Miller RW. Obstet Gynecol.
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
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
“Beyond identifying more malignancies, it is not
known precisely how the multivariate index assay will affect the referral of
patients,” the researchers wrote.