The clinical utility of an elevated-risk multivariate index assay score in ovarian cancer patients

Abstract

Objective: Early involvement of specialists is associated with improved survival in ovarian cancer patients. However, only 33–60% of patients are currently being referred. A more effective strategy to get patients with an elevated risk of ovarian cancer to gynecologic oncologists is needed. The objective of this study was to evaluate the clinical utility of a multivariate index assay, OVA1*, by assessing its ability to drive referral of ovarian cancer patients to gynecologic oncologists prior to their first surgical intervention.

Research design and methods: Information on patients who received a multivariate index assay was collected retrospectively from 22 obstetricians/gynecologists through a chart review. Physicians were recruited from a variety of practices and hospitals representing major geographic regions within the United States. Clinical utility of the multivariate index assay was assessed by examining the rate at which obstetricians/gynecologists involved a gynecologic oncologist for patients with elevated-risk results prior to first surgical intervention.

Results: A total of 136 patients with elevated-risk assay results were assessed, of whom 122 underwent surgery to remove an adnexal mass. Prior to surgery, 98 (80%) of the patients were referred to a gynecologic oncologist with an additional 11 (9%) having a gynecologic oncologist available if required by intra-operative findings. Primary ovarian cancer was found in 65 (53%) patients, and gynecologic oncologists performed 61 (94%) of the initial surgeries these patients. Similar results were found in premenopausal and postmenopausal patients.

Conclusions: A high proportion of patients with elevated-risk assay results were referred to a gynecologic oncologist prior to their initial surgery. Nearly all of the patients who had primary ovarian malignancies were appropriately referred to gynecologic oncologists, highlighting the clinical utility of the multivariate index assay. Nearly all patients identified with ovarian cancer received their initial surgery by a gynecologic oncologist – demonstrating a higher rate of gynecologic oncologist involvement in comparison to past studies. The study may be limited by unintentional bias in physician response and recall.

Keywords:

• Adnexal mass
• Ovarian cancer
• MIA
• Multivariate index assay

Notes

*OVA1 is a registered trade name of Vermillion Inc., Austin, TX, U.S.A.