| Although cancer biomarkers predictive of a lung cancer patient’s response to certain therapies have been recognized, routine patient screening has not been put into practice. For example, mutations in two proteins, KRAS and EGFR, predict resistance and sensitivity respectively to the drugs erlotinib and gefitinib. However, screening patient tumors for the status of these markers has been significantly hampered in the past due to highly limited availability of tissue specimens in non-surgical patients. Further, the formalin-fixation process used to preserve tumors can create the appearance of mutations, leading to false interpretations. Novel, highly-sensitive assays capable of analyzing tumor DNA shed into patient blood are in development and present a solution to the historical problems presented by archival tumor samples. In this proposal, we seek to validate these assays on banked plasma specimens from two large randomized Southwest Oncology Group (SWOG) clinical trials in order to demonstrate their ability to predict patient outcome/response to the drugs gefitinib and cetuximab. The samples were carefully collected and stored and will provide statistically significant evidence to support the routine use of plasma biomarkers for patient personalized medicine.
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