FDA recommends against use of ovarian cancer screening

Based on recent, high-quality research evidence the U.S Food and Drug Administration (FDA) released a statement that advised against ovarian cancer screening. Health professionals should not recommend ovarian cancer screening tests to women who don’t have any symptoms because of the high possibility of unreliable results.

The FDA announced there are currently no screening tests for ovarian cancer that are sensitive enough to reliably screen for ovarian cancer. On the contrary, there are a high number of inaccurate results that could lead to mismanagement of patients.

In my recent blog I discussed the “8 reasons why ovarian cancer screening fails”. First and foremost, reliable tests are not available. CA125 and ultrasound findings may lead to surgery that could have been avoided. By contrast, some ovarian cancers escape the ultrasound and do not present with elevated CA125. Hence, a negative test will reassure women inappropriately.

In December 2015, the world-wide largest ovarian screening study was published and I summarised the trial results in a blog. The UK study enrolled 200,000 menopausal women 50-74 years in one of three screening groups: 1) yearly ultrasounds, 2) ROCA test (including CA125 blood test and transvaginal ultrasound if needed and 3) control group (no screening). 


Whilst the results were to some degree promising, the overall benefit was rather small and there was still a significant proportion of women who developed surgical complications from surgery that could have been avoided. The FDA is concerned about the high false negative and also false positive results. A false negative (the woman does have ovarian cancer but it is not detected through the test) may wrongly assure a woman and cause her not to seek treatments. Similarly, a woman with a false positive (the test indicates an abnormality but the woman does not have ovarian cancer) may undergo unnecessary surgery.The mortality was 0.30% in both screening groups and 0.34% in the no-screening group. Unfortunately, only half of ovarian cancers were detected through screening.

What can women do if they are concerned about their ovarian cancer risk?

The FDA recommends that health professionals consider referring women at high risk for ovarian cancer to a genetic counsellor, gynaecological oncologist, or other specialist to discuss their options.

I realise that some women whose sister, mother, aunt, or other family member developed ovarian or breast cancer are concerned about their own ovarian cancer risk. The FDA identifies women who have reached menopause, women who have a family history of ovarian cancer, and women with the BRCA1 or BRCA2 genetic mutations to have the highest risk for developing ovarian cancer. I would also include women who had treatment for breast cancer in this list.

Ovarian cancer is a serious disease without any early warning signs. Its prognosis is generally poor and I know too many women who get taken away from us too early for ovarian cancer.

My advice to women who are concerned about their ovarian cancer risk is as follows:

  1.  Consider genetic testing: Genetic testing can be done through a blood test. It is the most reliable indicator of your risk for ovarian cancer. Tests are available for $400 at the time of this article. The most cost effective way is to test a patient who developed ovarian, breast or uterine cancer.
  2. If the genetic test indicates that you do have BRCA1, BRCA2 or Lynch syndrome it means that your risk of various cancers is high. You need to see a gynaecological oncologist or a genetic counsellor as soon as possible. There are various options that we can offer you. These options depend on your age and your personal aspirations. Risk-reducing, prophylactic surgery gives you the best chances to survive. Not all options mean that you lose fertility.
  3. If the test does not confirm BRCA1, BRCA2 or Lynch syndrome it could mean one of two things. You are either truly negative and do not carry a mutation and I would assume this if your family history is unremarkable. Or you could carry a mutation that is still not researched or unknown and cannot be tested for. At a conference, which I will attend in October this year, it will be reporting that up to half of all mutations that will cause ovarian cancer cannot be tested for. I know families with a horrendous family history of breast and ovarian cancer who tested negative for BRCA or Lynch. In such circumstances we will need to develop your personal best strategy together.

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  • Andreas Obermair 21/09/2016 11:32am (8 years ago)

    yes, testing has become very affordable at $400. The information gain could be substantial. More recently we have started recommending genetic testing on a wider basis. I would encourage the majority of ovarian cancer patients to have genetic testing.

  • Margaret Mikkelsen 12/09/2016 2:25pm (8 years ago)

    This is very interesting article and has made me think as an ovarian cancer survivor if I should be tested for any of the above genetic tests so I may pass in my results to my daughter and grand daughters

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