FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.
There is a great deal of interest in finding a test or combination of tests that can detect ovarian cancer at an early stage. The tests with the greatest amount of clinical test data supporting their use are transvaginal ultrasound (TVUS) and the serum marker CA125 blood test. In studies of women at average risk of ovarian cancer, using TVUS and CA125 for screening led to more testing and sometimes more surgeries, but did not lower the number of deaths caused by ovarian cancer. For that reason, major medical and professional organizations do not recommend routine use of TVUS or CA-125 to screen for ovarian cancer.
Some organizations state that these tests may be considered for screening women at high risk of ovarian cancer due to a hereditary cancer syndrome. Still, it’s not clear that using these tests are effective for screening. This is the rationale for the September 2016 FDA Safety Communication which recommends against the use of screening tests for ovarian cancer.
Given the limitations of ovarian cancer screening, including the risks of both false positive and false negative results, risk-reducing salpingo-oophorectomy or RRSO (a surgical procedure that removes a woman’s ovaries and fallopian tubes) is recommended for high-risk women upon conclusion of childbearing.
Women at high risk for ovarian cancer often have valid reasons for delaying surgery. RRSO before natural menopause can be associated with significant side effects. Many women are in their 20s and 30s (younger than the recommended age for RRSO) when they learn of their increased ovarian cancer risk. Women who know they are at high-risk but are not yet ready to have surgery are faced with a difficult situation: utilize the available imperfect screening tools such CA125 and TVUS—or do nothing. Understandably, many feel that imperfect screening is better than no screening at all.
For this reason, FORCE felt it was important to respond to the FDA. Read our official statement on the issue.