Grade: D The USPSTF recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits
The USPSTF recommends against screening for ovarian cancer in asymptomatic women.This recommendation applies to asymptomatic women who are not known to have a high-risk hereditary cancer syndrome.
Frequency of Service
No information available.
Risk Factor Information
No information available.
Patient Population Under Consideration
This recommendation applies to asymptomatic women who are not known to have a high-risk hereditary cancer syndrome. A hereditary cancer syndrome occurs when a genetic mutation is passed from parent to child that increases risk for developing cancers or can cause earlier onset of cancers. Women who have a hereditary cancer syndrome that puts them at high risk for ovarian cancer are excluded from this recommendation.
Women with certain hereditary cancer syndromes are at high risk for ovarian cancer. For example, women with BRCA1 or BRCA2 genetic mutations associated with hereditary breast and ovarian cancer are at high risk for ovarian cancer. Numerous genetic mutations and hereditary cancer syndromes may be associated with ovarian cancer, each with a different constellation of associated cancers and family history pattern.3-5 Women with a family history of ovarian or breast cancer may be at risk for a hereditary cancer syndrome and should discuss their family history with their health care professional. Management of a diagnosed hereditary cancer syndrome and prevention of ovarian cancer in these women is beyond the scope of this recommendation statement.
The clinical symptoms of ovarian cancer (eg, abdominal pain or pressure, bloating, constipation, urinary symptoms, back pain, or fatigue) are nonspecific and may be present in both healthy women and women with late-stage ovarian cancer; therefore, use of clinical symptoms for risk stratification for the early detection of disease is difficult.
The USPSTF does not recommend routine screening for ovarian cancer using any method. Transvaginal ultrasound and serum CA-125 testing are readily available procedures that are commonly used to evaluate women with signs or symptoms of ovarian cancer, and both have been evaluated in screening studies. Pelvic examination is also commonly performed to evaluate women with lower abdominal symptoms, and although many clinicians perceive that pelvic examination with bimanual palpation of the ovaries is useful for screening for ovarian cancer,6 there is a lack of evidence to support this.7 Furthermore, the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial included bimanual palpation of the ovaries in its initial screening protocol, but this screening component was discontinued 5 years into the study because no cases of ovarian cancer were detected solely with bimanual palpation of the ovaries.8, 9
The evaluation of abnormal test results consists of repeat testing with the same or a different test and often surgical removal (by laparoscopy or laparotomy) of 1 or both of the ovaries and fallopian tubes to determine whether a woman has ovarian cancer. Diagnostic guidelines recommend surgical removal of the complete ovary or ovaries, rather than tissue biopsy, to determine whether ovarian cancer is present.
Treatment of ovarian cancer typically includes surgical treatment (staging or debulking) and intraperitoneal, intravenous, or combined chemotherapy.
In a separate recommendation statement, the USPSTF recommends that women with a family history indicating they are at risk for a deleterious gene mutation (BRCA1 or BRCA2) be referred for genetic counseling and, if indicated, genetic testing.10 The National Cancer Institute provides additional information on ovarian cancer risk and hereditary cancer syndromes.11 The USPSTF also concluded in a separate recommendation statement that the current evidence was insufficient to assess the balance of benefits and harms of screening with pelvic examination to detect a range of gynecologic conditions in asymptomatic, nonpregnant women.7
Research Needs and Gaps
Given that most cases of ovarian cancer are diagnosed at later stages, when associated mortality is high, further research is needed to identify new screening strategies that could accurately detect ovarian cancer early, at a point when outcomes could be improved. There is a need for more sensitive and specific serologic tests, as well as better imaging techniques. Because of the potential for serious harms from diagnostic workup of positive screening results (ie, surgical removal of the ovary to determine whether ovarian cancer is present), new screening strategies should minimize false-positive results and be highly specific. In addition, studies evaluating the benefits and harms of these screening strategies in asymptomatic women not at high risk for ovarian cancer are needed. Study outcomes should include ovarian cancer mortality, quality of life, false-positive rate, surgery rate, surgical complication rate, and psychological harms. Further research is also needed on primary prevention of ovarian cancer.
Update of Previous USPSTF Recommendation
This recommendation statement is consistent with the 2012 USPSTF recommendation.21 Since 2012, the large UKCTOCS trial was published, and much like the PLCO trial, it did not find that screening for ovarian cancer reduces ovarian cancer mortality in asymptomatic women not known to be at high risk for ovarian cancer.
The age-adjusted incidence of ovarian cancer from 2010 to 2014 was 11.4 cases per 100,000 women per year.1 Ovarian cancer is the fifth most common cause of cancer death among US women and the leading cause of death from gynecologic cancer, despite its low incidence.1 Approximately 14,000 women die of ovarian cancer each year in the United States. More than 95% of ovarian cancer deaths occur among women 45 years and older.2
The positive predictive value of screening tests for ovarian cancer is low, and most women with a positive screening test result do not have ovarian cancer (ie, many women without ovarian cancer will have a false-positive result on screening tests).
Benefits of Screening
The USPSTF found adequate evidence that screening with transvaginal ultrasound, testing for the serum tumor marker cancer antigen 125 (CA-125), or a combination of both does not reduce ovarian cancer mortality.
Harms of Screening
The USPSTF found adequate evidence that screening for ovarian cancer can result in important harms, including many false-positive results, which can lead to unnecessary surgical interventions in women who do not have cancer. Depending on the type of screening test used, the magnitude of harm ranges from moderate to substantial and reflects the risk for unnecessary diagnostic surgery. The USPSTF found inadequate evidence on the psychological harms of screening for ovarian cancer.
The USPSTF concludes that there is at least moderate certainty that the harms of screening for ovarian cancer outweigh the benefits.
Recommendations of OthersThere is consensus among major medical and public health organizations that screening for ovarian cancer in the general population is not recommended. The American College of Obstetricians and Gynecologists does not recommend screening for ovarian cancer in low-risk, asymptomatic women; evaluation of high-risk women may include transvaginal ultrasound and CA-125 testing, in addition to physical examination.22 The American Cancer Society states that there is no screening test proven to be effective and sufficiently accurate in the early detection of ovarian cancer and does not recommend screening for ovarian cancer in average-risk women.23 The American College of Radiology does not recommend screening for ovarian cancer in average-risk women.24 Consistent with the USPSTF, the American Academy of Family Physicians recommends against screening for ovarian cancer in asymptomatic women.25 Although it is beyond the scope of the USPSTF recommendation, other organizations, such as the National Comprehensive Cancer Network, have issued guidelines for the prevention of ovarian cancer in women with hereditary cancer syndromes.26