Method for predicting the response to her2-directed therapy

Abstract

This invention provides methods for determining or predicting response to HER2-directed therapy in an individual.

We claim: 
     
         1 . A method of treating a subject suffering from a tumor that overexpresses HER2, said method comprising:
 (a) immunohistochemically staining one or more samples of the tumor with an antibody that binds to NDF polypeptide;   (b) scoring the tumor for NDF polypeptide expression; and   (c) treating the subject by
 administering a course of therapy including trastuzumab therapy to subjects having an NDF-positive tumor. 
   
     
     
         2 . The method of  claim 1 , wherein the treating of the subject includes administration of at least one chemotherapeutic agent. 
     
     
         3 . The method of  claim 1 , further comprising:
 (d) immunohistochemically staining one or more samples of the tumor with an antibody that binds to an IGFR polypeptide and/or an antibody that binds to phosphorylated S6 polypeptide;   (e) scoring the tumor for IGFR expression and/or S6 polypeptide phosphorylation; and   (f) treating the subject by selecting subjects to monitor for relapse on the basis of NDF polypeptide expression, IGFR polypeptide expression and S6 polypeptide phosphorylation.   
     
     
         4 . The method of  claim 1 , wherein immunohistochemically staining one or more samples of the tumor is performed with an automated IHC/ISH slide stainer programmed to stain one or more tissue sections from the same tumor sample with:
 an antibody immunoreactive with HER2 or a nucleic acid probe set useful for detection of HER2 over-expression; and   an antibody immunoreactive with NDF.   
     
     
         5 . The method of  claim 4 , wherein immunohistochemically staining one or more samples of the tumor is performed with an automated IHC/ISH slide stainer further programmed to stain one or more tissue sections from the same tumor sample with:
 an antibody immunoreactive with IGFR; and/or   an antibody immunoreactive with phosphorylated S6 polypeptide.