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[Cancer Research 66, 3992-3995, April 15, 2006]
© 2006 American Association for Cancer Research

Priority Reports

KRAS Mutation Status Is Predictive of Response to Cetuximab Therapy in Colorectal Cancer

Astrid Lièvre1,3, Jean-Baptiste Bachet3, Delphine Le Corre1, Valérie Boige4, Bruno Landi2, Jean-François Emile3, Jean-François Côté1,2, Gorana Tomasic4, Christophe Penna3, Michel Ducreux4, Philippe Rougier3, Frédérique Penault-Llorca5 and Pierre Laurent-Puig1,2

1 Université Paris-Descartes, Institut National de la Sante et de la Recherche Medicale UMR-775; 2 Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France; 3 Assistance Publique-Hôpitaux de Paris, Hôpital Ambroise Paré, Boulogne Billancourt, France, Université de Versailles Saint-Quentin-en-Yvelines, Versailles, France; 4 Institut Gustave Roussy, Villejuif, France; and 5 Centre Jean Perrin, Clermont-Ferrand, France, Université Auvergne, Clermont-Ferrand, France

Requests for reprints: Pierre Laurent-Puig, Institut National de la Sante et de la Recherche Medicale U775, Molecular Basis of Response to Xenobiotics, 45 rue des Saints-Pères, 75006 Paris, France. Phone: 33-1-4286-2081; Fax: 33-1-4286-2072; E-mail: pierre.laurent-puig{at}univ-paris5.fr.

The anti-epidermal growth factor receptor (anti-EGFR) cetuximab has been proven to be efficient in metastatic colorectal cancer. The molecular mechanisms underlying the clinical response to this drug remain unknown. Genetic alterations of the intracellular effectors involved in EGFR-related signaling pathways may have an effect on response to this targeted therapy. In this study, tumors from 30 metastatic colorectal cancer patients treated by cetuximab were screened for KRAS, BRAF, and PIK3CA mutation by direct sequencing and for EGFR copy number by chromogenic in situ hybridization. Eleven of the 30 patients (37%) responded to cetuximab. A KRAS mutation was found in 13 tumors (43%) and was significantly associated with the absence of response to cetuximab (KRAS mutation in 0% of the 11 responder patients versus 68.4% of the 19 nonresponder patients; P = 0.0003). The overall survival of patients without KRAS mutation in their tumor was significantly higher compared with those patients with a mutated tumor (P = 0.016; median, 16.3 versus 6.9 months). An increased EGFR copy number was found in 3 patients (10%) and was significantly associated with an objective tumor response to cetuximab (P = 0.04). In conclusion, in this study, KRAS mutations are a predictor of resistance to cetuximab therapy and are associated with a worse prognosis. The EGFR amplification, which is not as frequent as initially reported, is also associated with response to this treatment. (Cancer Res 2006; 66(8): 3992-5)




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F. Ciardiello and G. Tortora
EGFR Antagonists in Cancer Treatment
N. Engl. J. Med., March 13, 2008; 358(11): 1160 - 1174.
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 Ann OncolHome page
W. De Roock, H. Piessevaux, J. De Schutter, M. Janssens, G. De Hertogh, N. Personeni, B. Biesmans, J.-L. Van Laethem, M. Peeters, Y. Humblet, et al.
KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab
Ann. Onc., March 1, 2008; 19(3): 508 - 515.
[Abstract] [Full Text] [PDF]

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 J. Mol. Diagn.Home page
F. Pinter, J. Papay, A. Almasi, Z. Sapi, E. Szabo, M. Kanya, A. Tamasi, B. Jori, E. Varkondi, J. Moldvay, et al.
Epidermal Growth Factor Receptor (EGFR) High Gene Copy Number and Activating Mutations in Lung Adenocarcinomas Are Not Consistently Accompanied by Positivity for EGFR Protein by Standard Immunohistochemistry
J. Mol. Diagn., March 1, 2008; 10(2): 160 - 168.
[Abstract] [Full Text] [PDF]

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 JCOHome page
A. Lievre, J.-B. Bachet, V. Boige, A. Cayre, D. Le Corre, E. Buc, M. Ychou, O. Bouche, B. Landi, C. Louvet, et al.
KRAS Mutations As an Independent Prognostic Factor in Patients With Advanced Colorectal Cancer Treated With Cetuximab
J. Clin. Oncol., January 20, 2008; 26(3): 374 - 379.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
L. M. Weiner, A. S. Belldegrun, J. Crawford, A. W. Tolcher, P. Lockbaum, R. H. Arends, L. Navale, R. G. Amado, G. Schwab, and R. A. Figlin
Dose and Schedule Study of Panitumumab Monotherapy in Patients with Advanced Solid Malignancies
Clin. Cancer Res., January 15, 2008; 14(2): 502 - 508.
[Abstract] [Full Text] [PDF]

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 JCOHome page
N. Normanno and A. De Luca
Erlotinib in Pancreatic Cancer: Are Tumor Cells the (only) Target?
J. Clin. Oncol., December 20, 2007; 25(36): 5836 - 5837.
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 Clin. Cancer Res.Home page
A. Grothey
Biological Therapy and Other Novel Therapies in Early-Stage Disease: Are They Appropriate?
Clin. Cancer Res., November 15, 2007; 13(22): 6909s - 6912s.
[Abstract] [Full Text] [PDF]

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 Jpn J Clin OncolHome page
R. H. Nakamoto, H. Uetake, S. Iida, Y. V. Kolev, L. T. Soumaoro, Y. Takagi, M. Yasuno, and K. Sugihara
Correlations between Cyclooxygenase-2 Expression and Angiogenic Factors in Primary Tumors and Liver Metastases in Colorectal Cancer
Jpn. J. Clin. Oncol., September 10, 2007; (2007) hym080v1.
[Abstract] [Full Text] [PDF]

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W. Zhang, M. Gordon, A. M. Schultheis, D. Y. Yang, F. Nagashima, M. Azuma, H.-M. Chang, E. Borucka, G. Lurje, A. E. Sherrod, et al.
FCGR2A and FCGR3A Polymorphisms Associated With Clinical Outcome of Epidermal Growth Factor Receptor Expressing Metastatic Colorectal Cancer Patients Treated With Single-Agent Cetuximab
J. Clin. Oncol., August 20, 2007; 25(24): 3712 - 3718.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
W. A. Messersmith and M. Hidalgo
Panitumumab, a Monoclonal Anti Epidermal Growth Factor Receptor Antibody in Colorectal Cancer: Another One or the One?
Clin. Cancer Res., August 15, 2007; 13(16): 4664 - 4666.
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 JCOHome page
S. Khambata-Ford, C. R. Garrett, N. J. Meropol, M. Basik, C. T. Harbison, S. Wu, T. W. Wong, X. Huang, C. H. Takimoto, A. K. Godwin, et al.
Expression of Epiregulin and Amphiregulin and K-ras Mutation Status Predict Disease Control in Metastatic Colorectal Cancer Patients Treated With Cetuximab
J. Clin. Oncol., August 1, 2007; 25(22): 3230 - 3237.
[Abstract] [Full Text] [PDF]

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A. Sartore-Bianchi, M. Moroni, S. Veronese, C. Carnaghi, E. Bajetta, G. Luppi, A. Sobrero, C. Barone, S. Cascinu, G. Colucci, et al.
Epidermal Growth Factor Receptor Gene Copy Number and Clinical Outcome of Metastatic Colorectal Cancer Treated With Panitumumab
J. Clin. Oncol., August 1, 2007; 25(22): 3238 - 3245.
[Abstract] [Full Text] [PDF]

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 Mol Cancer ResHome page
M. Toulany, M. Baumann, and H. P. Rodemann
Stimulated PI3K-AKT Signaling Mediated through Ligand or Radiation-Induced EGFR Depends Indirectly, but not Directly, on Constitutive K-Ras Activity
Mol. Cancer Res., August 1, 2007; 5(8): 863 - 872.
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E. Van Cutsem, C. Verslype, and P. A. Grusenmeyer
Lessons Learned in the Management of Advanced Pancreatic Cancer
J. Clin. Oncol., May 20, 2007; 25(15): 1949 - 1952.
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E. Van Cutsem, M. Peeters, S. Siena, Y. Humblet, A. Hendlisz, B. Neyns, J.-L. Canon, J.-L. Van Laethem, J. Maurel, G. Richardson, et al.
Open-Label Phase III Trial of Panitumumab Plus Best Supportive Care Compared With Best Supportive Care Alone in Patients With Chemotherapy-Refractory Metastatic Colorectal Cancer
J. Clin. Oncol., May 1, 2007; 25(13): 1658 - 1664.
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 Cancer Res.Home page
S. Benvenuti, A. Sartore-Bianchi, F. Di Nicolantonio, C. Zanon, M. Moroni, S. Veronese, S. Siena, and A. Bardelli
Oncogenic Activation of the RAS/RAF Signaling Pathway Impairs the Response of Metastatic Colorectal Cancers to Anti-Epidermal Growth Factor Receptor Antibody Therapies
Cancer Res., March 15, 2007; 67(6): 2643 - 2648.
[Abstract] [Full Text] [PDF]

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 Clin. Cancer Res.Home page
R. Rosell, M. Taron, N. Reguart, D. Isla, and T. Moran
Epidermal Growth Factor Receptor Activation: How Exon 19 and 21 Mutations Changed Our Understanding of the Pathway
Clin. Cancer Res., December 15, 2006; 12(24): 7222 - 7231.
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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.
[Abstract] [Full Text] [PDF]


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