METHOD FOR DETERMINING THE PROGNOSIS OF CANCER PATIENTS BY MEASURING LEVELS OF BAG EXPRESSION

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.