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Originally published in Science Express on 29 April 2004
Science 4 June 2004:
Vol. 304. no. 5676, pp. 1497 - 1500
DOI: 10.1126/science.1099314
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EGFR Mutations in Lung Cancer: Correlation with Clinical Response to Gefitinib Therapy

J. Guillermo Paez,1,2* Pasi A. Jänne,1,2* Jeffrey C. Lee,1,3* Sean Tracy,1 Heidi Greulich,1,2 Stacey Gabriel,4 Paula Herman,1 Frederic J. Kaye,5 Neal Lindeman,6 Titus J. Boggon,1,3 Katsuhiko Naoki,1 Hidefumi Sasaki,7 Yoshitaka Fujii,7 Michael J. Eck,1,3 William R. Sellers,1,2,4{dagger} Bruce E. Johnson,1,2{dagger} Matthew Meyerson1,3,4{dagger}

Receptor tyrosine kinase genes were sequenced in non–small cell lung cancer (NSCLC) and matched normal tissue. Somatic mutations of the epidermal growth factor receptor gene EGFR were found in 15of 58 unselected tumors from Japan and 1 of 61 from the United States. Treatment with the EGFR kinase inhibitor gefitinib (Iressa) causes tumor regression in some patients with NSCLC, more frequently in Japan. EGFR mutations were found in additional lung cancer samples from U.S. patients who responded to gefitinib therapy and in a lung adenocarcinoma cell line that was hypersensitive to growth inhibition by gefitinib, but not in gefitinib-insensitive tumors or cell lines. These results suggest that EGFR mutations may predict sensitivity to gefitinib.

1 Departments of Medical Oncology and Cancer Biology, Dana-Farber Cancer Institute, Boston, MA 02115, USA.
2 Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA.
3 Departments of Pathology and Biological Chemistry and Molecular Pharmacology, Harvard Medical School, Boston, MA 02115, USA.
4 The Broad Institute at MIT and Harvard, Cambridge, MA 02142, USA.
5 Genetics Branch, National Cancer Institute, National Naval Medical Center, Bethesda, MD 20889, USA.
6 Department of Pathology, Brigham and Women's Hospital, Boston MA 02115, USA.
7 Department of Surgery 2, Nagoya City University Medical School, Nagoya 467-8601, Japan.



Note added in proof: Similar results are being reported by T. J. Lynch et al. (28).

* These authors contributed equally to this work.

{dagger} To whom correspondence should be addressed. E-mail: William_Sellers{at}dfci.harvard.edu; Bruce_Johnson{at}dfci.harvard.edu; Matthew_Meyerson{at}dfci.harvard.edu

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Dual silencing of insulin-like growth factor-I receptor and epidermal growth factor receptor in colorectal cancer cells is associated with decreased proliferation and enhanced apoptosis.
S. Kaulfuss, P. Burfeind, J. Gaedcke, and J.-G. Scharf (2009)
Mol. Cancer Ther. 8, 821-833
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Identification of CD20 C-Terminal Deletion Mutations Associated with Loss of CD20 Expression in Non-Hodgkin's Lymphoma.
Y. Terui, Y. Mishima, N. Sugimura, K. Kojima, T. Sakurai, Y. Mishima, R. Kuniyoshi, A. Taniyama, M. Yokoyama, S. Sakajiri, et al. (2009)
Clin. Cancer Res. 15, 2523-2530
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First-Line Gefitinib for Patients With Advanced Non-Small-Cell Lung Cancer Harboring Epidermal Growth Factor Receptor Mutations Without Indication for Chemotherapy.
A. Inoue, K. Kobayashi, K. Usui, M. Maemondo, S. Okinaga, I. Mikami, M. Ando, K. Yamazaki, Y. Saijo, A. Gemma, et al. (2009)
J. Clin. Oncol. 27, 1394-1400
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Cetuximab Attenuates Metastasis and u-PAR Expression in Non-Small Cell Lung Cancer: u-PAR and E-Cadherin are Novel Biomarkers of Cetuximab Sensitivity.
D. A. Nikolova, I. A. Asangani, L. D. Nelson, D. P.M. Hughes, D. R. Siwak, G. B. Mills, A. Harms, E. Buchholz, L. R. Pilz, C. Manegold, et al. (2009)
Cancer Res. 69, 2461-2470
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Single-Molecule Detection of Epidermal Growth Factor Receptor Mutations in Plasma by Microfluidics Digital PCR in Non-Small Cell Lung Cancer Patients.
T. K.F. Yung, K.C. A. Chan, T. S.K. Mok, J. Tong, K.-F. To, and Y.M. D. Lo (2009)
Clin. Cancer Res. 15, 2076-2084
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Randomized Phase II Trial of Erlotinib Versus Temozolomide or Carmustine in Recurrent Glioblastoma: EORTC Brain Tumor Group Study 26034.
M. J. van den Bent, A. A. Brandes, R. Rampling, M. C.M. Kouwenhoven, J. M. Kros, A. F. Carpentier, P. M. Clement, M. Frenay, M. Campone, J.-F. Baurain, et al. (2009)
J. Clin. Oncol. 27, 1268-1274
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Overview of Gefitinib in Non-small Cell Lung Cancer: An Asian Perspective.
H. Jiang (2009)
Jpn. J. Clin. Oncol. 39, 137-150
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Molecular determinants of response to matuzumab in combination with paclitaxel for patients with advanced non-small cell lung cancer.
M. M. Schittenhelm, C. Kollmannsberger, K. Oechsle, A. Harlow, J. Morich, F. Honecker, R. Kurek, S. Storkel, L. Kanz, C. L. Corless, et al. (2009)
Mol. Cancer Ther. 8, 481-489
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The Expression of Three Genes in Primary Non-Small Cell Lung Cancer Is Associated with Metastatic Spread to the Brain.
H. Grinberg-Rashi, E. Ofek, M. Perelman, J. Skarda, P. Yaron, M. Hajduch, J. Jacob-Hirsch, N. Amariglio, M. Krupsky, D. A. Simansky, et al. (2009)
Clin. Cancer Res. 15, 1755-1761
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A Systems Perspective of Ras Signaling in Cancer.
E. C. Stites and K. S. Ravichandran (2009)
Clin. Cancer Res. 15, 1510-1513
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Somatic Mutations of ErbB4: SELECTIVE LOSS-OF-FUNCTION PHENOTYPE AFFECTING SIGNAL TRANSDUCTION PATHWAYS IN CANCER.
D. Tvorogov, M. Sundvall, K. Kurppa, M. Hollmen, S. Repo, M. S. Johnson, and K. Elenius (2009)
J. Biol. Chem. 284, 5582-5591
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Epidermal Growth Factor Receptor Signaling Synergizes with Hedgehog/GLI in Oncogenic Transformation via Activation of the MEK/ERK/JUN Pathway.
H. Schnidar, M. Eberl, S. Klingler, D. Mangelberger, M. Kasper, C. Hauser-Kronberger, G. Regl, R. Kroismayr, R. Moriggl, M. Sibilia, et al. (2009)
Cancer Res. 69, 1284-1292
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Whole Genome Comparison of Allelic Imbalance between Noninvasive and Invasive Small-Sized Lung Adenocarcinomas.
H. Nakanishi, S. Matsumoto, R. Iwakawa, T. Kohno, K. Suzuki, K. Tsuta, Y. Matsuno, M. Noguchi, E. Shimizu, and J. Yokota (2009)
Cancer Res. 69, 1615-1623
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Targeted Cancer Therapeutics.
W. N. Hait and T. W. Hambley (2009)
Cancer Res. 69, 1263-1267
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Mutations and Response to Epidermal Growth Factor Receptor Inhibitors.
P. Laurent-Puig, A. Lievre, and H. Blons (2009)
Clin. Cancer Res. 15, 1133-1139
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EGFR-TKI and lung adenocarcinoma with CNS relapse: interest of molecular follow-up.
A-M. Ruppert, M. Beau-Faller, A. Neuville, E. Guerin, A-C. Voegeli, B. Mennecier, M. Legrain, A. Molard, M-Y. Jeung, M-P. Gaub, et al. (2009)
Eur. Respir. J. 33, 436-440
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MET increased gene copy number and primary resistance to gefitinib therapy in non-small-cell lung cancer patients.
F. Cappuzzo, P. A. Janne, M. Skokan, G. Finocchiaro, E. Rossi, C. Ligorio, P. A. Zucali, L. Terracciano, L. Toschi, M. Roncalli, et al. (2009)
Ann. Onc. 20, 298-304
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Experimental results and related clinical implications of PET detection of epidermal growth factor receptor (EGFr) in cancer.
M. A. Pantaleo, M. Nannini, A. Maleddu, S. Fanti, C. Nanni, S. Boschi, F. Lodi, G. Nicoletti, L. Landuzzi, P. L. Lollini, et al. (2009)
Ann. Onc. 20, 213-226
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Positron Emission Tomography (PET) Imaging with [11C]-Labeled Erlotinib: A Micro-PET Study on Mice with Lung Tumor Xenografts.
A. A. Memon, S. Jakobsen, F. Dagnaes-Hansen, B. S. Sorensen, S. Keiding, and E. Nexo (2009)
Cancer Res. 69, 873-878
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Proteasome Inhibition Blocks Ligand-Induced Dynamic Processing and Internalization of Epidermal Growth Factor Receptor via Altered Receptor Ubiquitination and Phosphorylation.
A. H. Kesarwala, M. M. Samrakandi, and D. Piwnica-Worms (2009)
Cancer Res. 69, 976-983
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Addition of S-1 to the Epidermal Growth Factor Receptor Inhibitor Gefitinib Overcomes Gefitinib Resistance in Non-small cell Lung Cancer Cell Lines with MET Amplification.
T. Okabe, I. Okamoto, S. Tsukioka, J. Uchida, E. Hatashita, Y. Yamada, T. Yoshida, K. Nishio, M. Fukuoka, P. A. Janne, et al. (2009)
Clin. Cancer Res. 15, 907-913
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Expression of epidermal growth factor receptor in relation to BRCA1 status, basal-like markers and prognosis in breast cancer.
J B Arnes, L R Begin, I Stefansson, J-S Brunet, T O Nielsen, W D Foulkes, and L A Akslen (2009)
J. Clin. Pathol. 62, 139-146
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Effect of Lapatinib on the Development of Estrogen Receptor-Negative Mammary Tumors in Mice.
T. E. Strecker, Q. Shen, Y. Zhang, J. L. Hill, Y. Li, C. Wang, H.-T. Kim, T. M. Gilmer, K. R. Sexton, S. G. Hilsenbeck, et al. (2009)
J Natl Cancer Inst 101, 107-113
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