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Algorithm showed high specificity, PPV as ovarian cancer screen
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2010 ASCO Annual Meeting
Researchers said that a Risk of Ovarian Cancer Algorithm based on a patient’s age and trends in CA-125 blood test results over time was highly specific for ovarian cancer in patients aged 50 years or older.
Karen Lu, MD, professor of gynecologic oncology at The University of Texas M.D. Anderson Cancer Center, said the results represent another step towards what she called the Holy Grail: a reliable screening test for early-stage ovarian cancer.
“The beauty of the ROCA algorithm is that each woman ultimately establishes her own baseline based on her prior CA-125 values,” Lu said.
In a single arm, prospective, multicenter screening study, researchers recruited 3,328 women aged 50 to 74 who had no significant family history of breast or ovarian cancer. Participants underwent an annual CA-125 blood test, and based on the results produced by the Risk of Ovarian Cancer Algorithm, researcher segregated women into low-, intermediate- and high-risk groups.
Women at low-risk were supposed to continue annual CA-125 testing, women at intermediate-risk were told to repeat the CA-125 in three months, and women at high-risk were ordered to undergo transvaginal sonography and referred to a gynecologic oncologist.
Based on clinical findings, and the results of the transvaginal sonography, the gynecologic oncologist then decided whether to proceed with surgery.
Lu said eight women underwent surgery. Surgeons discovered three invasive ovarian cancers, two borderline ovarian tumors and three benign ovarian tumors. Based on those findings, the positive predictive value to detect an invasive ovarian cancer for the screening strategy was 37.5% (95% CI 8.5%-75.5%).
The combined specificity for the strategy was 99.9% (95% CI 99.7%-99.98%).
“It’s important to stress the clinical ramifications of this study,” Lu said. “This is not practice changing at this time. We need to await the results of a definitive ovarian cancer screening trial that examines mortality as an endpoint and uses the same ROCA algorithm.”
The study Lu referred to, the United Kingdom Familial Ovarian Cancer Screening Study, involves more than 200,000 women; results are expected in 2015. Lu added that if the algorithm is validated, CA-125 testing could be recommended as part of a woman’s annual check-up with a physician. – by Jason Harris
For more information:
- Lu HK. #5003. Presented ahead of: the 2010 ASCO Annual Meeting; June 4-8, 2010; Chicago.
This ROCA algorithm represents yet another example of personalized medicine. This also represents a more refined application of known technology. The CA-125 is widely available, as is transvaginal ultrasound, which is intrusive and also somewhat difficult to interpret technologically. As Dr. Lu points out, this larger evaluation, which we should have in a few years, if it is positive, may point us toward a screening strategy that may become part of the routine health exam for postmenopausal women. This study also highlights the relative rarity of this cancer —- out of 3,200 women, they discovered three invasive cancers. So, as Dr. Lu says, it’s very important that this strategy is not widely implemented until the confirmatory study is completed.
– Douglas W. Blayney, MD
Medical
Director, Comprehensive Cancer Center, University of Michigan
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