Differential Diagnosis Of Cancer And Other Conditions Based On Expression Of p63

Abstract

This invention relates to methods of distinguishing among various types of differentiated and undifferentiated epithelial carcinomas, and non-epithelial carcinomas, by detecting the presence of p63 nucleic acid or protein expression. The invention also provides methods for detecting p63 nucleic acids and proteins, as well as methods for diagnosing and treating certain tumors based on whether the tumors express p63.

What is claimed: 
     
         1 . A method for distinguishing a differentiated lung cancer from an undifferentiated lung cancer, which method comprises detecting p63 expression in cells from a lung cancer, wherein p63 expression indicates that the lung cancer is a differentiated lung cancer and the absence of p63 expression indicates that the lung cancer is an undifferentiated lung cancer. 
     
     
         2 . The method according to  claim 1  wherein detecting p63 expression comprises detecting expression of p63 protein. 
     
     
         3 . The method according to  claim 2  wherein detecting p63 protein expression comprises detecting the p63 protein with an immunoassay. 
     
     
         4 . The method according to  claim 3  wherein the immunoassay is an immunohistochemical assay. 
     
     
         5 . The method according to  claim 1  wherein the differentiated lung cancer is selected from the group consisting of a poorly differentiated squamous cell carcinoma, a moderately differentiated squamous cell carcinoma, a well differentiated squamous cell carcinoma, an adenosquamous carcinoma, and an adenocarcinoma. 
     
     
         6 . The method according to  claim 1  wherein the differentiated lung cancer is a poorly differentiated squamous cell carcinoma. 
     
     
         7 . The method according to  claim 1  wherein the undifferentiated lung cancer is a small cell undifferentiated carcinoma. 
     
     
         8 . A method of treatment of lung cancer in a patient, which method comprises administering a chemotherapeutic agent to a patient diagnosed with a small cell undifferentiated carcinoma lung cancer, wherein the small cell undifferentiated carcinoma is distinguished from a squamous cell carcinoma by detecting an absence of p63 expression in cells from the lung cancer. 
     
     
         9 . A method according to  claim 8  wherein detecting p63 expression comprises detecting expression of p63 protein. 
     
     
         10 . The method according to  claim 9  wherein detecting p63 protein expression comprises detecting the p63 protein with an immunoassay. 
     
     
         11 . The method according to  claim 10  wherein the immunoassay is an immunohistochemical assay. 
     
     
         12 . A method of treatment of lung cancer in a patient, which method comprises surgically resecting a squamous cell carcinoma from a lung of a patient diagnosed with squamous cell carcinoma lung cancer, wherein the squamous cell carcinoma is distinguished from a small cell carcinoma by detecting p63 expression in cells from the lung cancer. 
     
     
         13 . A method according to  claim 12  wherein detecting p63 expression comprises detecting expression of p63 protein. 
     
     
         14 . The method according to  claim 13  wherein detecting p63 protein expression comprises detecting the p63 protein with an immunoassay. 
     
     
         15 . The method according to  claim 12  wherein the immunoassay is an immunohistochemical assay. 
     
     
         16 . A method for distinguishing a carcinoma of epithelial cells with squamous cell potential from a non-epithelial cell carcinoma, which method comprises detecting p63 expression in cells from a carcinoma, wherein p63 expression indicates that the carcinoma is a carcinomal of epithelial cells with squamous cell potential and the absence of p63 expression indicates that the carcinoma is a non-epithelial carcinoma or a carcinoma without squamous differentiation potential. 
     
     
         17 . The method according to  claim 16 , wherein the carcinoma without squamous differentiation potential is a glandular carcinoma. 
     
     
         18 . The method according to  claim 17 , wherein the glandular carcinoma is a renal carcinoma. 
     
     
         19 . The method according to  claim 16 , wherein the epithelial cells with squamous cell potential are selected from the group consisting of squamous epithelia, transitional cells, and glandular epithelia. 
     
     
         20 . A method for distinguishing a thyroid papillary carcinoma from another thyroid neoplasm, nodule, or enlargement, which method comprises detecting p63 expression in cells from a thyroid neoplasm, nodule, or enlargement, wherein p63 expression indicates that the neoplasm, nodule, or enlargement is a papillary carcinoma and the absence of p63 expression indicates that the neoplasm, nodule, or enlargement is not a papillary carcinoma. 
     
     
         21 . The method according to  claim 20 , wherein the neoplasm that is not a papillary carcinoma is a follicular adenoma, a medullary carcinoma, an anaplastic carcinoma, or a Hurthle cell carcinoma. 
     
     
         22 . A method for distinguishing a Hashimoto's thyroiditis from another thyroid inflammatory condition, which method comprises detecting p63 expression in cells from a thyroid inflammatory condition, wherein p63 expression indicates that the pathology is Hashimoto's thyroiditis. 
     
     
         23 . The method according to  claim 22 , wherein the inflammatory condition is not Hashimoto's thyroiditis. 
     
     
         24 . The method according to  claim 23 , wherein the inflammatory condition is Grave's disease.