Gene detection assay for improving the likelihood of an effective response to an egfr antagonist cancer therapy

Abstract

The invention provides a method for more effective treatment of patients susceptible to or diagnosed with tumors overexpressing EGFR, as determined by a gene amplification assay, with an EGFR antagonist. Such method comprises administering a cancer-treating dose of the EGFR antagonist, preferably in addition to chemotherapeutic agents, to a subject in whose tumor cells erbB1 gene has been found to be amplified e.g., by fluorescent in situ hybridization. EGFR antagonists described include an anti-EGFR antibody.

What is claimed: 
     
         1 . A method for identifying a patient disposed to respond favorably to an Epidermal Growth Factor Receptor (EGFR) antagonist for treating cancer, which method comprises detecting erbB1 gene amplification in tumor cells in a tissue sample from the patient. 
     
     
         2 . The method according to  claim 1 , wherein the subject has been found to have a 0 or 1+ score by immunohistochemistry on a formaldehyde-fixed tissue sample. 
     
     
         3 . The method according to  claim 1 , wherein the cancer is breast, bladder, lung, head, neck, or stomach cancer, or glioblastoma. 
     
     
         4 . The method according to  claim 1 , wherein erbB1 gene amplification is detected by detecting fluorescence of a fluorescent-labeled nucleic acid probe hybridized to the gene. 
     
     
         5 . The method according to  claim 1 , wherein the EGFR antagonist is an anti-EGFR antibody.