Objective: Epithelial ovarian cancer kills more women than all other gynecologic malignancies combined because of our inability to detect early-stage disease. Ultrasonography has demonstrated usefulness in the detection of ovarian cancer in asymptomatic women, but its value for the detection of early-stage epithelial ovarian cancer in women of increased risk is uncertain. We examined the usefulness of sonography in the detection of early-stage epithelial ovarian cancer in asymptomatic high-risk women who participated in the National Ovarian Cancer Early Detection Program.
Study design: Only asymptomatic women of increased risk for the development of ovarian cancer with initial normal gynecologic and ultrasound examinations were eligible to participate in the institutional review board-approved National Ovarian Cancer Early Detection Program. Participants underwent comprehensive gynecologic and ultrasound examinations every 6 months. Increased risk includes women with at least 1 affected first-degree relative with ovarian cancer; a personal history of breast, ovarian, or colon cancer; > or =1 affected first- and second-degree relatives with breast and or ovarian cancer; inheritance of a breast cancer mutation from an affected family member, or membership within a recognized cancer syndrome.
Results: The average age of the 4526 women who were evaluated was 46 years; 2610 women were premenopausal, and 1916 women were postmenopausal. A total of 12,709 scans have been performed since 1990. Visualization of both ovaries was noted in 98% of premenopausal and in 94% of postmenopausal women. Fourteen women had undergone unilateral salpingo-oophorectomy. Recall rates at less than the routine 6-month interval were 0.4% in the premenopausal and 0.3% in postmenopausal women. A total of 98 women with persistent adnexal masses were identified, and 49 invasive surgical procedures were performed that diagnosed 37 benign ovarian tumors and 12 gynecologic malignancies. All cancers were detected in asymptomatic women who had normal ultrasound and physical examinations 12 and 6 months before the cancer diagnosis. The detected malignancies were fallopian tube carcinoma (stage IIIC; n = 4 women), primary peritoneal carcinoma (n = 4 women; stage IIIA, 1 woman; stage IIIB, 2 women; stage IIIC, 1 woman), epithelial ovarian cancer (stages IIIA and IIIB; n = 2 women), and endometrial adenocarcinoma (stage IA; n = 2 women). Additionally 37 primary and 12 recurrent breast carcinomas were detected by physical examination. A total of 184 women with genetic predisposition (breast cancer positive) have undergone a prophylactic bilateral salpingo-oophorectomy; 23% of these procedures found atypical hyperplasia, and unexpectedly, 2 women (1%) were found to have stage III (A and B) primary peritoneal carcinoma.
Conclusion: This study demonstrates the limited value of diagnostic ultrasound examination as an independent modality for the detection of early-stage epithelial ovarian cancer in asymptomatic women who are at increased risk for disease.