Normal Risk Ovarian Screening Study: 21-Year Update

鈥� An ASCO Reading Room selection

March 6, 2024

Chae Young Han, PhD, Karen H. Lu, MD, Gwen Corrigan, BSN, Alexandra Perez, CMA, Sharlene D. Kohring, HSD, Joseph Celestino, BS, Deepak Bedi, MD, Enrique Bedia, MD, Therese Bevers, MD, David Boruta, MD, Matthew Carlson, MD, Laura Holman, MD, Leroy Leeds, MD, Cara Mathews, MD, Georgia McCann, MD, Richard G. Moore, MD, Matthew Schlumbrecht, MD, Brian Slomovitz, MD, Dan Tobias, MD, Yvette Williams-Brown, MD, Michael W. Bevers, MD, Jinsong Liu, MD, Terrie G. Gornet, BS, Beverly C. Handy, MD, Zhen Lu, MD, Jacob S. Bedia, BS, Steven J. Skates, PhD, and Robert C. Bast Jr, MD

Journal of Clinical Oncology

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Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.

Purpose

The Normal Risk Ovarian Screening Study (NROSS) tested a two-stage screening strategy in postmenopausal women at conventional hereditary risk where significantly rising cancer antigen (CA)-125 prompted transvaginal sonography (TVS) and abnormal TVS prompted surgery to detect ovarian cancer.

Methods

A total of 7,856 healthy postmenopausal women were screened annually for a total of 50,596 woman-years in a single-arm study (ClinicalTrials.gov identifier: ). Serum CA125 was analyzed with the Risk of Ovarian Cancer Algorithm (ROCA) each year. If risk was unchanged and <1:2,000, women returned in a year. If risk increased above 1:500, TVS was undertaken immediately, and if risk was intermediate, CA125 was repeated in 3 months with a further increase in risk above 1:500 prompting referral for TVS. An average of 2% of participants were referred to TVS annually.

Results

Thirty-four patients were referred for operations detecting 15 ovarian cancers and two borderline tumors with 12 in early stage (I-II). In addition, seven endometrial cancers were detected with six in stage I. As four ovarian cancers and two borderline tumors were diagnosed with a normal ROCA, the sensitivity for detecting ovarian and borderline cancer was 74% (17 of 23), and 70% of ROCA-detected cases (12 of 17) were in stage I-II. NROSS screening reduced late-stage (III-IV) disease by 34% compared with UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) controls and by 30% compared with US SEER values. The positive predictive value (PPV) was 50% (17 of 34) for detecting ovarian cancer and 74% (25 of 34) for any cancer, far exceeding the minimum acceptable study end point of 10% PPV.

Conclusion

While the NROSS trial was not powered to detect reduced mortality, the high specificity, PPV, and marked stage shift support further development of this strategy.

Read an interview about the study here.

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Normal Risk Ovarian Screening Study: 21-Year Update

Primary Source

Journal of Clinical Oncology

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