Nimesh P. Nagarsheth, MD
Associate Professor of Obstetrics, Gynecology, and Reproductive Science
Icahn School of Medicine at Mount Sinai
Associate Director of Gynecologic Oncology
The Mount Sinai Hospital
The Problem with Ovarian Cancer Screening Tests
The U.S. Food and Drug Administration (FDA) recently issued a warning against the use of products marketed as ovarian cancer screening tests. While these products may be useful in limited scenarios, such as monitoring cancer treatment, the FDA does not want physicians or their patients to be misled into thinking the tests can accurately detect ovarian cancer. The FDA advises against relying on them to guide treatment decisions, because they often provide inaccurate results leading to false diagnoses.
The Need for Effective Ovarian Cancer Screening Tests
Screening for cervical cancer through the use of PAP smears and human papilloma virus tests is a quintessential example of a successful cancer screening program: one that allows doctors to detect cancer early or find a precancerous lesion before it turns into cancer. The medical community is trying to replicate that model for ovarian cancer, a potentially devastating disease usually found at an advanced stage, when it has already spread beyond the pelvis. A successful ovarian cancer screening program would enable us to detect the cancer earlier, when it is localized to the ovary and treatment is more effective.
Tests Are Unproven, Despite Marketing
Extensive research has been conducted in this area, and some of that research has developed into products marketed to physicians as ovarian cancer screening tests. Companies are bringing more and more of these products to market and encouraging physicians to employ them. The most widely used is the CA-125 blood test, which measures a type of protein that is a marker for ovarian cancer. But the bottom line is that, despite all the research and available products, none of them have been shown to be truly effective in detecting ovarian cancer early. Nor have they been demonstrated to improve the survival rate of patients who develop ovarian cancer.
Accept No Substitutes
At this point, these tests are no substitute for guidance based on a patient's history, physical examination, clinical data collected, and judgment of her physician, or for a consultation with a gynecologic oncologist (a doctor who specializes in the diagnosis and treatment of cancers of the female reproductive system). The concern is that these tests often return "false-positive" and "false-negative" results, possibly leading to life-threatening consequences.
For example, a false-positive result indicating a high chance that a lesion is cancerous even though no cancer is present could cause a woman to unnecessarily undergo surgery and possibly end up with a severe surgery-related complication.
A false-negative result can be equally devastating because the patient might actually have a lesion that should cause concern, but if the test shows negative, she might decide against having it removed, and then months later end up with advanced ovarian cancer.
In addition, some women at high risk for developing ovarian cancer, such as those with a significant family history of breast or ovarian cancer or those with the BRCA1 or BRCA2 genetic mutation, may think, falsely, that they are protected when they use these tests to watch for cancer. The FDA is especially concerned that relying on these unproven tests could lead these patients to delay or forgo potentially life-saving preventive treatment, such as surgical removal of the ovaries and fallopian tubes.
Watch for Symptoms
Ovarian cancer is very treatable, even when caught late, but patients who are diagnosed early have significantly better survival rates. Since there are no recommended screening tests, the best way to catch ovarian cancer as early as possible is to be aware of the symptoms and see a doctor if you have any concerns. Unfortunately, the warning signs can be vague and are often missed or mistaken for gastrointestinal ailments.
Here are things to watch for:
• Early satiety--when eating, feeling full sooner than you normally do;
• Unusual bloating and increased abdominal girth;
• Pelvic pain or pressure;
• Nausea while eating.
If a symptom lasts longer than four or five days, do not hesitate to call your physician for advice. In general, pay attention to your body. Know what is normal for you and what is not, so you will recognize when there is a change.
Hopes for Future Screening
We are in the midst of a technological and scientific explosion in medical advancements. That's why I believe there will be effective ways to screen for ovarian cancer in the future, but we are just not there yet. Until that time, use good judgment, have a close relationship with your physician, and consider seeing a gynecologic oncologist if you have any serious concerns about symptoms.