Ovarian Cancer is not something I spend a lot of time working on, but it’s a terrible disease, mostly because it’s usually diagnosed very late, making it very difficult to successfully treat. Sure, the BRCA gene story has segment some of those people, but then they’re having prophylactic surgery (removal of breast and/or ovaries) to avoid the future possibility of cancer. One would think that a better option is needed.
The study presented is really interesting in how effective it is at identifying early disease and thereby limiting surgical removal of actual diseased organs and effecting cures. A simple blood test done regularly over time can screen people and help target those with hints of problems, escalating interventions as required. This approach clearly works, and actually works very well.
Now the problem is the money. How much does it cost to save someone’s life? There is a metric known as QALY (Quality Adjusted Life Year) that’s used to calculate the “value” of an intervention. Sometimes the calculation gets very complex, but it usually only takes into account the health care costs, not the societal costs, so it’s not always a great way to measure “value”. A standard, conservative figure for QALY value is $50,000. That means that a treatment would cost $50,000 for every year of life saved. Some inexpensive blood pressure medications come in around $15-30,000; an annual screening mammogram for women over 50 works out around that $50k number. The challenge comes in when you stretch the target audience – for women over 40, the number rises to around $200k. In the case of screening for prostate cancer, there’s never been a figure calculated because it’s not clear screening actually saves lives, but that’s another story.
Here we have a very clear option for screening that is very good at finding the target. It now will have to wait for the economics to be determined and whether or not saving these lives “is worth it”.
From the Journal of Clinical Oncology / By Chae Young Han, PhD, Karen H. Lu, MD, Gwen Corrigan, 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
Abstract
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: NCT00539162). 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 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.