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Originally published as JCO Early Release 10.1200/JCO.2005.03.6723 on April 24 2006

Journal of Clinical Oncology, Vol 24, No 16 (June 1), 2006: pp. 2505-2512
© 2006 American Society of Clinical Oncology.
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Phase II Placebo-Controlled Randomized Discontinuation Trial of Sorafenib in Patients With Metastatic Renal Cell Carcinoma

Mark J. Ratain, Tim Eisen, Walter M. Stadler, Keith T. Flaherty, Stan B. Kaye, Gary L. Rosner, Martin Gore, Apurva A. Desai, Amita Patnaik, Henry Q. Xiong, Eric Rowinsky, James L. Abbruzzese, Chenghua Xia, Ronit Simantov, Brian Schwartz, Peter J. O'Dwyer

From the University of Chicago, Chicago, IL; Royal Marsden Hospital, Surrey, United Kingdom; Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA; The University of Texas M.D. Anderson Cancer Center, Houston; Cancer Therapy and Research Center, San Antonio, TX; Bayer Pharmaceuticals Corporation, West Haven, CT

Address reprint requests to Mark J. Ratain, MD, University of Chicago, 5841 S Maryland Ave, MC2115, Chicago, IL 60637; e-mail: mratain{at}medicine.bsd.uchicago.edu

PURPOSE: This phase II randomized discontinuation trial evaluated the effects of sorafenib (BAY 43-9006), an oral multikinase inhibitor targeting the tumor and vasculature, on tumor growth in patients with metastatic renal cell carcinoma.

PATIENTS AND METHODS: Patients initially received oral sorafenib 400 mg twice daily during the initial run-in period. After 12 weeks, patients with changes in bidimensional tumor measurements that were less than 25% from baseline were randomly assigned to sorafenib or placebo for an additional 12 weeks; patients with ≥ 25% tumor shrinkage continued open-label sorafenib; patients with ≥ 25% tumor growth discontinued treatment. The primary end point was the percentage of randomly assigned patients remaining progression free at 24 weeks after the initiation of sorafenib.

RESULTS: Of 202 patients treated during the run-in period, 73 patients had tumor shrinkage of ≥ 25%. Sixty-five patients with stable disease at 12 weeks were randomly assigned to sorafenib (n = 32) or placebo (n = 33). At 24 weeks, 50% of the sorafenib-treated patients were progression free versus 18% of the placebo-treated patients (P = .0077). Median progression-free survival (PFS) from randomization was significantly longer with sorafenib (24 weeks) than placebo (6 weeks; P = .0087). Median overall PFS was 29 weeks for the entire renal cell carcinoma population (n = 202). Sorafenib was readministered in 28 patients whose disease progressed on placebo; these patients continued on sorafenib until further progression, for a median of 24 weeks. Common adverse events were skin rash/desquamation, hand-foot skin reaction, and fatigue; 9% of patients discontinued therapy, and no patients died from toxicity.

CONCLUSION: Sorafenib has significant disease-stabilizing activity in metastatic renal cell carcinoma and is tolerable with chronic daily therapy.

Supported by Bayer Pharmaceuticals Corporation and Onyx Pharmaceuticals.

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


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Phase II Trial of Sorafenib in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck or Nasopharyngeal Carcinoma
J. Clin. Oncol., August 20, 2007; 25(24): 3766 - 3773.
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G. Bratslavsky, S. Sudarshan, L. Neckers, and W. M. Linehan
Pseudohypoxic Pathways in Renal Cell Carcinoma
Clin. Cancer Res., August 15, 2007; 13(16): 4667 - 4671.
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I. Duran, S. J. Hotte, H. Hirte, E. X. Chen, M. MacLean, S. Turner, L. Duan, G. R. Pond, C. Lathia, S. Walsh, et al.
Phase I Targeted Combination Trial of Sorafenib and Erlotinib in Patients with Advanced Solid Tumors
Clin. Cancer Res., August 15, 2007; 13(16): 4849 - 4857.
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J. A. Gollob, W. K. Rathmell, T. M. Richmond, C. B. Marino, E. K. Miller, G. Grigson, C. Watkins, L. Gu, B. L. Peterson, and J. J. Wright
Phase II Trial of Sorafenib Plus Interferon Alfa-2b As First- or Second-Line Therapy in Patients With Metastatic Renal Cell Cancer
J. Clin. Oncol., August 1, 2007; 25(22): 3288 - 3295.
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C. W. Ryan, B. H. Goldman, P. N. Lara Jr, P. C. Mack, T. M. Beer, C. M. Tangen, D. Lemmon, C.-X. Pan, H. A. Drabkin, and E. D. Crawford
Sorafenib With Interferon Alfa-2b As First-Line Treatment of Advanced Renal Carcinoma: A Phase II Study of the Southwest Oncology Group
J. Clin. Oncol., August 1, 2007; 25(22): 3296 - 3301.
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S Hariharan, D Gustafson, S Holden, D McConkey, D Davis, M Morrow, M Basche, L Gore, C Zang, C. O'Bryant, et al.
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. Onc., August 1, 2007; 18(8): 1400 - 1407.
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 Mol. Cell. Biol.Home page
M. Rahmani, E. M. Davis, T. R. Crabtree, J. R. Habibi, T. K. Nguyen, P. Dent, and S. Grant
The Kinase Inhibitor Sorafenib Induces Cell Death through a Process Involving Induction of Endoplasmic Reticulum Stress
Mol. Cell. Biol., August 1, 2007; 27(15): 5499 - 5513.
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N. Griffin, M. E. Gore, and S. A. Sohaib
Imaging in Metastatic Renal Cell Carcinoma
Am. J. Roentgenol., August 1, 2007; 189(2): 360 - 370.
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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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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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B. Chabner
Phase II Cancer Trials: Out of Control?
Clin. Cancer Res., April 15, 2007; 13(8): 2307 - 2308.
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L. C. Michaelis and M. J. Ratain
Phase II Trials Published in 2002: A Cross-Specialty Comparison Showing Significant Design Differences between Oncology Trials and Other Medical Specialties
Clin. Cancer Res., April 15, 2007; 13(8): 2400 - 2405.
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R. L. Schilsky
Target practice: oncology drug development in the era of genomic medicine
Clinical Trials, April 1, 2007; 4(2): 163 - 166.
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 Molecular Cancer TherapeuticsHome page
W. M. Stadler
The randomized discontinuation trial: a phase II design to assess growth-inhibitory agents
Mol. Cancer Ther., April 1, 2007; 6(4): 1180 - 1185.
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 The OncologistHome page
D. Strumberg, J. W. Clark, A. Awada, M. J. Moore, H. Richly, A. Hendlisz, H. W. Hirte, J. P. Eder, H.-J. Lenz, and B. Schwartz
Safety, Pharmacokinetics, and Preliminary Antitumor Activity of Sorafenib: A Review of Four Phase I Trials in Patients with Advanced Refractory Solid Tumors
Oncologist, April 1, 2007; 12(4): 426 - 437.
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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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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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H. M. Kantarjian, F. Giles, A. Quintas-Cardama, and J. Cortes
Important Therapeutic Targets in Chronic Myelogenous Leukemia
Clin. Cancer Res., February 15, 2007; 13(4): 1089 - 1097.
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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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 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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 Clin. Cancer Res.Home page
M. A. Rosen and M. D. Schnall
Dynamic Contrast-Enhanced Magnetic Resonance Imaging for Assessing Tumor Vascularity and Vascular Effects of Targeted Therapies in Renal Cell Carcinoma
Clin. Cancer Res., January 15, 2007; 13(2): 770s - 776s.
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 NEJMHome page
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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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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 Clin. Cancer Res.Home page
P. H. Patel, R. S.V. Chadalavada, R.S.K. Chaganti, and R. J. Motzer
Targeting von Hippel-Lindau Pathway in Renal Cell Carcinoma
Clin. Cancer Res., December 15, 2006; 12(24): 7215 - 7220.
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R. C. Kane, A. T. Farrell, H. Saber, S. Tang, G. Williams, J. M. Jee, C. Liang, B. Booth, N. Chidambaram, D. Morse, et al.
Sorafenib for the Treatment of Advanced Renal Cell Carcinoma
Clin. Cancer Res., December 15, 2006; 12(24): 7271 - 7278.
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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.
[Abstract] [Full Text] [PDF]

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R. Govindarajan, J. Adusumilli, D. L. Baxter, A. El-Khoueiry, and S. I. Harik
Reversible Posterior Leukoencephalopathy Syndrome Induced by RAF Kinase Inhibitor BAY 43-9006
J. Clin. Oncol., October 1, 2006; 24(28): e48 - e48.
[Full Text] [PDF]

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M. J. Ratain
In Reply
J. Clin. Oncol., October 1, 2006; 24(28): 4670 - 4671.
[Full Text] [PDF]

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G. Sonpavde, T. E. Hutson, M. D. Galsky, and W. R. Berry
Problems With the Randomized Discontinuation Design
J. Clin. Oncol., October 1, 2006; 24(28): 4669a - 4670.
[Full Text] [PDF]


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