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Originally published as JCO Early Release 10.1200/JCO.2005.08.037 on January 27 2005

Journal of Clinical Oncology, Vol 23, No 9 (March 20), 2005: pp. 1803-1810
© 2005 American Society of Clinical Oncology.
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Cetuximab Shows Activity in Colorectal Cancer Patients With Tumors That Do Not Express the Epidermal Growth Factor Receptor by Immunohistochemistry

Ki Young Chung, Jinru Shia, Nancy E. Kemeny, Manish Shah, Gary K. Schwartz, Archie Tse, Audrey Hamilton, Dorothy Pan, Deborah Schrag, Lawrence Schwartz, David S. Klimstra, Daniel Fridman, David P. Kelsen, Leonard B. Saltz

From the Gastrointestinal Oncology Service and Departments of Medicine, Pathology, and Diagnostic Imaging, Memorial Sloan-Kettering Cancer Center, New York, NY

Address reprint requests to Ki Young Chung, MD, Gastrointestinal Oncology Service, Memorial Sloan-Kettering Cancer Center, H-816, New York, NY 10021; e-mail: chungk{at}mskcc.org

PURPOSE: To establish evidence of activity, or lack thereof, of cetuximab-based therapy in patients with refractory colorectal cancer with tumors that do not demonstrate epidermal growth factor receptor (EGFR) expression by immunohistochemistry (IHC).

PATIENTS AND METHODS: Pharmacy computer records were reviewed to identify all patients who received cetuximab at Memorial Sloan-Kettering Cancer Center in a nonstudy setting during the first 3 months of cetuximab's commercial availability. Medical records of these patients were then reviewed to identify colorectal cancer patients who had experienced failure with a prior irinotecan-based regimen and who had a pathology report indicating an EGFR-negative tumor by IHC. Pathology slides from these patients were reviewed by a reference pathologist to confirm EGFR negativity, and computed tomography scans during cetuximab-based therapy were reviewed by a reference radiologist. Response rates were reported using WHO criteria.

RESULTS: Sixteen chemotherapy-refractory, EGFR-negative colorectal cancer patients who received cetuximab in a nonstudy setting were identified. Fourteen of these patients received cetuximab plus irinotecan, and two received cetuximab monotherapy. In the 16 patients, four major objective responses were seen (response rate, 25%; 95% CI, 4% to 46%).

CONCLUSION: Colorectal cancer patients with EGFR-negative tumors have the potential to respond to cetuximab-based therapies. EGFR analysis by current IHC techniques does not seem to have predictive value, and selection or exclusion of patients for cetuximab therapy on the basis of currently available EGFR IHC does not seem warranted.

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


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  • Epidermal Growth Factor Receptor Inhibitors in Colorectal Cancer: It's Time to Get Back on Target
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J. B. Vermorken, J. Trigo, R. Hitt, P. Koralewski, E. Diaz-Rubio, F. Rolland, R. Knecht, N. Amellal, A. Schueler, and J. Baselga
Open-Label, Uncontrolled, Multicenter Phase II Study to Evaluate the Efficacy and Toxicity of Cetuximab As a Single Agent in Patients With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Failed to Respond to Platinum-Based Therapy
J. Clin. Oncol., June 1, 2007; 25(16): 2171 - 2177.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
C. Larbouret, B. Robert, I. Navarro-Teulon, S. Thezenas, M.-Z. Ladjemi, S. Morisseau, E. Campigna, F. Bibeau, J.-P. Mach, A. Pelegrin, et al.
In vivo Therapeutic Synergism of Anti-Epidermal Growth Factor Receptor and Anti-HER2 Monoclonal Antibodies against Pancreatic Carcinomas
Clin. Cancer Res., June 1, 2007; 13(11): 3356 - 3362.
[Abstract] [Full Text] [PDF]

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 Clin TrialsHome page
R. L. Schilsky
Target practice: oncology drug development in the era of genomic medicine
Clinical Trials, April 1, 2007; 4(2): 163 - 166.
[PDF]

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 Clin TrialsHome page
L. Norton
Discussion
Clinical Trials, April 1, 2007; 4(2): 173 - 175.
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 Clin. Cancer Res.Home page
T. G. Johns, R. M. Perera, S. C. Vernes, A. A. Vitali, D. X. Cao, W. K. Cavenee, A. M. Scott, and F. B. Furnari
The Efficacy of Epidermal Growth Factor Receptor-Specific Antibodies against Glioma Xenografts Is Influenced by Receptor Levels, Activation Status, and Heterodimerization
Clin. Cancer Res., March 15, 2007; 13(6): 1911 - 1925.
[Abstract] [Full Text] [PDF]

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 JCOHome page
T. Dragovich and C. Fenoglio-Preiser
In Reply
J. Clin. Oncol., March 1, 2007; 25(7): 911 - 911.
[Full Text] [PDF]

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 Ann OncolHome page
J. Cruz, A Ocana, E Del Barco, and A Pandiella
Targeting receptor tyrosine kinases and their signal transduction routes in head and neck cancer
Ann. Onc., March 1, 2007; 18(3): 421 - 430.
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 Clin. Cancer Res.Home page
J. Kurai, H. Chikumi, K. Hashimoto, K. Yamaguchi, A. Yamasaki, T. Sako, H. Touge, H. Makino, M. Takata, M. Miyata, et al.
Antibody-Dependent Cellular Cytotoxicity Mediated by Cetuximab against Lung Cancer Cell Lines
Clin. Cancer Res., March 1, 2007; 13(5): 1552 - 1561.
[Abstract] [Full Text] [PDF]

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 Molecular Cancer TherapeuticsHome page
E. Buck, A. Eyzaguirre, S. Barr, S. Thompson, R. Sennello, D. Young, K. K. Iwata, N. W. Gibson, P. Cagnoni, and J. D. Haley
Loss of homotypic cell adhesion by epithelial-mesenchymal transition or mutation limits sensitivity to epidermal growth factor receptor inhibition
Mol. Cancer Ther., February 1, 2007; 6(2): 532 - 541.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
J Souglakos, A Kalykaki, L Vamvakas, N Androulakis, K Kalbakis, S Agelaki, N Vardakis, M Tzardi, A. Kotsakis, J Gioulbasanis, et al.
Phase II trial of capecitabine and oxaliplatin (CAPOX) plus cetuximab in patients with metastatic colorectal cancer who progressed after oxaliplatin-based chemotherapy
Ann. Onc., February 1, 2007; 18(2): 305 - 310.
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 JCOHome page
D. B. Solit and N. Rosen
Targeting HER2 in Prostate Cancer: Where to Next?
J. Clin. Oncol., January 20, 2007; 25(3): 241 - 243.
[Full Text] [PDF]

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 Mayo Clin Proc.Home page
S. Gill, A. W. Blackstock, and R. M. Goldberg
Colorectal Cancer
Mayo Clin. Proc., January 1, 2007; 82(1): 114 - 129.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
M-C Etienne-Grimaldi, A Cayre, F Penault-Llorca, M Francoual, J-L Formento, D Benchimol, A Bourgeon, and G Milano
EGFR expression in colon cancer: a break in the clouds
Ann. Onc., December 1, 2006; 17(12): 1850 - 1851.
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 Clin. Cancer Res.Home page
A. R. Tan, D. F. Moore, M. Hidalgo, J. H. Doroshow, E. A. Poplin, S. Goodin, D. Mauro, and E. H. Rubin
Pharmacokinetics of Cetuximab After Administration of Escalating Single Dosing and Weekly Fixed Dosing in Patients with Solid Tumors
Clin. Cancer Res., November 1, 2006; 12(21): 6517 - 6522.
[Abstract] [Full Text] [PDF]

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 JCOHome page
H.-J. Lenz, E. Van Cutsem, S. Khambata-Ford, R. J. Mayer, P. Gold, P. Stella, B. Mirtsching, A. L. Cohn, A. W. Pippas, N. Azarnia, et al.
Multicenter Phase II and Translational Study of Cetuximab in Metastatic Colorectal Carcinoma Refractory to Irinotecan, Oxaliplatin, and Fluoropyrimidines
J. Clin. Oncol., October 20, 2006; 24(30): 4914 - 4921.
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 Clin. Cancer Res.Home page
H. M. Linden, K. A. Krohn, R. B. Livingston, and D. A. Mankoff
Monitoring targeted therapy: is fluorodeoxylucose uptake a marker of early response?
Clin. Cancer Res., October 1, 2006; 12(19): 5608 - 5610.
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 The OncologistHome page
E. Van Cutsem
Challenges in the Use of Epidermal Growth Factor Receptor Inhibitors in Colorectal Cancer
Oncologist, October 1, 2006; 11(9): 1010 - 1017.
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 Cancer Res.Home page
M. P. Cunningham, H. Thomas, Z. Fan, and H. Modjtahedi
Responses of Human Colorectal Tumor Cells to Treatment with the Anti-Epidermal Growth Factor Receptor Monoclonal Antibody ICR62 Used Alone and in Combination with the EGFR Tyrosine Kinase Inhibitor Gefitinib.
Cancer Res., August 1, 2006; 66(15): 7708 - 7715.
[Abstract] [Full Text] [PDF]

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 J Oncol Pharm PractHome page
M Milano and O Guerin
Recent advances in targeted therapies for colorectal cancer
Journal of Oncology Pharmacy Practice, June 1, 2006; 12(2): 69 - 73.
[Abstract] [PDF]

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 Ann OncolHome page
M. Francoual, M.-C. Etienne-Grimaldi, J.-L. Formento, D. Benchimol, A. Bourgeon, M. Chazal, C. Letoublon, T. Andre, N. Gilly, J.-R. Delpero, et al.
EGFR in colorectal cancer: more than a simple receptor
Ann. Onc., June 1, 2006; 17(6): 962 - 967.
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{blacktriangledown}Bevacizumab and {blacktriangledown}cetuximab for colorectal cancer
DTB, May 1, 2006; 44(5): 37 - 40.
[Abstract] [Full Text] [PDF]

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 Am J Health Syst PharmHome page
K. R. Crews
Individualizing chemotherapeutic treatment of colorectal cancer
Am. J. Health Syst. Pharm., May 1, 2006; 63(9_Supplement_2): S12 - S17.
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J. A. Meyerhardt, A. X. Zhu, P. C. Enzinger, D. P. Ryan, J. W. Clark, M. H. Kulke, C. C. Earle, M. Vincitore, A. Michelini, S. Sheehan, et al.
Phase II Study of Capecitabine, Oxaliplatin, and Erlotinib in Previously Treated Patients With Metastastic Colorectal Cancer
J. Clin. Oncol., April 20, 2006; 24(12): 1892 - 1897.
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B. Vincenzi, D. Santini, and G. Tonini
New Issues on Cetuximab Mechanism of Action in Epidermal Growth Factor Receptor-Negative Colorectal Cancer: The Role of Vascular Endothelial Growth Factor
J. Clin. Oncol., April 20, 2006; 24(12): 1957 - 1957.
[Full Text] [PDF]

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K. Y. Chung and L. B. Saltz
In Reply:
J. Clin. Oncol., April 20, 2006; 24(12): 1957 - 1958.
[Full Text] [PDF]

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A. Lievre, J.-B. Bachet, D. Le Corre, V. Boige, B. Landi, J.-F. Emile, J.-F. Cote, G. Tomasic, C. Penna, M. Ducreux, et al.
KRAS Mutation Status Is Predictive of Response to Cetuximab Therapy in Colorectal Cancer.
Cancer Res., April 15, 2006; 66(8): 3992 - 3995.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
D. S. Ettinger
Clinical Implications of EGFR Expression in the Development and Progression of Solid Tumors: Focus on Non-Small Cell Lung Cancer.
Oncologist, April 1, 2006; 11(4): 358 - 373.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
A. Kong, P. Leboucher, R. Leek, V. Calleja, S. Winter, A. Harris, P. J. Parker, and B. Larijani
Prognostic value of an activation state marker for epidermal growth factor receptor in tissue microarrays of head and neck cancer.
Cancer Res., March 1, 2006; 66(5): 2834 - 2843.
[Abstract] [Full Text] [PDF]

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 Ann OncolHome page
G. Folprecht, M. P. Lutz, P. Schoffski, T. Seufferlein, A. Nolting, P. Pollert, and C.-H. Kohne
Cetuximab and irinotecan/5-fluorouracil/folinic acid is a safe combination for the first-line treatment of patients with epidermal growth factor receptor expressing metastatic colorectal carcinoma
Ann. Onc., March 1, 2006; 17(3): 450 - 456.
[Abstract] [Full Text] [PDF]

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 Cancer Res.Home page
D. N. Amin, K. Hida, D. R. Bielenberg, and M. Klagsbrun
Tumor Endothelial Cells Express Epidermal Growth Factor Receptor (EGFR) but not ErbB3 and Are Responsive to EGF and to EGFR Kinase Inhibitors
Cancer Res., February 15, 2006; 66(4): 2173 - 2180.
[Abstract] [Full Text] [PDF]

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 The Annals of PharmacotherapyHome page
D. A Frieze and J. S McCune
Current Status of Cetuximab for the Treatment of Patients with Solid Tumors
Ann. Pharmacother., February 1, 2006; 40(2): 241 - 250.
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