Practice Advisory: FDA Issues Safety Communication on Screening Tests for Ovarian Cancer
On September 7, 2016, the U.S. Food and Drug Administration (FDA) released a Safety Communication about ovarian cancer screening tests (1). As detailed in the Safety Communication, currently available ovarian cancer screening tests, such as the Risk of Ovarian Cancer Algorithm (ROCA) test, are neither accurate nor reliable to screen asymptomatic women for early ovarian cancer. The FDA recommends against using currently offered tests to screen for ovarian cancer.
The FDA makes the following recommendations for physicians:
- Do not recommend or use tests that claim to screen for ovarian cancer in the general population of women. Be aware that testing higher risk asymptomatic patients for ovarian cancer has no proven benefit and is not a substitute for preventive actions that may reduce their risk.
- Consider referring women at high risk of developing ovarian cancer, including those with BRCA mutations, to a genetic counselor or gynecologic oncologist, or other appropriate health care provider for more specialized care.
Ovarian cancer is the fifth most common cause of cancer death among women (2). In 2013, 20,927 women in the United States were diagnosed with ovarian cancer, and 14,276 women in the United States died from ovarian cancer (3). The principal reason for these poor outcomes is the advanced stage of epithelial ovarian cancer at diagnosis. As stated in the College’s guidance, "The Role of the Obstetrician-Gynecologist in the Early Detection of Epithelial Ovarian Cancer," currently, there is no effective strategy for ovarian cancer screening (4).
The landmark UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) investigated the efficacy of screening strategies, including the use of ROCA for the interpretation of longitudinal CA125 (5). (A serum marker often found at high levels in women who have ovarian cancer, CA125 may also be elevated for other reasons.) While the UKTOCS data demonstrated promise, the researchers concluded that longer follow-up is needed to determine if the screening tests actually save lives and whether the benefits outweigh the harms of screening (such as unnecessary surgeries). As stated in a consensus paper developed by a group of scientists, clinicians, and advocates, “it is premature to recommend [multimodal screening with ROCA] for the early detection of ovarian cancer at this time” (6).
An effective screening test for ovarian cancer is needed. Unfortunately, based on current data, no such test currently exists. More research is still needed. Obstetrician-gynecologists should be aware that tests currently marketed to screen women (either at average or high risk) for ovarian cancer are not based on data. There are currently no available tests to effectively screen for ovarian cancer.
- Food and Drug Administration. The FDA recommends against using screening tests for ovarian cancer screening: FDA safety communication. Silver Spring (MD): FDA; 2016. Available at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm519413.htm. Retrieved September 7, 2016.
- Jayson GC, Kohn EC, Kitchener HC, Ledermann JA. Ovarian cancer. Lancet 2014;384:1376-88. PMID: 24767708.
- Centers for Disease Control and Prevention. Ovarian cancer statistics. Atlanta (GA): CDC; 2016. Available at: https://www.cdc.gov/cancer/ovarian/statistics. Retrieved September 7, 2016.
- The role of the obstetrician-gynecologist in the early detection of epithelial ovarian cancer. Committee Opinion No. 477. American College of Obstetricians and Gynecologists. Obstet Gynecol 2011;117:742-6.Retrieved September 7, 2016. PMID: 21343791.
- Jacobs IJ, Menon U, Ryan A, Gentry-Maharaj A, Burnell M, Kalsi JK, et al. Ovarian cancer screening and mortality in the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS): a randomised controlled trial [published erratum appears in Lancet 2016;387:944]. Lancet 2016;387:945-56. PMID: 26707054.
- What women and their physicians need to know about the UKCTOCS Study and ovarian cancer screening [editorial]. Am Fam Physician 2016;93:903-4.Retrieved September 7, 2016. PMID: 27331230.