Monday, June 6, 2016

Have your female patients asked you about ROCA?

- Jennifer Middleton, MD, MPH

Smiling pictures of women greet visitors to the ROCA website along with infographics about ovarian cancer and a brief video describing the utility of ROCA in detecting ovarian cancer. The website describes that ROCA is intended as a "routine test" for post-menopausal women and extols that it is "the only test proven to detect ovarian cancer at an early stage." A "purchase the test" button figures prominently at the top corner of the home page, and it's not hard to imagine that many of our female patients might be tempted to do so. Unfortunately, rigorous study cannot yet validate these claims, and pitching this test directly to consumers sets a worrisome precedent.

The current issue of AFP covers the topic of ovarian cancer in detail, including an article on the Diagnosis and Management of Ovarian Cancer along with two editorials on ovarian cancer screening, one by representatives of the Ovarian Cancer Research Fund Alliance and one by AFP editor Dr. Jay Siwek. The first editorial describes the study that investigated the ROCA screening algorithm, and while there were many strengths to the study, Dr. Siwek in the second editorial rightly points out several concerns.

The Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) trial enrolled over 200,000 women in the United Kingdom and followed them for a median of 11 years. Participating women were randomized to one of three groups: annual multimodal screening (MMS) using ROCA, annual transvaginal ultrasound screening, or no screening. Although the authors found that the MMS group had a morality reduction compared to the other two groups after at least 7 years of annual screening, overall mortality among the three groups across the entire time period of the trial did not differ significantly. The authors themselves concluded that:

Further follow-up is needed to assess the extent of the mortality reduction before firm conclusions can be reached on the long-term efficacy and cost-effectiveness of ovarian cancer screening.

This conclusion is responsibly consistent with the published trial data, yet ROCA is still being sold to women with the promises described above. Offering a screening test directly to consumers prior to establishing its clinical utility is presumptuous at best and exploitative at worst; hopefully our patients will discuss ROCA with us prior to spending $295 on it. It will be up to us to discuss the shortcomings of this test, and ovarian cancer screening in general, with our patients.

Ovarian cancer remains the deadliest gynecologic cancer, largely because screening tests have been ineffective to date. The UKCTOCS trial is unlikely to change the current United States Preventive Services Task Force (USPSTF) D recommendation for ovarian cancer; to date, no screen has convincingly demonstrated decreased mortality, and screening can cause serious harm due to unnecessary surgical interventions for patients with false positive results. While the promise of ROCA holds understandable appeal, Dr. Siwek wisely advises us to "avoid the pitfalls of overscreening and wait for results that promise more hope than hype."

There's an AFP By Topic on Health Maintenance and Counseling if you'd like to read more on preventive care measures that are effective, and AFP's Choosing Wisely tool provides a useful review of the evidence base against ineffective screenings (such as those for ovarian cancer). As family physicians, we should continue to focus our preventive care on interventions that are proven to decrease mortality.