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 increasing likelihood of effectiveness of an ErbB antagonist cancer treatment, which method comprises administering a cancer treating dose of the ErbB antagonist to a subject, wherein an erbB gene in tumor cells in a tissue sample from the subject has been found to be amplified. 
     
     
         7 . The method according to  claim 6 , wherein the ErbB is a HER2 protein. 
     
     
         8 . The method according to  claim 7 , wherein the cancer is breast cancer. 
     
     
         9 . The method according to  claim 8 , wherein the subject has been found to have a 0 or 1+ score by immunohistochemistry on a formaldehyde-fixed tissue sample. 
     
     
         10 . The method according to  claim 6 , wherein the ErbB antagonist is an anti-ErbB antibody. 
     
     
         11 . The method according to  claim 10 , wherein the ErbB is HER2, and the antibody is recombinant human monoclonal antibody (rhuMAb) 4D5. 
     
     
         12 . The method according to  claim 6  wherein the erbB gene amplification is detected by detecting fluorescence of a fluorescent-labeled nucleic acid probe hybridized to the gene. 
     
     
         13 . The method according to  claim 12 , wherein the erbB gene is a her2 gene. 
     
     
         14 . The method according to  claim 6 , which further comprises administering a cancer treating dose of a chemotherapeutic drug. 
     
     
         15 . The method according to  claim 14 , wherein the ErbB is HER2 and the chemotherapeutic drug is a taxoid. 
     
     
         16 . The method according to  claim 6  wherein the likelihood of effectiveness increases by about 30%. 
     
     
         17 . A method for increasing likelihood of effectiveness of an anti-HER2 antibody to treat cancer, which method comprises administering a cancer treating dose of the anti-HER2 antibody to the subject, wherein a her2 gene in tumor cells in a tissue sample from the subject have been found to be amplified. 
     
     
         18 . The method according to  claim 17 , wherein the subject has been found to have a 0 or 1+ score by immunohistochemistry on a formaldehyde-fixed tissue sample. 
     
     
         19 . The method according to  claim 17 , which further comprises administering a cancer treating dose of a taxoid. 
     
     
         20 . A pharmaceutical package comprising:
 (a) a container comprising an ErbB antagonist for treating a cancer; and   (b) instructions to administer the ErbB antagonist to a subject if an erbB gene in tumor cells in a tissue sample from the subject is amplified.   
     
     
         21 . The package of  claim 20 , wherein the ErbB antagonist is an antibody. 
     
     
         22 . The package of  claim 21 , wherein the antibody is an anti-HER2 antibody. 
     
     
         23 . The package of  claim 22 , wherein the anti-HER2 antibody is rhuMAb 4D5 (Herceptin®). 
     
     
         24 . The package of  claim 20 , wherein the instructions further comprise directions to administer a chemotherapeutic drug in combination with the ErbB antagonist. 
     
     
         25 . The package of  claim 24 , wherein the chemotherapeutic drug is a taxoid. 
     
     
         26 . A method for identifying a patient disposed to respond favorably to an ErbB antagonist for treating cancer, which method comprises detecting erbB gene amplification in tumor cells in a tissue sample from the patient. 
     
     
         27 . The method according to  claim 26 , wherein the subject has been found to have a 0 or 1+ score by immunohistochemistry on a formaldehyde-fixed tissue sample. 
     
     
         28 . The method according to  claim 26 , wherein the erbB is her2.