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OVA1 test outperformed CA125 for early ovarian cancer detection
Miller RW. Obstet Gynecol. 2011;doi:10.1097/AOG.0b013e31821b1d80.
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Replacing CA125 with the OVA1 multivariate index assay may better predict whether an ovarian mass is cancerous in premenopausal women and those with early-stage disease, according to data from a study recently published in Obstetrics & Gynecology.
Current American College of Obstetrics and Gynecology (ACOG) guidelines specify CA125 as the biomarker of choice in conjunction with other factors, including menopausal status, physical examination, family history, and imaging to determine patient risk levels and treatment plans.
Although these guidelines are useful for predicting advanced stage ovarian cancer, data from previous studies have shown that they are less useful for detecting earlier stages of disease — the form affecting 20% of women with these types of cancers.
Furthermore, a 1994 NIH consensus statement recommends that women at high risk for ovarian cancer who undergo primary surgery for ovarian masses have the option of having a gynecologic oncology specialist perform their surgery. But recent reports indicate that less than one-third actually receive referrals to such specialists.
Rachel Ware Miller, MD, an assistant professor of gynecologic oncology at the University of Kentucky Markey Cancer Center in Lexington, and colleagues enrolled 590 women with ovarian masses from 27 US primary care and specialty sites in a prospective trial to determine the effect of replacing the standard CA125-II assay with the OVA1. OVA1 is a new multivariate diagnostic biomarker that received FDA approval in 2009.
A total 516 of the originally enrolled women had ovarian masses that were evaluable. The researchers found 161 malignancies, of which 45 occurred in women who were premenopausal and 116 in women who were postmenopausal.
The researchers determined that incorporating OVA1 in lieu of CA125 improved the sensitivity of the ACOG referral guidelines (77% to 94%) and the negative predictive value (87% to 93%) while decreasing specificity (68% to 35%) and negative predictive value (87% to 93%), with similar outcomes in premenopausal women and those with early-stage disease.
These improvements enabled the researchers to detect almost 80% of all missed malignancies and more than 90% of missed epithelial ovarian cancers.
“Beyond identifying more malignancies, it is not known precisely how the multivariate index assay will affect the referral of patients,” the researchers wrote.
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