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Originally published as JCO Early Release 10.1200/JCO.2005.02.2574 on December 5 2005

Journal of Clinical Oncology, Vol 24, No 1 (January 1), 2006: pp. 16-24
© 2006 American Society of Clinical Oncology.
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Activity of SU11248, a Multitargeted Inhibitor of Vascular Endothelial Growth Factor Receptor and Platelet-Derived Growth Factor Receptor, in Patients With Metastatic Renal Cell Carcinoma

Robert J. Motzer, M. Dror Michaelson, Bruce G. Redman, Gary R. Hudes, George Wilding, Robert A. Figlin, Michelle S. Ginsberg, Sindy T. Kim, Charles M. Baum, Samuel E. DePrimo, Jim Z. Li, Carlo L. Bello, Charles P. Theuer, Daniel J. George, Brian I. Rini

From the Genitourinary Oncology Service, Division of Solid Tumor Oncology, Departments of Medicine and Radiology, Memorial Sloan-Kettering Cancer Center, New York, NY; Massachusetts General Hospital; Dana-Farber Cancer Institute, Boston, MA; University of Michigan, Ann Arbor, MI; Fox Chase Cancer Center, Philadelphia, PA; University of Wisconsin, Madison, WI; University of California Los Angeles, Los Angeles; Pfizer Inc, La Jolla; and University of California San Francisco, San Francisco, CA

Address reprint requests to Robert Motzer, MD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021; e-mail: motzerr{at}mskcc.org

PURPOSE: Renal cell carcinoma (RCC) is characterized by loss of von Hippel Lindau tumor suppressor gene activity, resulting in high expression of pro-angiogenic growth factors: vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF). SU11248 (sunitinib malate), a small molecule inhibitor with high binding affinity for VEGF and PDGF receptors, was tested for clinical activity in patients with metastatic RCC.

PATIENTS AND METHODS: Patients with metastatic RCC and progression on first-line cytokine therapy were enrolled onto a multicenter phase II trial. SU11248 monotherapy was administered in repeated 6-week cycles of daily oral therapy for 4 weeks, followed by 2 weeks off. Overall response rate was the primary end point, and time to progression and safety were secondary end points.

RESULTS: Twenty-five (40%) of 63 patients treated with SU11248 achieved partial responses; 17 additional patients (27%) demonstrated stable disease lasting ≥ 3 months. Median time to progression in the 63 patients was 8.7 months. Dosing was generally tolerated with manageable toxicities.

CONCLUSION: SU11248, a multitargeted receptor tyrosine kinase inhibitor of VEGF and PDGF receptors, demonstrates antitumor activity in metastatic RCC as second-line therapy, a setting where no effective systemic therapy is presently recognized. The genetics of RCC and these promising clinical results support the hypothesis that VEGF and PDGF receptor-mediated signaling is an effective therapeutic target in RCC.

Supported by Pfizer Inc, La Jolla, CA.

Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, June 5-8, 2004, New Orleans, LA.

D.J.G. and B.I.R. contributed equally to the study.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.


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Sunitinib Malate and Multiple Receptor Tyrosine Kinases Inhibitors: Are They Also Novel Drugs for Chronic and Neurophatic Pain?
J. Clin. Oncol., July 1, 2007; 25(19): 2858 - 2859.
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J Medioni, O Cojocarasu, J-L Belcaceres, P Halimi, and S Oudard
Complete cerebral response with sunitinib for metastatic renal cell carcinoma
Ann. Onc., July 1, 2007; 18(7): 1282 - 1283.
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R. Kumar, V. B. Knick, S. K. Rudolph, J. H. Johnson, R. M. Crosby, M.-C. Crouthamel, T. M. Hopper, C. G. Miller, L. E. Harrington, J. A. Onori, et al.
Pharmacokinetic-pharmacodynamic correlation from mouse to human with pazopanib, a multikinase angiogenesis inhibitor with potent antitumor and antiangiogenic activity
Mol. Cancer Ther., July 1, 2007; 6(7): 2012 - 2021.
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M. N. Stein and K. T. Flaherty
CCR Drug Updates: Sorafenib and Sunitinib in Renal Cell Carcinoma
Clin. Cancer Res., July 1, 2007; 13(13): 3765 - 3770.
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O Rixe, B Billemont, and H Izzedine
Hypertension as a predictive factor of Sunitinib activity
Ann. Onc., June 1, 2007; 18(6): 1117 - 1117.
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H. Choi, C. Charnsangavej, S. C. Faria, H. A. Macapinlac, M. A. Burgess, S. R. Patel, L. L. Chen, D. A. Podoloff, and R. S. Benjamin
Correlation of Computed Tomography and Positron Emission Tomography in Patients With Metastatic Gastrointestinal Stromal Tumor Treated at a Single Institution With Imatinib Mesylate: Proposal of New Computed Tomography Response Criteria
J. Clin. Oncol., May 1, 2007; 25(13): 1753 - 1759.
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R. S. Benjamin, H. Choi, H. A. Macapinlac, M. A. Burgess, S. R. Patel, L. L. Chen, D. A. Podoloff, and C. Charnsangavej
We Should Desist Using RECIST, at Least in GIST
J. Clin. Oncol., May 1, 2007; 25(13): 1760 - 1764.
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F. Loupakis, A. Falcone, G. Masi, A. Fioravanti, R. S. Kerbel, M. Del Tacca, and G. Bocci
Vascular Endothelial Growth Factor Levels in Immunodepleted Plasma of Cancer Patients As a Possible Pharmacodynamic Marker for Bevacizumab Activity
J. Clin. Oncol., May 1, 2007; 25(13): 1816 - 1818.
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 Cancer Res.Home page
P. S. Bachmann, R. Gorman, R. A. Papa, J. E. Bardell, J. Ford, U. R. Kees, G. M. Marshall, and R. B. Lock
Divergent Mechanisms of Glucocorticoid Resistance in Experimental Models of Pediatric Acute Lymphoblastic Leukemia
Cancer Res., May 1, 2007; 67(9): 4482 - 4490.
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A. Norden-Zfoni, J. Desai, J. Manola, P. Beaudry, J. Force, R. Maki, J. Folkman, C. Bello, C. Baum, S. E. DePrimo, et al.
Blood-Based Biomarkers of SU11248 Activity and Clinical Outcome in Patients with Metastatic Imatinib-Resistant Gastrointestinal Stromal Tumor
Clin. Cancer Res., May 1, 2007; 13(9): 2643 - 2650.
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M. J. Morris, N. Pandit-Taskar, C. R. Divgi, S. Bender, J. A. O'Donoghue, A. Nacca, P. Smith-Jones, L. Schwartz, S. Slovin, R. Finn, et al.
Phase I Evaluation of J591 as a Vascular Targeting Agent in Progressive Solid Tumors
Clin. Cancer Res., May 1, 2007; 13(9): 2707 - 2713.
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A. Haferkamp and M. Hohenfellner
Medical treatment options in patients with metastatic renal cell carcinoma
Nephrol. Dial. Transplant., April 1, 2007; 22(4): 996 - 999.
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G. Giaccone
The Potential of Antiangiogenic Therapy in Non-Small Cell Lung Cancer
Clin. Cancer Res., April 1, 2007; 13(7): 1961 - 1970.
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S. N. Markovic, L. A. Erickson, R. D. Rao, R. H. Weenig, B. A. Pockaj, A. Bardia, C. M. Vachon, S. E. Schild, R. R. McWilliams, J. L. Hand, et al.
Malignant Melanoma in the 21st Century, Part 2: Staging, Prognosis, and Treatment
Mayo Clin. Proc., April 1, 2007; 82(4): 490 - 513.
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W. Stadler
Chromosomes, Hypoxia, Angiogenesis, and Trial Design: A Brief History of Renal Cancer Drug Development
Clin. Cancer Res., March 15, 2007; 13(6): 1630 - 1633.
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L. Q.M. Chow and S. G. Eckhardt
Sunitinib: From Rational Design to Clinical Efficacy
J. Clin. Oncol., March 1, 2007; 25(7): 884 - 896.
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J. A. Garcia and B. I. Rini
Recent Progress in the Management of Advanced Renal Cell Carcinoma
CA Cancer J Clin, March 1, 2007; 57(2): 112 - 125.
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J. Tabernero
The Role of VEGF and EGFR Inhibition: Implications for Combining Anti-VEGF and Anti-EGFR Agents
Mol. Cancer Res., March 1, 2007; 5(3): 203 - 220.
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B. I. Rini
Vascular Endothelial Growth Factor-Targeted Therapy in Renal Cell Carcinoma: Current Status and Future Directions
Clin. Cancer Res., February 15, 2007; 13(4): 1098 - 1106.
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N. Steeghs, J. W. R. Nortier, and H. Gelderblom
Small Molecule Tyrosine Kinase Inhibitors in the Treatment of Solid Tumors: An Update of Recent Developments
Ann. Surg. Oncol., February 1, 2007; 14(2): 942 - 953.
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M. Eto, M. Harano, K. Tatsugami, M. Harada, Y. Kamiryo, K. Kiyoshima, M. Hamaguchi, M. Tsuneyoshi, Y. Yoshikai, and S. Naito
Cyclophosphamide-Using Nonmyeloablative Allogeneic Cell Therapy against Renal Cancer with a Reduced Risk of Graft-versus-Host Disease
Clin. Cancer Res., February 1, 2007; 13(3): 1029 - 1035.
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 The OncologistHome page
C. Gridelli, P. Maione, F. Del Gaizo, G. Colantuoni, C. Guerriero, C. Ferrara, D. Nicolella, D. Comunale, A. De Vita, and A. Rossi
Sorafenib and Sunitinib in the Treatment of Advanced Non-Small Cell Lung Cancer
Oncologist, February 1, 2007; 12(2): 191 - 200.
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J. R. Infante, H. Matsubayashi, N. Sato, J. Tonascia, A. P. Klein, T. A. Riall, C. Yeo, C. Iacobuzio-Donahue, and M. Goggins
Peritumoral Fibroblast SPARC Expression and Patient Outcome With Resectable Pancreatic Adenocarcinoma
J. Clin. Oncol., January 20, 2007; 25(3): 319 - 325.
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M. B. Atkins, M. S. Ernstoff, R. A. Figlin, K. T. Flaherty, D. J. George, W. G. Kaelin Jr., E. D. Kwon, T. A. Libermann, W. M. Linehan, D. F. McDermott, et al.
Innovations and Challenges in Renal Cell Carcinoma: Summary Statement from the Second Cambridge Conference
Clin. Cancer Res., January 15, 2007; 13(2): 667s - 670s.
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W. M. Linehan, P. A. Pinto, R. Srinivasan, M. Merino, P. Choyke, L. Choyke, J. Coleman, J. Toro, G. Glenn, C. Vocke, et al.
Identification of the Genes for Kidney Cancer: Opportunity for Disease-Specific Targeted Therapeutics
Clin. Cancer Res., January 15, 2007; 13(2): 671s - 679s.
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D. F. McDermott
Update on the Application of Interleukin-2 in the Treatment of Renal Cell Carcinoma
Clin. Cancer Res., January 15, 2007; 13(2): 716s - 720s.
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M. S. Ernstoff, T. S. Crocenzi, J. D. Seigne, N. A. Crosby, B. F. Cole, J. L. Fisher, J. C. Uhlenhake, D. Mellinger, C. Foster, C. J. Farnham, et al.
Developing a Rational Tumor Vaccine Therapy for Renal Cell Carcinoma: Immune Yin and Yang
Clin. Cancer Res., January 15, 2007; 13(2): 733s - 740s.
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D. J. George
Phase 2 Studies of Sunitinib and AG013736 in Patients with Cytokine-Refractory Renal Cell Carcinoma
Clin. Cancer Res., January 15, 2007; 13(2): 753s - 757s.
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R. S. Bhatt, P. Seth, and V. P. Sukhatme
Biomarkers for Monitoring Antiangiogenic Therapy
Clin. Cancer Res., January 15, 2007; 13(2): 777s - 780s.
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 NEJMHome page
R. J. Motzer, T. E. Hutson, P. Tomczak, M. D. Michaelson, R. M. Bukowski, O. Rixe, S. Oudard, S. Negrier, C. Szczylik, S. T. Kim, et al.
Sunitinib versus Interferon Alfa in Metastatic Renal-Cell Carcinoma
N. Engl. J. Med., January 11, 2007; 356(2): 115 - 124.
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B. Escudier, T. Eisen, W. M. Stadler, C. Szczylik, S. Oudard, M. Siebels, S. Negrier, C. Chevreau, E. Solska, A. A. Desai, et al.
Sorafenib in Advanced Clear-Cell Renal-Cell Carcinoma
N. Engl. J. Med., January 11, 2007; 356(2): 125 - 134.
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B. I. Rini, I. Tamaskar, P. Shaheen, R. Salas, J. Garcia, L. Wood, S. Reddy, R. Dreicer, and R. M. Bukowski
Hypothyroidism in Patients With Metastatic Renal Cell Carcinoma Treated With Sunitinib
J Natl Cancer Inst, January 3, 2007; 99(1): 81 - 83.
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X. Yao, C.-N. Qian, Z.-F. Zhang, M.-H. Tan, E. J. Kort, X. J. Yang, J. H. Resau, and B. T. Teh
Two Distinct Types of Blood Vessels in Clear Cell Renal Cell Carcinoma Have Contrasting Prognostic Implications
Clin. Cancer Res., January 1, 2007; 13(1): 161 - 169.
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 JCOHome page
M. Parton, M. Gore, and T. Eisen
Role of Cytokine Therapy in 2006 and Beyond for Metastatic Renal Cell Cancer
J. Clin. Oncol., December 10, 2006; 24(35): 5584 - 5592.
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R. J. Motzer and R. M. Bukowski
Targeted Therapy for Metastatic Renal Cell Carcinoma
J. Clin. Oncol., December 10, 2006; 24(35): 5601 - 5608.
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J. Desai, L. Yassa, E. Marqusee, S. George, M. C. Frates, M. H. Chen, J. A. Morgan, S. S. Dychter, P. R. Larsen, G. D. Demetri, et al.
Hypothyroidism after sunitinib treatment for patients with gastrointestinal stromal tumors.
Ann Intern Med, November 7, 2006; 145(9): 660 - 664.
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M. J. Ratain
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J. Clin. Oncol., October 1, 2006; 24(28): 4670 - 4671.
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D. W. Kim, Y. S. Jo, H. S. Jung, H. K. Chung, J. H. Song, K. C. Park, S. H. Park, J. H. Hwang, S. Y. Rha, G. R. Kweon, et al.
An Orally Administered Multitarget Tyrosine Kinase Inhibitor, SU11248, Is a Novel Potent Inhibitor of Thyroid Oncogenic RET/Papillary Thyroid Cancer Kinases
J. Clin. Endocrinol. Metab., October 1, 2006; 91(10): 4070 - 4076.
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R. H. Alvarez, H. M. Kantarjian, and J. E. Cortes
Biology of Platelet-Derived Growth Factor and Its Involvement in Disease
Mayo Clin. Proc., September 1, 2006; 81(9): 1241 - 1257.
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 JCOHome page
S. E. Eggener, O. Yossepowitch, J. A. Pettus, M. E. Snyder, R. J. Motzer, and P. Russo
Renal Cell Carcinoma Recurrence After Nephrectomy for Localized Disease: Predicting Survival From Time of Recurrence
J. Clin. Oncol., July 1, 2006; 24(19): 3101 - 3106.
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 Ann OncolHome page
L. Barkholt, M. Bregni, M. Remberger, D. Blaise, J. Peccatori, G. Massenkeil, P. Pedrazzoli, A. Zambelli, J.-O. Bay, S. Francois, et al.
Allogeneic haematopoietic stem cell transplantation for metastatic renal carcinoma in Europe
Ann. Onc., July 1, 2006; 17(7): 1134 - 1140.
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