OCEDP STUDY AIMS:

The purpose of this screening study program was do test whether CA–125 blood tests and annual ovarian ultrasounds help detect ovarian cancer early in women at increased risk.

RISK ELIGIBILITY CRITERIA:

  • – 2 first or second degree family relatives with breast or ovarian cancer

  • – If breast cancer was used for the risk, one individual must have had developed pre– menopausal breast cancer

  • – If of Ashkenazi ethnicity just one first degree family member or two second degree family member with breast or ovarian cancer

  • – The participant or family member carries a BRCA 1 or 2 genetic mutation

Between 2009 and 2015, the Marsha Rivkin Center for Ovarian Cancer Research, in collaboration with the Swedish Medical Center and the Fred Hutchinson Cancer Research Center, offered enrollment in OCEDP. Over the 6 year study a total of 534 participants were enrolled. The screening protocol included an annual transvaginal sonogram (TVS) and biannual CA–125 using the PEB algorithm to determine expected CA125 levels for each individual.

There were a total number of 92 participants choosing oophorectomy during the study period. 18 of those surgeries were study–indicated. 74 were prophylactic, or for non–study reasons.

A total of 5 ovarian cancers were identified during the study with the following specifics:

  • 1– Stage IIIC – elevated CA–125, abnormal TVS

  • 1– Stage IA – elevated CA–125, abnormal TVS

  • 1– Serious tubal intraepithelial (STIC) lesion identified at time of prophylactic surgery, normal screening tests

  • 2– Low malignant potential (LMP) tumors – abnormal TVS, normal CA–125

Genetic counseling was encouraged and the cost was included as a study benefit. A total of 142 participants attended a genetic counseling session offered through the study participation and 103 participants underwent genetic mutation testing. Of the 534 participants, 80 women had a genetic mutation as follows:

BRCA 1 genetic mutation –42; BRCA 2 genetic mutation –34; Lynch syndrome –4

CONCLUSION:

  • 1. All five participants diagnosed with ovarian cancer during the study were BRCA 1 & 2 negative

  • 2. CA–125 was positive in stage 2C and 3C, high grade ovarian cancer patients

  • 3. Transvaginal sonogram was positive in all five ovarian cancer patients

  • 4. One patient had her fallopian tubes removed prior to participation in the study and developed clear cell carcinoma of the ovary during the study

  • 5. The two low grade tumors and the occult lesion identified at the time of surgery were Stage 1, had complete resection and did not require chemotherapy.

  • 6. The two high grade cancers required chemo and are in complete remission

  • 7. Genetic counseling was educational and incentivized more enrollees in the study

  • 8. Swedish Cancer Institute is continuing the screening study as a clinical program.

  • 9. More than 90% of participants completed the program at a cost of approximately $500 per patient per year.

Citation Format: Shirley Gough RN, Paula Manner, Casey Daniels, Pam Paley, MD, Saul Rivkin, MD. OVARIAN CANCER EARLY DETECTION PROGRAM (OCEDP) [abstract]. In: Proceedings of the 11th Biennial Ovarian Cancer Research Symposium; Sep 12-13, 2016; Seattle, WA. Philadelphia (PA): AACR; Clin Cancer Res 2017;23(11 Suppl):Abstract nr AP02.

©2017 American Association for Cancer Research.
2017
American Association for Cancer Research.