Objective We sought to analyze the effectiveness of a multivariate index assay (MIA) in identifying early-stage ovarian malignancy compared to clinical assessment, CA 125-II, and modified American Congress of Obstetricians and Gynecologists (ACOG) guidelines among women undergoing surgery for an adnexal mass. Study Design Patients were recruited in 2 related prospective, multiinstitutional trials involving 44 sites. All women had preoperative imaging and biomarker analysis. Preoperative biomarker values, physician assessment of ovarian cancer risk, and modified ACOG guideline risk stratification were correlated with surgical pathology. Results A total of 1016 patients were evaluable for MIA, CA 125-II, and clinical assessment. Overall, 86 patients (8.5%) had primary-stage I/II primary ovarian malignancy, with 70.9% having stage I disease and 29.1% having stage II disease. For all early-stage ovarian malignancies, MIA combined with clinical assessment had significantly higher sensitivity (95.3%; 95% confidence interval [CI], 88.6-98.2) compared to clinical assessment alone (68.6%; 95% CI, 58.2-77.4), CA 125-II (62.8%; 95% CI, 52.2-72.3), and modified ACOG guidelines (76.7%; 95% CI, 66.8-84.4) (P <.0001). Among the 515 premenopausal patients, the sensitivity for early-stage ovarian cancer was 89.3% (95% CI, 72.8-96.3) for MIA combined with clinical assessment, 60.7% (95% CI, 42.4-76.4) for clinical assessment alone, 35.7% (95% CI, 20.7-54.2) for CA 125-II, and 78.6% (95% CI, 60.5-89.8) for modified ACOG guidelines. Early-stage ovarian cancer in postmenopausal patients was correctly detected in 98.3% (95% CI, 90.9-99.7) of cases by MIA combined with clinical assessment, compared to 72.4% (95% CI, 59.8-82.2) for clinical assessment alone, 75.9% (95% CI, 63.5-85.0) for CA 125-II, and 75.9% (95% CI, 63.5-85.0) for modified ACOG guidelines. Conclusion MIA combined with clinical assessment demonstrated higher sensitivity for early-stage ovarian malignancy compared to clinical assessment alone, CA 125-II, and modified ACOG guidelines with consistent performance across menopausal status.
|Journal||American Journal of Obstetrics and Gynecology|
|State||Published - Jan 2014|
Bibliographical noteFunding Information:
This study was funded by Vermillion Inc , Austin, TX.
F.R.U. is a member of Vermillion Inc's speaker's bureau and has received travel reimbursement and honoraria for OVA1 speaking engagements. Z.Z. is coinventor of patents associated with the OVA1 product and is entitled to royalty payments from the sale of OVA1 test through a license agreement between Vermillion Inc and Johns Hopkins University. His work on OVA1 has been funded through sponsored research agreements between Vermillion Inc and Johns Hopkins University. D.W.C. serves on the Advisory Board at Vermillion Inc. E.T.F. was an employee of Vermillion Inc when the work was conducted and owns stock in Vermillion Inc. D.G.M. is Chief Scientific Officer and Vice President for Research and Development, Vermillion Inc. He has overseen the clinical study from Oct. 11, 2011, to the present. R.E.B. was principal investigator for the OVA1 trial and has been a member of Vermillion Inc's speaker's bureau since November 2011. He has not received honoraria from Vermillion Inc. A.S. is Vice-President, Biometrics at Applied Clinical Intelligence and is a statistical consultant for Vermillion Inc. The remaining author reports no conflict of interest.
- early stage
- ovarian cancer
ASJC Scopus subject areas
- Obstetrics and Gynecology