Non small cell lung cancer (NSCLC) is one of the most common cancers worldwide. Pulmonary malignancies are the leading cause of death in both men and women1. Treatment generally consists of surgical resection, radiation therapy and/or chemotherapy. Gefitinib, or Iressa, was recently approved for the FDA for the treatment of refractory NSCLC, in part, due to the impressive response seen in only about 10-15% of patients2.
Two recent journal publications have shed new light on what separates the “responders” from the “non-responders” to Gefitinib. Both journals reported that virtually all those who responded to Iressa (Gefitinib) were found to have a somatic mutation in a mutational “hotspot” within the kinase domain of the EGFR gene (Exons 18-21)3, 4. This is the precise location where Gefitinib interacts with the EGFR protein. These studies went on to demonstrate that cells with mutations in the protein kinase domain are more sensitive to stimulation by EGFR, and more sensitive to inhibition by Gefitinib. A similar association was subsequenctly reported by Pao et al. for responsiveness to Tarceva (Erlotinib)5, another small molecule drug directed at the kinase domain of the EGFR protein.
To open a printable assay summary in a new window, click the link below.
EGFR Gene Mutation Analysis Assay Summary
(in portable document format (pdf) which requires Adobe® Acrobat® Reader™ to view or print; download latest version free)
Please submit the Test Request Form (TRF) and the EGFR Patient Information Form when ordering this test.
EGFR Mutation Database
A database of EGFR mutations reported in the public scientific literature and compiled here for your convenience.
References
1. Ries LAG, Kosary CL, Hankey BF, et al, editors. “SEER Cancer Statistics Review, 1973 1996”. Bethesda, MD: National Cancer Institute; 1999.
2. Fukuoka M et al. J Clin Oncol. 2003 Jun 15;21(12):2237-46.
3. Lynch TJ et al. N Engl J Med. 2004 May 20;350(21):2129-39.
4. Paez JG et al. Science. 2004 Jun 4;304(5676):1497-500.
5. Pao W et al. Proc Natl Acad Sci U S A. 2004 Sep 7;101(36):13306-11.
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