METHODS FOR PREDICTING THE EFFICACY OF TREATMENT

• US 20110045480A1
• Filed: 08/19/2010
• Published: 02/24/2011
• Est. Priority Date: 08/19/2009
• Status: Active Grant

• Current Assignee: Bioarray Genetics, Inc.
• Original Assignee: Bioarray Genetics, Inc.
• Inventors: FOURNIER, Marcia V., MARTIN, Katherine J.
• Granted Patent: US 9,771,618 B2
• Time in Patent Office: Days
• US Class Current: 435/6
• CPC Class Codes: A01N 61/00 Biocides, pest repellants or attractants, or plant growth regulators containing substances of unknown or undetermined composition, e.g. substances characterised only by the mode of action
• CPC Class Codes: C12Q 1/6886 for cancer immunoassay for cancer G01N33/574
• CPC Class Codes: C12Q 2600/106 Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism
• CPC Class Codes: C12Q 2600/118 Prognosis of disease development
• CPC Class Codes: C12Q 2600/158 Expression markers

Abstract

Clinical tests for testing therapeutic sensitivity of cancerous breast tissue and methods and kits for performing the same are described herein. Embodiments of the present invention are directed to methods for predicting the efficacy of treatment of breast cancer. In addition, certain embodiments are directed to a kit for testing therapeutic sensitivity of breast cancer tissue.

Claims

1. A method for predicting the efficacy of treatment of breast cancer comprising:

analyzing an expression profile of marker genes from a cancerous breast tissue; and

predicting the efficacy of treatment if the expression profile from the cancerous breast tissue matches a predetermined expression profile that indicates a patient will respond to the treatment wherein the marker gene is selected from a group consisting of ASPM, NCAPG, CDKN3, AURKA, FOXM1, CEP55, TNFRSF6B, FGFBP1, CAPRIN2, TUBG1, ZWILCH, RRM2, ACTB, ACTN1, EPHA2, TRIP13, CKS2, VRK1, DUSP4, EIF4A1, SERPINE2, ODC1 and combinations thereof.

2. The method of claim 1 further comprising developing an expression profile from said marker genes.

3. The method of claim 1, wherein the treatment is selected from a chemotherapeutic agent, radiation and a combination thereof.

4. The method of claim 3, wherein the chemotherapeutic agent comprises alkylating agents, antimetabolites, anthracyclines, anti-tumor inhibitors, anti-mitotic agents, topoisomerase I inhibitors, topoisomerase II inhibitors, corticosteroids and combinations thereof.

5. The method of claim 1 further comprising providing chemotherapy to said patients.

6. The method of claim 1, further comprising generating a report indicating the likelihood of long-term survival without breast cancer recurrence in a patient.

16. The method of claim 4 wherein the anti-mitotic agent is a taxane.

7. A kit for testing therapeutic sensitivity of breast cancer tissue comprising:

a means for identifying the expression profile of a tissue sample having probes to a specific set of genes or proteins associated with the disease; and

labels, reagents, and other materials or instructions for labeling and preparing reagents and other materials necessary to develop an expression profile of one or more marker genes.

8. The kit of claim 7, wherein the marker gene is selected from a group consisting of ASPM, NCAPG, CDKN3, AURKA, FOXM1, CEP55, TNFRSF6B, FGFBP1, CAPRIN2, TUBG1, ZWILCH, RRM2, ACTB, ACTN1, EPHA2, TRIP13, CKS2, VRK1, DUSP4, EIF4A1, SERPINE2, ODC1 and combinations thereof.

9. A clinical test for breast cancer comprising a means of detecting an expression pattern of one or more marker genes from diseased tissue of a patient;

wherein the expression level of at least one gene is modulated compared to other diseased tissue; and

wherein the modulation of at least one gene is indicative of a diseased tissue that is sensitive to a specific therapeutic agent.

10. The test of claim 9, wherein the marker gene is selected from the group consisting of ASPM, NCAPG, CDKN3, AURKA, FOXM1, CEP55, TNFRSF6B, FGFBP1, CAPRIN2, TUBG1, ZWILCH, RRM2, ACTB, ACTN1, EPHA2, TRIP13, CKS2, VRK1, DUSP4, EIF4A1, SERPINE2, ODC1 and combinations thereof.

11. A method of identifying a breast cancer patient who is likely to respond to a treatment for breast cancer comprising:

developing a genetic profile from marker genes from a breast tissue sample; and

identifying a breast cancer patient as likely to respond to a treatment for breast cancer if the expression profile matches a predetermined expression profile that indicates that a patient will respond to the treatment wherein the marker gene is selected from the group consisting of ASPM, NCAPG, CDKN3, AURKA, FOXM1, CEP55, TNFRSF6B, FGFBP1, CAPRIN2, TUBG1, ZWILCH, RRM2, ACTB, ACTN1, EPHA2, TRIP13, CKS2, VRK1, DUSP4, EIF4A1, SERPINE2, ODC1 and combinations thereof.

12. The method of claim 11, wherein the treatment is selected from a chemotherapeutic agent, radiation and a combination thereof.

13. The method of claim 12, wherein the chemotherapeutic agent comprises alkylating agents, antimetabolites, anthracyclines, anti-tumor inhibitors, anti-mitotic agents, topoisomerase I inhibitors, topoisomerase II inhibitors, corticosteroids and combinations thereof.

14. The method of claim 11 further comprising providing chemotherapy to said patients.

15. The method of claim 13 wherein the anti-mitotic agent is a taxane.