Use of HE4 and other biochemical markers for assessment of endometrial and uterine cancers

• US 20080020473A1
• Filed: 01/04/2007
• Published: 01/24/2008
• Est. Priority Date: 01/04/2006
• Status: Abandoned Application

• Current Assignee: Fujirebio America, Inc. (H.U. Group Holdings, Inc.)
• Original Assignee: Fujirebio America, Inc. (H.U. Group Holdings, Inc.)
• Inventors: Moore, Richard, Somers, Elizabeth, Allard, W.
• Application Number:
  US11/650,573
• Publication Number:
  US 20080020473A1
• Time in Patent Office: Days
• US Class Current: 436/64
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 16/3069 Reproductive system, e.g. ovaria, uterus, testes, prostate
• CPC Class Codes: G01N 33/57442 of the uterus and endometrial

Abstract

The disclosure relates to use of the HE4/HE4a marker(s) to assess endometrial and uterine cancer in a patient. The disclosure also relates to using tumors marks for diagnosis, grading and staging of endometrial and uterine cancers. The disclosure also relates to determining prognosis and treatment effectiveness of a patient who has been diagnosed with endometrial or uterine cancer.

Claims

1. A method of assessing whether a patient is afflicted with an endometrial or uterine 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 an endometrial or uterine 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, serum, peritoneal fluid, urine, and vaginal fluid.

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 selected from the group consisting of a peritoneal wash fluid and a vaginal douche fluid.

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 an endometrial or uterine 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 marker selected from the group consisting of CA125 and SMRP in the sample, wherein elevated expression of the second marker is a further indication that the patient is afflicted with an endometrial or uterine cancer.

11. The method of claim 1, further comprising assessing expression of both CA125 and SMRP in the sample, wherein elevated expression of either of CA125 and SMRP is a further indication that the patient is afflicted with an endometrial or uterine cancer.

12. A method of assessing the response of a patient afflicted with an endometrial or uterine 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.

13. The method of claim 12, further comprising assessing expression of a second marker selected from the group consisting of CA125 and SMRP in the sample, wherein decreased expression of the second marker is a further indication that the patient is responding to the treatment.

14. The method of claim 12, further comprising assessing expression of both CA125 and SMRP in the sample, wherein decreased expression of either of CA125 and SMRP is a further indication that the patient is responding to the treatment.

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

16. The method of claim 15, further comprising assessing expression of a second marker selected from the group consisting of CA125 and SMRP in the sample, wherein elevated expression of the second marker is a further indication that the endometrial or uterine cancer is recurring in the patient.

17. The method of claim 15, further comprising assessing expression of both CA125 and SMRP in the sample, wherein elevated expression of either of CA125 and SMRP is a further indication that the endometrial or uterine cancer is recurring in the patient.

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

19. A method of assessing the likelihood that a patient will develop an endometrial or uterine 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 an endometrial or uterine cancer.

20. The method of claim 19, further comprising assessing expression of a second marker selected from the group consisting of CA125 and SMRP in the sample, wherein elevated expression of the second marker is a further indication that the patient will develop an endometrial or uterine cancer.

21. The method of claim 19, further comprising assessing expression of both CA125 and SMRP in the sample, wherein elevated expression of either of CA125 and SMRP is a further indication that the patient will develop an endometrial or uterine cancer.

22. A method of staging a tumor in a patient afflicted with an endometrial or uterine 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.

23. The method of claim 22, further comprising assessing expression of a second marker selected from the group consisting of CA125 and SMRP in the sample, wherein elevated expression of the second marker further indicates a more advanced stage of the cancer.

24. The method of claim 22, further comprising assessing expression of both CA125 and SMRP in the sample, wherein elevated expression of either of CA125 and SMRP further indicates a more advanced stage of the cancer.

25. A method of grading a tumor in a patient afflicted with an endometrial or uterine 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 of the cancer.

26. The method of claim 25, further comprising assessing expression of a second marker selected from the group consisting of CA125 and SMRP in the sample, wherein elevated expression of the second marker further indicates a higher grade of the of the cancer.

27. The method of claim 25, further comprising assessing expression of both CA125 and SMRP in the sample, wherein elevated expression of either of CA125 and SMRP further indicates a higher grade of the of the cancer.

28. A method for assessing the need of a patient diagnosed with an endometrial or uterine 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.

29. The method of claim 28, further comprising assessing expression of a second marker selected from the group consisting of CA125 and SMRP in the sample, wherein elevated expression of the second marker further indicates need of the patient for the therapeutic intervention.

30. The method of claim 28, wherein the therapeutic intervention is a chemotherapy.