Method for determining the prognosis of cancer patients by measuring levels of bag expression

Abstract

In accordance with the present invention, there are provided methods for determining a prognosis of disease free or overall survival in a patient suffering from cancer. Also provided are methods for predicting the risk of tumor recurrence or spread in an individual having a cancer tumor. Methods for screening a cancer patient to determine the risk of tumor metastasis; methods for determining the proper course of treatment for a patient suffering from cancer; and kits for use in practicing the invention methods.

1 - 50 . (canceled) 
     
     
         51 . A method for prognosis of disease-free or overall survival of an individual having node-positive breast cancer, wherein said individual has not received adjuvant chemotherapy, comprising determining the level of BAG-1 expression in infiltrating cells of a sample of tumor or infiltrating tumor cells from a body fluid of said patient, wherein a high level of BAG-1 expression relative to a reference level of BAG-1 expression correlates positively with disease-free or overall survival. 
     
     
         52 . The method of  claim 51 , wherein said level of BAG-1 expression is determined by measuring the amount of BAG-1 protein product using an immunoassay. 
     
     
         53 . The method of  claim 52 , wherein said immunoassay is an immuno-polymerase chain reaction (immuno-PCR) assay. 
     
     
         54 . The method of  claim 51 , wherein said level of BAG-1 expression is determined by measuring the level of BAG-1 protein that is detectable in samples selected from breast tumor tissue and breast tumor cells from a body fluid. 
     
     
         55 . The method of  claim 51 , further comprising determining if said level of BAG-1 expression represents an overproduction that is above a reference level of BAG-1 expression. 
     
     
         56 . The method of  claim 55 , wherein said reference level of BAG-1 expression is determined by a histogram analysis. 
     
     
         57 . The method of  claim 55 , wherein said reference level of BAG-1 expression is determined relative to a level of BAG-1 expression produced by in vitro cultured cells which produce BAG-1. 
     
     
         58 . The method of  claim 55 , wherein said reference level of BAG-1 expression is determined relative to a level of BAG-1 expression in non-cancerous cells. 
     
     
         59 . The method of  claim 51 , wherein said level of BAG-1 protein expression is determined by measuring the level of BAG-1 protein in a sample of breast tumor tissue. 
     
     
         60 . The method of  claim 51 , wherein said disease-free survival is distant metastasis-free survival. 
     
     
         61 . The method of  claim 51 , wherein said level of BAG-1 protein expression is determined by immunohistochemistry. 
     
     
         62 . The method of  claim 51 , wherein said level of BAG-1 protein expression is determined by measuring the level of BAG-1 protein in a sample of body fluid containing breast cancer cells. 
     
     
         63 . A method for predicting the risk of tumor recurrence or spread in an individual having a node-positive breast cancer tumor, wherein said individual has not received adjuvant chemotherapy, comprising determining the level of BAG-1 expression in infiltrating cells of a sample of said tumor or infiltrating breast tumor cells from a body fluid from said individual, wherein a high level of BAG-1 expression relative to a reference level of BAG-1 expression correlates negatively with tumor recurrence or spread. 
     
     
         64 . The method of  claim 63 , wherein said level of BAG-1 expression is determined by measuring the level of BAG-1 protein in a sample of breast tumor tissue. 
     
     
         65 . The method of  claim 63 , wherein said level of expression of BAG-1 is determined by immunohistochemistry. 
     
     
         66 . The method of  claim 63 , wherein said level of BAG-1 expression is determined by measuring the level of BAG-1 protein in a sample of body fluid containing breast cancer cells. 
     
     
         67 . The method of  claim 63 , further comprising:
 (a) determining an overproduction level for BAG-1 protein, said level being in excess of a minimum amount statistically determined to be indicative of decreased likelihood of tumor recurrence or spread;   (b) determining the level of BAG-1 protein expression in said tumor sample; and   (c) predicting said risk of tumor recurrence or spread wherein an overproduction level of BAG-1 protein in the tumor sample is negatively associated with the likelihood of tumor recurrence or spread.   
     
     
         68 . A method for screening a patient with node-positive breast cancer, wherein said patient has not received adjuvant chemotherapy, to determine the risk of tumor metastasis or chance of survival, said method comprising:
 (a) determining the level of expression of BAG-1 expression in infiltrating cells of a cancerous tissue sample or infiltrating tumor cells from a body fluid sample from said patient; and   (b) classifying a patient having high levels of expression of BAG-1 protein, relative to a reference level, as being less likely to suffer tumor metastasis or having an increased chance of survival.   
     
     
         69 . The method of  claim 68 , wherein said level of BAG-1 expression is determined by measuring the level of BAG-1 protein in a sample of breast tumor tissue. 
     
     
         70 . The method of  claim 68 , wherein said level of expression of BAG-1 is determined by immunohistochemistry. 
     
     
         71 . The method of  claim 68 , wherein said level of BAG-1 expression is determined by measuring the level of BAG-1 protein in a sample of body fluid containing breast cancer cells. 
     
     
         72 . The method of  claim 68 , wherein the level of expression of BAG-1 protein is measured using an immunoassay. 
     
     
         73 . The method of  claim 72 , wherein said immunoassay is an immuno-polymerase chain reaction assay. 
     
     
         74 . A method for determining the proper course of treatment for a patient suffering from node-positive breast cancer, wherein said patient has not received adjuvant chemotherapy, said method comprising:
 (a) determining the level of BAG-1 expression in infiltrating cells of a cancerous tissue sample or infiltrating tumor cells from a body fluid from said patient;   (b) identifying a first group of patients having low levels of BAG-1 expression relative to a reference level of BAG-1 expression, which first group of patients may require treatment proper for patients having a lesser chance of survival or being more likely to suffer tumor recurrence or spread; and   (c) identifying a second group of patients having high levels of BAG-1 expression relative to a reference level of BAG-1 expression, which second group of patients may require treatment proper for patients having a greater chance of survival and being less likely to suffer tumor recurrence or spread.   
     
     
         75 . The method of  claim 74 , wherein said level of BAG-1 expression is determined by measuring the level of BAG-1 protein in a sample of breast tumor tissue. 
     
     
         76 . The method of  claim 74 , wherein said level of BAG-1 expression is determined by immunohistochemistry. 
     
     
         77 . The method of  claim 74 , wherein said level of BAG-1 expression is determined by measuring the level of BAG-1 protein in a sample of body fluid containing breast cancer cells. 
     
     
         78 . A method for determining risk of tumor recurrence or spread in a patient suffering from a node-positive breast cancer, wherein said patient has not received adjuvant chemotherapy, said method comprising:
 (a) determining the level of expression of BAG-1 expression in infiltrating cells of a cancerous tissue of the patient; and   (b) classifying said patient as belonging either to a first group of patients having high levels of expression of BAG-1 relative to a reference level of BAG-1 expression, or a second group of patients having low levels of expression of BAG-1 relative to a reference level of BAG-1 expression,   wherein said first group has a lower likelihood of tumor recurrence or spread than said second group, thereby determining a lower risk of tumor recurrence or spread in the first group of patients suffering from breast cancer.   
     
     
         79 . The method of  claim 78 , wherein said level of BAG-1 expression is determined by measuring the level of BAG-1 protein in a sample of breast tumor tissue. 
     
     
         80 . The method of  claim 78 , wherein said level of expression of BAG-1 is determined by immunohistochemistry. 
     
     
         81 . The method of  claim 78 , wherein said level of BAG-1 expression is determined by measuring the level of BAG-1 protein in a sample of body fluid containing breast cancer cells.