USE OF HE4 FOR ASSESSMENT OF BREAST CANCERS

• US 20100311099A1
• Filed: 03/31/2008
• Published: 12/09/2010
• Est. Priority Date: 03/29/2007
• Status: Active Grant

• Current Assignee: Curtis Glover, Jeffrey W. Allard, Thorsten Verch
• Original Assignee: Curtis Glover, Jeffrey W. Allard, Thorsten Verch
• Inventors: Verch, Thorsten, Allard, Jeffrey W, Glover, Curtis
• Granted Patent: US 8,455,189 B2
• Time in Patent Office: Days
• US Class Current: 435/29
• CPC Class Codes: G01N 2800/50 Determining the risk of developing a disease
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 2800/54 Determining the risk of relapse
• CPC Class Codes: G01N 2800/56 Staging of a disease; Further complications associated with the disease
• CPC Class Codes: G01N 33/57415 of breast

Abstract

The disclosure relates to use of the HE4 marker to assess breast cancer in a patient. The disclosure also relates to using HE4 and other tumors markers for diagnosis, grading and staging of breast cancers. The disclosure also relates to determining prognosis and treatment effectiveness of a patient who has been diagnosed with breast cancer.

Claims

1. A method of assessing whether a patient is afflicted with a breast cancer, the method comprising assessing expression of HE4 in a sample obtained from the patient, wherein elevated expression of HE4 is an indication that the patient is afflicted with breast cancer.

2. The method of claim 1, wherein the sample is a solid tissue sample.

3. The method of claim 1, wherein the sample is a body fluid obtained from the patient.

4. The method of claim 3, wherein the body fluid is selected from the group consisting of blood and serum.

5. The method of claim 1, wherein the sample is a fluid that has been contacted with the patient.

6. The method of claim 5, wherein the fluid is serum.

7. The method of claim 1, wherein expression of HE4 in the sample is compared with a reference value.

8. The method of claim 1, wherein the reference value corresponds to HE4 expression in patients who are not afflicted with breast cancer.

9. The method of claim 1, wherein expression of HE4 in the sample is compared with expression of HE4 in an earlier sample obtained at an earlier time from the patient.

10. The method of claim 1, further comprising assessing expression of a second breast cancer marker in the sample, wherein elevated expression of the second breast cancer marker is a further indication that the patient is afflicted with breast cancer.

11. A method of assessing the response of a patient afflicted with a breast cancer to a treatment, the method comprising assessing expression of HE4 in samples obtained from the patient at different times during treatment, wherein decreased expression of HE4 at the later time indicates that the patient is responding to the treatment.

12. The method of claim 11, further comprising assessing expression of a second breast cancer marker in the sample, wherein decreased expression of the second breast cancer marker is a further indication that the patient is responding to the treatment.

13. A method of assessing recurrence in a patient who has been treated for a breast cancer, the method comprising assessing expression of HE4 in samples obtained from the patient following treatment, wherein elevated expression of HE4 indicates that the breast cancer is recurring in the patient.

14. The method of claim 13, further comprising assessing expression of a second breast cancer marker in the sample, wherein elevated expression of the second breast cancer marker is a further indication that the breast cancer is recurring in the patient.

15. The method of claim 13, wherein expression of HE4 is assessed multiple times following the treatment, and wherein increasing expression of HE4 indicates that the breast cancer is recurring in the patient.

16. A method of assessing the likelihood that a patient will develop a breast cancer, the method comprising assessing expression of HE4 in a sample obtained from the patient, wherein elevated expression of HE4 is correlated with increased likelihood that the patient will develop a breast cancer.

17. The method of claim 16, further comprising assessing expression of a second breast cancer marker in the sample, wherein elevated expression of the second breast cancer marker is a further indication that the patient will develop a breast cancer.

18. A method of staging a tumor in a patient afflicted with a breast cancer, the method comprising assessing expression of HE4 in a sample obtained from the patient, wherein increasing expression of HE4 indicates a more advanced stage of the cancer.

19. A method of grading a tumor in a patient afflicted with a breast cancer, the method comprising assessing expression of HE4 in a sample obtained from the patient, wherein increasing expression of HE4 indicates a higher grade of the cancer.

20. A method for assessing the need of a patient diagnosed with a breast cancer for a therapeutic intervention, the method comprising assessing expression of HE4 in a sample obtained from the patient, wherein elevated expression of HE4 indicates need of the patient for the therapeutic intervention.

21. The method of claim 20, wherein the therapeutic intervention is a chemotherapy.