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Evidence of Benefit
Potential screening tests for ovarian cancer include vaginal ultrasound and the serum cancer antigen (CA) 125 assay. Several biomarkers with potential application to ovarian cancer screening are under development but have not yet been validated or evaluated for efficacy in early detection and mortality reduction.
Bimanual pelvic examination is a part of the routine pelvic examination. The sensitivity and specificity of the pelvic examination are not characterized, but examination generally detects advanced disease.[1,2]
The Pap test may occasionally detect malignant ovarian cells, but it is not sensitive (reported sensitivity of 10%–30%) and has not been evaluated for the early detection of ovarian cancer.[1] Another method of detection, cytologic examination of peritoneal lavage obtained by culdocentesis, is technically difficult, is uncomfortable for the patient, has low sensitivity for detecting early-stage disease, and has not been evaluated for screening.[1,3]
Ultrasonography
Transvaginal ultrasonography (TVU) has been proposed as a screening method for ovarian cancer because of its ability to reliably measure ovarian size and detect small masses.[4] The benefit of ultrasonography for the early detection of ovarian cancer and reduction in mortality has not been evaluated in controlled studies. The Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) is an ongoing randomized clinical trial evaluating the efficacy of annual TVU in combination with CA 125 tests to reduce ovarian cancer mortality. The results of screening on ovarian cancer mortality are not yet available.
An estimate of the false-positive rate associated with screening women aged 55 to 74 years is available from the baseline (prevalent) screening examination of women who participated in the PLCO and who were randomly assigned to be screened with TVU and serum CA 125 concentrations.[5] Among the 39,115 women randomized to the screening arm, 83.4% (28,519) had an initial TVU. Of these, 1,338 (4.7%) had an abnormal TVU examination; 1.9% of examinations were considered inadequate. The following TVU results were classified as abnormal (positive): "ovarian volume greater than 10 cm3; cyst volume greater than 10 cm3; any solid area or papillary projection extending into the cavity of a cystic ovarian tumor of any size; or any mixed (solid/cystic) component within a cystic ovarian tumor."[5] Among women having both the TVU and CA 125 tests (28,506), 1,703 had an abnormal result on at least one test; only 34 were abnormal on both screening tests. About 15% of women with at least one abnormal test did not undergo further evaluation. Of the 29 malignant neoplasms detected by follow-up procedures, 22 had an abnormal TVU. Nine of the neoplasms were of low malignant potential. Of the 21 invasive malignancies diagnosed, only two were stage I. Among women with an abnormal ultrasound, the number of surgeries performed per invasive cancer diagnoses was 41.2. The positive predictive value (PPV) for an abnormal TVU was 1%. This study provides a good assessment of the expected PPV for general population screening compared with programs selectively screening high-risk groups in which the PPV will be higher owing to a higher prevalence of ovarian cancer.
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