Abstract

To determine the usefulness of sonography in the detection of early-stage ovarian cancer, 4526 asymptomatic women at high risk for ovarian cancer participated in a trial of ultrasound screening. The definition of high risk included 1 or more of the following criteria: 1) at least 1 first-degree relative with ovarian cancer; 2) a personal history of breast or ovarian cancer; 3) multiple first- and second-degree relatives with breast or ovarian cancer; 4) positivity for a BRCA mutation; or 5) a recognized family cancer syndrome. All patients underwent ultrasound examination, serum biomarker analysis, and a comprehensive physical examination at 6-month intervals. All adnexal masses identified with ultrasound were graded as cystic, multiloculated, complex, or solid. Risk of malignancy was determined with a combination of gray-scale morphologic parameters and Doppler investigation. Simple cysts or hemorrhagic-like cysts in premenopausal women were rescanned in 6 to 8 weeks to confirm resolution. In menopausal women, stable, simple, thin-walled masses less than 5 cm with no evidence of central blood flow were rescanned in 2 months and at the 6-month visit to confirm stability. A similar protocol was followed for suspected hydrosalpinges or pelvic adhesive disease. Study subjects were enrollees in the National Ovarian Cancer Early Detection Program (NOCEDP) of the National Institutes of Health. Their average age was 46 years. Since 1990, 4526 women, of whom 2610 were premenopausal and 1916 were postmenopausal, have undergone a total of 12,709 ultrasound scans. Both ovaries could be identified in 98% of premenopausal women and 94% of postmenopausal women, of whom 12.6% and 6.4%, respectively, had cystic masses larger than 2.5 cm. In all, 0.4% of premenopausal and 0.3% of postmenopausal women were referred for reexamination before the usual 6-month visit. Of 98 women with persistent adnexal masses, 44 underwent surgical treatment. Suspicious masses were identified using 3-dimensional ultrasonography to determine the presence of a central vascular flow characteristic of ovarian carcinoma. Twelve women were diagnosed with gynecologic malignancy and 37 with benign conditions. Four primary peritoneal carcinomas, 4 fallopian tube carcinomas, 2 epithelial ovarian carcinomas, and 2 endometrial carcinomas were diagnosed (Table 1). Within the study group, there were 184 subjects who had a BRCA-1 or BRCA-2 mutation and elected to undergo prophylactic bilateral salpingo-oophorectomy. Atypical ovarian or fallopian hyperplasia was found in 23% of these women, and 2 cases of primary peritoneal carcinoma were discovered during preoperative laparoscopy. These 2 women and 2 with cancer of the fallopian tube were BRCA-1. Early-stage breast cancer was detected on physical examination in 37 women, of whom 6 were positive for BRCA-1 or -2.

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