Factor 2 on Hypertension Induced by Full-Length Mouse Soluble fms-Like Tyrosine Kinase 1 Adenoviral Vector in Pregnant Mice. Hypertension 54: 1129-1135 [Abstract] [Full Text]  
• Tang, P. A., Pond, G. R., Chen, E. X. (2009). Influence of an independent review committee on assessment of response rate and progression-free survival in phase III clinical trials. Ann Oncol 0: mdp478v1-mdp478 [Abstract] [Full Text]  
• Massard, C., Zonierek, J., Gross-Goupil, M., Fizazi, K., Szczylik, C., Escudier, B. (2009). Incidence of brain metastases in renal cell carcinoma treated with sorafenib. Ann Oncol 0: mdp411v1-mdp411 [Abstract] [Full Text]  
• Zangari, M., Fink, L. M., Elice, F., Zhan, F., Adcock, D. M., Tricot, G. J. (2009). Thrombotic Events in Patients With Cancer Receiving Antiangiogenesis Agents. JCO 27: 4865-4873 [Abstract] [Full Text]  
• Daenen, L. G., Shaked, Y., Man, S., Xu, P., Voest, E. E., Hoffman, R. M., Chaplin, D. J., Kerbel, R. S. (2009). Low-dose metronomic cyclophosphamide combined with vascular disrupting therapy induces potent antitumor activity in preclinical human tumor xenograft models. Molecular Cancer Therapeutics 8: 2872-2881 [Abstract] [Full Text]  
• Maitland, M. L., Kasza, K. E., Karrison, T., Moshier, K., Sit, L., Black, H. R., Undevia, S. D., Stadler, W. M., Elliott, W. J., Ratain, M. J. (2009). Ambulatory Monitoring Detects Sorafenib-Induced Blood Pressure Elevations on the First Day of Treatment. Clin. Cancer Res. 15: 6250-6257 [Abstract] [Full Text]  
• Rini, B. I., Garcia, J. A., Cooney, M. M., Elson, P., Tyler, A., Beatty, K., Bokar, J., Mekhail, T., Bukowski, R.M., Budd, G. T., Triozzi, P., Borden, E., Ivy, P., Chen, H. X., Dowlati, A., Dreicer, R. (2009). A Phase I Study of Sunitinib plus Bevacizumab in Advanced Solid Tumors. Clin. Cancer Res. 15: 6277-6283 [Abstract] [Full Text]  
• Ishiyama, K., Takami, A., Suzuki, S., Konaka, H., Namiki, M., Ooi, A., Nakao, S. (2009). Relationship Between Tumor-infiltrating T Lymphocytes and Clinical Response After Reduced-intensity Allogeneic Hematopoietic Stem Cell Transplantation for Advanced Renal Cell Carcinoma: A Single Center Prospective Study. Jpn J Clin Oncol 0: hyp104v1-hyp104 [Abstract] [Full Text]  
• Rini, B. I., Wilding, G., Hudes, G., Stadler, W. M., Kim, S., Tarazi, J., Rosbrook, B., Trask, P. C., Wood, L., Dutcher, J. P. (2009). Phase II Study of Axitinib in Sorafenib-Refractory Metastatic Renal Cell Carcinoma. JCO 27: 4462-4468 [Abstract] [Full Text]  
• Di Lorenzo, G., Carteni, G., Autorino, R., Bruni, G., Tudini, M., Rizzo, M., Aieta, M., Gonnella, A., Rescigno, P., Perdona, S., Giannarini, G., Pignata, S., Longo, N., Palmieri, G., Imbimbo, C., De Laurentiis, M., Mirone, V., Ficorella, C., De Placido, S. (2009). Phase II Study of Sorafenib in Patients With Sunitinib-Refractory Metastatic Renal Cell Cancer. JCO 27: 4469-4474 [Abstract] [Full Text]  
• Blumenschein, G. R. Jr, Gatzemeier, U., Fossella, F., Stewart, D. J., Cupit, L., Cihon, F., O'Leary, J., Reck, M. (2009). Phase II, Multicenter, Uncontrolled Trial of Single-Agent Sorafenib in Patients With Relapsed or Refractory, Advanced Non-Small-Cell Lung Cancer. JCO 27: 4274-4280 [Abstract] [Full Text]  
• Cersosimo, R. J. (2009). Renal cell carcinoma with an emphasis on drug therapy of advanced disease, part 1. Am J Health Syst Pharm 66: 1525-1536 [Abstract] [Full Text]  
• Jonasch, E., Wood, C. G., Matin, S. F., Tu, S.-M., Pagliaro, L. C., Corn, P. G., Aparicio, A., Tamboli, P., Millikan, R. E., Wang, X., Araujo, J. C., Arap, W., Tannir, N. (2009). Phase II Presurgical Feasibility Study of Bevacizumab in Untreated Patients With Metastatic Renal Cell Carcinoma. JCO 27: 4076-4081 [Abstract] [Full Text]  
• Eskens, F. A.L.M., Steeghs, N., Verweij, J., Bloem, J. L., Christensen, O., van Doorn, L., Ouwerkerk, J., de Jonge, M. J.A., Nortier, J. W.R., Kraetzschmar, J., Rajagopalan, P., Gelderblom, H. (2009). Phase I Dose Escalation Study of Telatinib, a Tyrosine Kinase Inhibitor of Vascular Endothelial Growth Factor Receptor 2 and 3, Platelet-Derived Growth Factor Receptor {beta}, and c-Kit, in Patients With Advanced or Metastatic Solid Tumors. JCO 27: 4169-4176 [Abstract] [Full Text]  
• Scialpi, M., Brunese, L., Piscioli, I., Rotondo, A., Pedrosa, I., Sun, M. R. M., Genega, E. M., Atkins, M. B., Rofsky, N. M. (2009). Dynamic Contrast-enhanced MR Imaging for Differentiation of Renal Cell Carcinoma Subtypes: Myth or Reality?. Radiology 252: 929-931 [Full Text]  
• Morelli, M. P., Brown, A. M., Pitts, T. M., Tentler, J. J., Ciardiello, F., Ryan, A., Jurgensmeier, J. M., Eckhardt, S. G. (2009). Targeting vascular endothelial growth factor receptor-1 and -3 with cediranib (AZD2171): effects on migration and invasion of gastrointestinal cancer cell lines. Molecular Cancer Therapeutics 8: 2546-2558 [Abstract] [Full Text]  
• Fojo, T., Grady, C. (2009). How Much Is Life Worth: Cetuximab, Non-Small Cell Lung Cancer, and the $440 Billion Question. JNCI J Natl Cancer Inst 101: 1044-1048 [Abstract] [Full Text]  
• VAZIRI, S. A.J., GRABOWSKI, D. R., HILL, J., RYBICKI, L. R., BURK, R., BUKOWSKI, R. M., GANAPATHI, M. K., GANAPATHI, R. (2009). Inhibition of Proteasome Activity by Bortezomib in Renal Cancer Cells Is p53 Dependent and VHL Independent. Anticancer Res 29: 2961-2969 [Abstract] [Full Text]  
• Kim, A., Balis, F. M., Widemann, B. C. (2009). Sorafenib and Sunitinib. The Oncologist 14: 800-805 [Full Text]  
• Herbst, R. S., Hong, D., Chap, L., Kurzrock, R., Jackson, E., Silverman, J. M., Rasmussen, E., Sun, Y.-N., Zhong, D., Hwang, Y. C., Evelhoch, J. L., Oliner, J. D., Le, N., Rosen, L. S. (2009). Safety, Pharmacokinetics, and Antitumor Activity of AMG 386, a Selective Angiopoietin Inhibitor, in Adult Patients With Advanced Solid Tumors. JCO 27: 3557-3565 [Abstract] [Full Text]  
• Escudier, B., Eisen, T., Stadler, W. M., Szczylik, C., Oudard, S., Staehler, M., Negrier, S., Chevreau, C., Desai, A. A., Rolland, F., Demkow, T., Hutson, T. E., Gore, M., Anderson, S., Hofilena, G., Shan, M., Pena, C., Lathia, C., Bukowski, R. M. (2009). Sorafenib for Treatment of Renal Cell Carcinoma: Final Efficacy and Safety Results of the Phase III Treatment Approaches in Renal Cancer Global Evaluation Trial. JCO 27: 3312-3318 [Abstract] [Full Text]  
• Motzer, R. J., Molina, A. M. (2009). Targeting Renal Cell Carcinoma. JCO 27: 3274-3276 [Full Text]  
• Larkin, J. M.G., Kipps, E. L.S., Powell, C. J., Swanton, C. (2009). Review: Systemic therapy for advanced renal cell carcinoma. Therapeutic Advances in Medical Oncology 1: 15-27 [Abstract]  
• Rini, B. I. (2009). Metastatic Renal Cell Carcinoma: Many Treatment Options, One Patient. JCO 27: 3225-3234 [Abstract] [Full Text]  
• Banerjee, S., Gore, M. (2009). The Future of Targeted Therapies in Ovarian Cancer. The Oncologist 14: 706-716 [Abstract] [Full Text]  
• Yeh, E. T.H., Bickford, C. L. (2009). Cardiovascular complications of cancer therapy: incidence, pathogenesis, diagnosis, and management.. J Am Coll Cardiol 53: 2231-2247 [Abstract] [Full Text]  
• Ichihara, E., Ohashi, K., Takigawa, N., Osawa, M., Ogino, A., Tanimoto, M., Kiura, K. (2009). Effects of Vandetanib on Lung Adenocarcinoma Cells Harboring Epidermal Growth Factor Receptor T790M Mutation In vivo. Cancer Res. 69: 5091-5098 [Abstract] [Full Text]  
• Hauschild, A., Agarwala, S. S., Trefzer, U., Hogg, D., Robert, C., Hersey, P., Eggermont, A., Grabbe, S., Gonzalez, R., Gille, J., Peschel, C., Schadendorf, D., Garbe, C., O'Day, S., Daud, A., White, J. M., Xia, C., Patel, K., Kirkwood, J. M., Keilholz, U. (2009). Results of a Phase III, Randomized, Placebo-Controlled Study of Sorafenib in Combination With Carboplatin and Paclitaxel As Second-Line Treatment in Patients With Unresectable Stage III or Stage IV Melanoma. JCO 27: 2823-2830 [Abstract] [Full Text]  
• Loges, S., Schmidt, T., Carmeliet, P. (2009). "Antimyeloangiogenic" Therapy for Cancer by Inhibiting PlGF. Clin. Cancer Res. 15: 3648-3653 [Abstract] [Full Text]  
• Chi, A. S., Sorensen, A. G., Jain, R. K., Batchelor, T. T. (2009). Angiogenesis as a Therapeutic Target in Malignant Gliomas. The Oncologist 14: 621-636 [Abstract] [Full Text]  
• Hanrahan, E. O., Ryan, A. J., Mann, H., Kennedy, S. J., Langmuir, P., Natale, R. B., Herbst, R. S., Johnson, B. E., Heymach, J. V. (2009). Baseline Vascular Endothelial Growth Factor Concentration as a Potential Predictive Marker of Benefit from Vandetanib in Non-Small Cell Lung Cancer. Clin. Cancer Res. 15: 3600-3609 [Abstract] [Full Text]  
• Iguchi, M., Matsumoto, M., Hojo, K., Wada, T., Matsuo, Y., Arimura, A., Abe, K. (2009). Antitumor Efficacy of Recombinant Human Interleukin-2 Combined with Sorafenib Against Mouse Renal Cell Carcinoma. Jpn J Clin Oncol 39: 303-309 [Abstract] [Full Text]  
• Izzedine, H., Ederhy, S., Goldwasser, F., Soria, J. C., Milano, G., Cohen, A., Khayat, D., Spano, J. P. (2009). Management of hypertension in angiogenesis inhibitor-treated patients. Ann Oncol 20: 807-815 [Abstract] [Full Text]  
• Vikram, R., Ng, C. S., Tamboli, P., Tannir, N. M., Jonasch, E., Matin, S. F., Wood, C. G., Sandler, C. M. (2009). Papillary Renal Cell Carcinoma: Radiologic-Pathologic Correlation and Spectrum of Disease1. RadioGraphics 29: 741-754 [Abstract] [Full Text]  
• Sternberg, C. N. (2009). Expanding the boundaries of clinical practice: building on experience with targeted therapies. Ann Oncol 20: i1-i6 [Abstract] [Full Text]  
• Ravaud, A. (2009). How to optimise treatment compliance in metastatic renal cell carcinoma with targeted agents. Ann Oncol 20: i7-i12 [Abstract] [Full Text]  
• Bellmunt, J. (2009). Future developments in renal cell carcinoma. Ann Oncol 20: i13-i17 [Abstract] [Full Text]  
• Escudier, B., Kataja, V., On behalf of the ESMO Guidelines Working Group, (2009). Renal cell carcinoma: ESMO Clinical Recommendations for diagnosis, treatment and follow-up. Ann Oncol 20: iv81-iv82 [Full Text]  
• Miller, A. A., Murry, D. J., Owzar, K., Hollis, D. R., Kennedy, E. B., Abou-Alfa, G., Desai, A., Hwang, J., Villalona-Calero, M. A., Dees, E. C., Lewis, L. D., Fakih, M. G., Edelman, M. J., Millard, F., Frank, R. C., Hohl, R. J., Ratain, M. J. (2009). Phase I and Pharmacokinetic Study of Sorafenib in Patients With Hepatic or Renal Dysfunction: CALGB 60301. JCO 27: 1800-1805 [Abstract] [Full Text]  
• Barros Costa, R. L. (2009). Review Article: Targeted Therapy: Comprehensive Review. AM J HOSP PALLIAT CARE 26: 137-146 [Abstract]  
• Pulido, J. S, Itty, S. (2009). Systemic antiangiogenic therapy: what goes around.... Br J Ophthalmol 93: 420-421 [Full Text]  
• Soria, J.-C., Massard, C., Izzedine, H. (2009). From Theoretical Synergy to Clinical Supra-Additive Toxicity. JCO 27: 1359-1361 [Full Text]  
• Dhani, N., Tu, D., Sargent, D. J., Seymour, L., Moore, M. J. (2009). Alternate Endpoints for Screening Phase II Studies. Clin. Cancer Res. 15: 1873-1882 [Abstract] [Full Text]  
• Escudier, B., Szczylik, C., Hutson, T. E., Demkow, T., Staehler, M., Rolland, F., Negrier, S., Laferriere, N., Scheuring, U. J., Cella, D., Shah, S., Bukowski, R. M. (2009). Randomized Phase II Trial of First-Line Treatment With Sorafenib Versus Interferon Alfa-2a in Patients With Metastatic Renal Cell Carcinoma. JCO 27: 1280-1289 [Abstract] [Full Text]  
• Klatte, T., Seligson, D. B., LaRochelle, J., Shuch, B., Said, J. W., Riggs, S. B., Zomorodian, N., Kabbinavar, F. F., Pantuck, A. J., Belldegrun, A. S. (2009). Molecular Signatures of Localized Clear Cell Renal Cell Carcinoma to Predict Disease-Free Survival after Nephrectomy. Cancer Epidemiol. Biomarkers Prev. 18: 894-900 [Abstract] [Full Text]  
• Ma, W. W., Adjei, A. A. (2009). Novel Agents on the Horizon for Cancer Therapy. CA Cancer J Clin 59: 111-137 [Abstract] [Full Text]  
• Sun, M. R. M., Ngo, L., Genega, E. M., Atkins, M. B., Finn, M. E., Rofsky, N. M., Pedrosa, I. (2009). Renal Cell Carcinoma: Dynamic Contrast-enhanced MR Imaging for Differentiation of Tumor Subtypes--Correlation with Pathologic Findings. Radiology 250: 793-802 [Abstract] [Full Text]  
• Sharma, A., Sharma, A. K., Madhunapantula, S. V., Desai, D., Huh, S. J., Mosca, P., Amin, S., Robertson, G. P. (2009). Targeting Akt3 Signaling in Malignant Melanoma Using Isoselenocyanates. Clin. Cancer Res. 15: 1674-1685 [Abstract] [Full Text]  
• Anderson, R., Jatoi, A., Robert, C., Wood, L. S., Keating, K. N., Lacouture, M. E. (2009). Search for Evidence-Based Approaches for the Prevention and Palliation of Hand-Foot Skin Reaction (HFSR) Caused by the Multikinase Inhibitors (MKIs). The Oncologist 14: 291-302 [Abstract] [Full Text]  
• Azad, N. S., Aragon-Ching, J. B., Dahut, W. L., Gutierrez, M., Figg, W. D., Jain, L., Steinberg, S. M., Turner, M. L., Kohn, E. C., Kong, H. H. (2009). Hand-Foot Skin Reaction Increases with Cumulative Sorafenib Dose and with Combination Anti-Vascular Endothelial Growth Factor Therapy. Clin. Cancer Res. 15: 1411-1416 [Abstract] [Full Text]  
• Winn, S. K., Ellis, S., Savage, P., Sampson, S., Marsh, J. E. (2009). Biopsy-proven acute interstitial nephritis associated with the tyrosine kinase inhibitor sunitinib: a class effect?. Nephrol Dial Transplant 24: 673-675 [Abstract] [Full Text]  
• Jilaveanu, L., Zito, C., Lee, S. J., Nathanson, K. L., Camp, R. L., Rimm, D. L., Flaherty, K. T., Kluger, H. M. (2009). Expression of Sorafenib Targets in Melanoma Patients Treated with Carboplatin, Paclitaxel and Sorafenib. Clin. Cancer Res. 15: 1076-1085 [Abstract] [Full Text]  
• Houben, R., Voigt, H., Noelke, C., Hofmeister, V., Becker, J. C., Schrama, D. (2009). MAPK-independent impairment of T-cell responses by the multikinase inhibitor sorafenib. Molecular Cancer Therapeutics 8: 433-440 [Abstract] [Full Text]  
• Ma, J., Waxman, D. J. (2009). Dominant Effect of Antiangiogenesis in Combination Therapy Involving Cyclophosphamide and Axitinib. Clin. Cancer Res. 15: 578-588 [Abstract] [Full Text]  
• Golshayan, A. R., George, S., Heng, D. Y., Elson, P., Wood, L. S., Mekhail, T. M., Garcia, J. A., Aydin, H., Zhou, M., Bukowski, R. M., Rini, B. I. (2009). Metastatic Sarcomatoid Renal Cell Carcinoma Treated With Vascular Endothelial Growth Factor-Targeted Therapy. JCO 27: 235-241 [Abstract] [Full Text]  
• Moreno-Aspitia, A., Morton, R. F., Hillman, D. W., Lingle, W. L., Rowland, K. M. Jr, Wiesenfeld, M., Flynn, P. J., Fitch, T. R., Perez, E. A. (2009). Phase II Trial of Sorafenib in Patients With Metastatic Breast Cancer Previously Exposed to Anthracyclines or Taxanes: North Central Cancer Treatment Group and Mayo Clinic Trial N0336. JCO 27: 11-15 [Abstract] [Full Text]  
• Schomber, T., Zumsteg, A., Strittmatter, K., Crnic, I., Antoniadis, H., Littlewood-Evans, A., Wood, J., Christofori, G. (2009). Differential effects of the vascular endothelial growth factor receptor inhibitor PTK787/ZK222584 on tumor angiogenesis and tumor lymphangiogenesis. Molecular Cancer Therapeutics 8: 55-63 [Abstract] [Full Text]  
• Brugarolas, J. (2009). Molecular Pathways and Targeted Therapies for Renal Cell Carcinoma. Am Soc Clin Oncol Ed Book 2009: 710-715 [Abstract] [Full Text]  
• Pinter, M., Sieghart, W., Graziadei, I., Vogel, W., Maieron, A., Konigsberg, R., Weissmann, A., Kornek, G., Plank, C., Peck-Radosavljevic, M. (2009). Sorafenib in Unresectable Hepatocellular Carcinoma from Mild to Advanced Stage Liver Cirrhosis. The Oncologist 14: 70-76 [Abstract] [Full Text]  
• Biswas, S., Kelly, J., Eisen, T. (2009). Cytoreductive Nephrectomy in Metastatic Clear-Cell Renal Cell Carcinoma: Perspectives in the Tyrosine Kinase Inhibitor Era. The Oncologist 14: 52-59 [Abstract] [Full Text]  
• Ma, J., Waxman, D. J. (2008). Combination of antiangiogenesis with chemotherapy for more effective cancer treatment. Molecular Cancer Therapeutics 7: 3670-3684 [Abstract] [Full Text]  
• Rini, B. I., Halabi, S., Rosenberg, J. E., Stadler, W. M., Vaena, D. A., Ou, S.-S., Archer, L., Atkins, J. N., Picus, J., Czaykowski, P., Dutcher, J., Small, E. J. (2008). Bevacizumab Plus Interferon Alfa Compared With Interferon Alfa Monotherapy in Patients With Metastatic Renal Cell Carcinoma: CALGB 90206. JCO 26: 5422-5428 [Abstract] [Full Text]  
• Hu-Lowe, D. D., Zou, H. Y., Grazzini, M. L., Hallin, M. E., Wickman, G. R., Amundson, K., Chen, J. H., Rewolinski, D. A., Yamazaki, S., Wu, E. Y., McTigue, M. A., Murray, B. W., Kania, R. S., O'Connor, P., Shalinsky, D. R., Bender, S. L. (2008). Nonclinical Antiangiogenesis and Antitumor Activities of Axitinib (AG-013736), an Oral, Potent, and Selective Inhibitor of Vascular Endothelial Growth Factor Receptor Tyrosine Kinases 1, 2, 3. Clin. Cancer Res. 14: 7272-7283 [Abstract] [Full Text]  
• Schmidinger, M., Zielinski, C. C., Vogl, U. M., Bojic, A., Bojic, M., Schukro, C., Ruhsam, M., Hejna, M., Schmidinger, H. (2008). Cardiac Toxicity of Sunitinib and Sorafenib in Patients With Metastatic Renal Cell Carcinoma. JCO 26: 5204-5212 [Abstract] [Full Text]  
• Lacouture, M. E., Reilly, L. M., Gerami, P., Guitart, J. (2008). Hand foot skin reaction in cancer patients treated with the multikinase inhibitors sorafenib and sunitinib. Ann Oncol 19: 1955-1961 [Abstract] [Full Text]  
• Loriot, Y., Boudou-Rouquette, P., Billemont, B., Ropert, S., Goldwasser, F. (2008). Acute exacerbation of hemorrhagic rectocolitis during antiangiogenic therapy with sunitinib and sorafenib. Ann Oncol 19: 1975-1975 [Full Text]  
• Sleijfer, S., van der Graaf, W. T.A., Blay, J.-Y. (2008). Angiogenesis Inhibition in Non-GIST Soft Tissue Sarcomas. The Oncologist 13: 1193-1200 [Abstract] [Full Text]  
• Eisen, T., Oudard, S., Szczylik, C., Gravis, G., Heinzer, H., Middleton, R., Cihon, F., Anderson, S., Shah, S., Bukowski, R., Escudier, B., for the TARGET Study Group, (2008). Sorafenib for Older Patients With Renal Cell Carcinoma: Subset Analysis From a Randomized Trial. JNCI J Natl Cancer Inst 100: 1454-1463 [Abstract] [Full Text]  
• Ellis, L. M., Hicklin, D. J. (2008). Pathways Mediating Resistance to Vascular Endothelial Growth Factor-Targeted Therapy. Clin. Cancer Res. 14: 6371-6375 [Abstract] [Full Text]  
• Gupta-Abramson, V., Troxel, A. B., Nellore, A., Puttaswamy, K., Redlinger, M., Ransone, K., Mandel, S. J., Flaherty, K. T., Loevner, L. A., O'Dwyer, P. J., Brose, M. S. (2008). Phase II Trial of Sorafenib in Advanced Thyroid Cancer. JCO 26: 4714-4719 [Abstract] [Full Text]  
• Hahn, O. M., Yang, C., Medved, M., Karczmar, G., Kistner, E., Karrison, T., Manchen, E., Mitchell, M., Ratain, M. J., Stadler, W. M. (2008). Dynamic Contrast-Enhanced Magnetic Resonance Imaging Pharmacodynamic Biomarker Study of Sorafenib in Metastatic Renal Carcinoma. JCO 26: 4572-4578 [Abstract] [Full Text]  
• 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]  
• Wilhelm, S. M., Adnane, L., Newell, P., Villanueva, A., Llovet, J. M., Lynch, M. (2008). Preclinical overview of sorafenib, a multikinase inhibitor that targets both Raf and VEGF and PDGF receptor tyrosine kinase signaling. Molecular Cancer Therapeutics 7: 3129-3140 [Abstract] [Full Text]  
• Stein, W. D., Yang, J., Bates, S. E., Fojo, T. (2008). Bevacizumab Reduces the Growth Rate Constants of Renal Carcinomas: A Novel Algorithm Suggests Early Discontinuation of Bevacizumab Resulted in a Lack of Survival Advantage. The Oncologist 13: 1055-1062 [Abstract] [Full Text]  
• Hutson, T. E., Figlin, R. A., Kuhn, J. G., Motzer, R. J. (2008). Targeted Therapies for Metastatic Renal Cell Carcinoma: An Overview of Toxicity and Dosing Strategies. The Oncologist 13: 1084-1096 [Abstract] [Full Text]  
• Willmann, J. K., Lutz, A. M., Paulmurugan, R., Patel, M. R., Chu, P., Rosenberg, J., Gambhir, S. S. (2008). Dual-targeted Contrast Agent for US Assessment of Tumor Angiogenesis in Vivo. Radiology 248: 936-944 [Abstract] [Full Text]  
• 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]  
• Jiang, Z., Chu, P. G., Woda, B. A., Liu, Q., Balaji, K.C., Rock, K. L., Wu, C.-L. (2008). Combination of Quantitative IMP3 and Tumor Stage: A New System to Predict Metastasis for Patients with Localized Renal Cell Carcinomas. Clin. Cancer Res. 14: 5579-5584 [Abstract] [Full Text]  
• 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]  
• Bellmunt, J., Szczylik, C., Feingold, J., Strahs, A., Berkenblit, A. (2008). Temsirolimus safety profile and management of toxic effects in patients with advanced renal cell carcinoma and poor prognostic features. Ann Oncol 19: 1387-1392 [Abstract] [Full Text]  
• Negrier, S. (2008). Temsirolimus in metastatic renal cell carcinoma. Ann Oncol 19: 1369-1370 [Full Text]  
• Nickerson, M. L., Jaeger, E., Shi, Y., Durocher, J. A., Mahurkar, S., Zaridze, D., Matveev, V., Janout, V., Kollarova, H., Bencko, V., Navratilova, M., Szeszenia-Dabrowska, N., Mates, D., Mukeria, A., Holcatova, I., Schmidt, L. S., Toro, J. R., Karami, S., Hung, R., Gerard, G. F., Linehan, W. M., Merino, M., Zbar, B., Boffetta, P., Brennan, P., Rothman, N., Chow, W.-H., Waldman, F. M., Moore, L. E. (2008). Improved Identification of von Hippel-Lindau Gene Alterations in Clear Cell Renal Tumors. Clin. Cancer Res. 14: 4726-4734 [Abstract] [Full Text]