GENE DETECTION ASSAY FOR IMPROVING THE LIKELIHOOD OF AN EFFECTIVE RESPONSE TO AN ErbB 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.

1 - 5 . (canceled) 
     
     
         6 . A method for identifying a patient disposed to respond favorably to an ErbB antagonist for treating cancer, wherein the ErbB antagonist is an anti-HER2 protein antibody, wherein in a first analysis the patient's tumor cells have been determined to have a HER2 expression level of 0 or 1+ by immunohistochemistry on a formaldehyde-fixed tissue sample, followed by a second analysis which comprises detecting her2 gene amplification in tumor cells in a tissue sample from the patient. 
     
     
         7 . The method according to  claim 6 , wherein the cancer is breast cancer or gastric cancer. 
     
     
         8 . The method according to  claim 6 , wherein the anti-HER2 protein antibody is recombinant humanized monoclonal antibody rhuMAb 4D5-8. 
     
     
         9 . The method according to  claim 6 , wherein the her2 gene amplification is detected by detecting fluorescence of a fluorescent-labeled nucleic acid probe hybridized to the gene. 
     
     
         10 . The method according to  claim 6 , further comprising the step of administering to the patient the anti-HER2 protein antibody. 
     
     
         11 . The method of  claim 10 , wherein the anti-HER2 protein antibody is the recombinant humanized monoclonal antibody rhuMAb 4D5-8. 
     
     
         12 . The method of  claim 10  or  11  further comprising the step of administering to the patient a chemotherapeutic drug. 
     
     
         13 . The method according to  claim 12 , wherein the chemotherapeutic drug is a taxoid or vinorelbine. 
     
     
         14 . The method of  claim 13 , wherein the taxoid is paclitaxel.