Method of determining a chemotherapeutic regimen by assaying gene expression in primary tumors

Abstract

The invention relates to a method for determining a chemotherapeutic regimen for an individual, comprising obtaining a mRNA sample from a primary tumor specimen; determining a gene expression level for a tumor gene determinant in the specimen; comparing the gene expression level for the tumor gene determinant with a predetermined threshold value for that gene; and providing a chemotherapeutic regimen comprising a chemotherapeutic agent appropriate for the tumor gene determinant to treat the tumor metastases.

1 . A method for determining a chemotherapeutic regimen for an individual having a primary and metastatic tumor, comprising 
 a) obtaining a mRNA sample from the individual's primary tumor specimen;    b) determining a gene expression level for a tumor gene determinant in the primary tumor specimen;    c) comparing the gene expression level for the tumor gene determinant with a predetermined threshold value for that tumor gene; and    d) providing a chemotherapeutic regimen comprising a chemotherapeutic agent appropriate for the tumor gene determinant to treat the individual having a tumor metastases.    
     
     
         2 . The method of  claim 1  wherein the tumor gene determinant is EGFR.  
     
     
         3 . The method of  claim 1  wherein the tumor gene determinant is DPD.  
     
     
         4 . The method of  claim 1  wherein the tumor gene determinant is TS.  
     
     
         5 . The method of  claim 1  wherein determining gene expression level comprises a fluorescence based real-time detection method.  
     
     
         6 . The method of  claim 5  wherein the tumor gene determinant is EGFR.  
     
     
         7 . The method of  claim 1  wherein the tumor gene determinant is DPD.  
     
     
         8 . The method of  claim 5  wherein the tumor gene determinant is TS.  
     
     
         9 . A method of determining whether a chemotherapeutic regimen comprising a chemotherapeutic agent appropriate for a tumor gene determinant in a primary tumor is appropriate for a tumor metastasis comprising, 
 a) obtaining an mRNA sample from the primary tumor,    b) determining an expression level of the tumor gene determinant,    c) comparing the expression level of the tumor gene determinant with a predetermined threshold level; and    d) determining the chemotherapeutic regimen for the tumor metastasis.    
     
     
         10 . The method of  claim 9  wherein the tumor gene determinant is EGER.  
     
     
         11 . The method of  claim 9  wherein the tumor gene determinant is DPD.  
     
     
         12 . The method of  claim 9  wherein the tumor gene determinant is TS.  
     
     
         13 . A method of determining whether an anti-metabolite, genotoxic, and/or receptor tyrosine kinase targeted gene expression based chemotherapeutic appropriate for treating a primary tumor is appropriate for treating a tumor metastasis comprising quantifying an amount of tumor gene determinant mRNA expression in fresh, frozen, fixed or fixed and paraffin-embedded (FPE) tissue relative to gene expression of an internal control in a primary tumor.  
     
     
         14 . The method of  claim 13  wherein the tumor gene determinant is DPD.  
     
     
         15 . The method of  claim 13  wherein the tumor gene determinant is TS.  
     
     
         16 . The method of  claim 13  wherein the tumor gene determinant is EGFR.