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Screening strategy identified ovarian cancer early in postmenopausal women
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A new two-stage ovarian cancer screening strategy that incorporates a carbohydrate antigen 125 blood test and Risk of Ovarian Cancer Algorithm calculation achieved high specificity with few false-positive results in a cohort of postmenopausal women, according to results of an 11-year study.
“Given the relatively low prevalence of ovarian cancer in the general population, a screening strategy that minimizes unnecessary operations due to false-positive values is crucial,” Karen H. Lu, MD, of the department of gynecologic oncology and reproductive medicine at The University of Texas MD Anderson Cancer Center, and colleagues wrote.
Karen H. Lu
Because there are no established screening strategies for ovarian cancer, Lu and colleagues set out to assess the potential of the two-stage ovarian cancer screening strategy in 4,051 postmenopausal women.
All women underwent an annual CA125 blood test. Based on the results of the Risk of Ovarian Cancer Algorithm, they were divided into one of three groups. Low-risk patients were to receive their next CA125 test 1 year later. Intermediate-risk patients were to receive a repeat CA125 test in 3 months. High-risk patients were to undergo transvaginal ultrasound and be referred to a gynecologic oncologist.
During the study period, the average annual rate of intermediate-risk classifications was 5.8% and the average annual rate of high-risk classifications was 0.9%.
Ten women underwent surgery based on results of transvaginal ultrasound. Of them, four had invasive ovarian cancer, two had tumors that were of low malignant potential, one had endometrial cancer and three had benign tumors. The results equated to a positive predictive value of 40% (95% CI, 12.2-73.8) for identifying ovarian cancer and a specificity of 99.9% (95% CI, 99.7-100).
“The results from our study are not practice changing at this time; however, our findings suggest that using a longitudinal screening strategy may be beneficial in postmenopausal women with an average risk for developing ovarian cancer,” Lu said in a press release. “We are currently waiting for the results of a larger, randomized study currently being conducted in the United Kingdom that uses the same Risk of Ovarian Cancer Algorithm in a similar population of women. If the results of this study are also positive, then this will result in a change in practice.”
Disclosure: The researchers report grant support from NCI and the Tracy Jo Wilson Ovarian Cancer Foundation; research funding from Abbott Diagnostics and Fujirebio Diagnostics; consulting roles with Abcodia, Fujirebio Diagnostics and Phillips Healthcare; and a speaking role with Phillips Healthcare.
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Ritu Salani, MD
Lu and colleagues report their results on the use of CA-125 levels over time and age to estimate the risk of ovarian cancer. They evaluated more than 4,000 women over 10 years (average of 4.2 screens per woman), of whom less than 7% had an abnormal CA-125 level that required additional intervention. In total, 117 women were triaged as high risk. Ultimately, 10 women underwent surgery. Researchers reported four cases of invasive ovarian cancer, all in early stages.
This study highlights the importance of using a trend in CA-125 levels, and not just a single value, which was also implicated in the ability to detect ovarian cancer sooner (not necessarily at earlier stages) in a retrospective analysis of the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial.
As a single-arm study, despite the detection of all invasive cancers in an early stage, these data are difficult to interpret and are not strong enough to be practice changing at this time. The incorporation of an ovarian cancer screening test will have to demonstrate an improvement in survival, which has not been demonstrated to date.
The results of a large randomized trial — the United Kingdom Collaborative Trial of Ovarian Cancer Screening — are anticipated to provide a more comprehensive picture and should be available within the next several years. Furthermore, identifying other biomarkers — which are currently being evaluated, alone or in conjunction with CA-125 levels — may be more beneficial. Therefore, though promising, the search for the Holy Grail in ovarian cancer continues.
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