Since 1987 more than 14,000 women older than 50 years, or older than 25 years with a family history of ovarian cancer, have participated in the University of Kentucky Ovarian Cancer Screening Project. In this program, asymptomatic women were screened with annual sonograms to investigate the ability of annual transvaginal sonography to detect early ovarian cancer. At each annual visit, participants who had an ovarian volume of more than 10 cm3in postmenopausal women, more than 20 cm3in menopausal women, or papillary or complex tissue projection into a cystic ovarian tumor underwent repeated sonography within 4 to 6 weeks. If the abnormality persisted, serum cancer antigen 125 (CA-125) levels were measured, and tumor morphology indexing and Doppler flow sonography were performed. At this point, the women were advised to have surgical removal of the tumor.Of the 14,469 women enrolled in this project, 180 (1.2 percent) have undergone surgery for removal of an ovarian tumor. Total abdominal hysterectomy with bilateral oophorectomy was performed in patients with ovarian cancer or who had other indications for hysterectomy. Women with benign tumors usually had only unilateral or bilateral salpingo-oophorectomy. Serous cystadenoma was the most frequent diagnosis (in 78 of 180 women), followed by endometrioma (25 of 180). Primary ovarian cancer was found in 17 of the 180 patients. A significant difference was seen between the mean morphology index of benign tumors and malignant tumors (benigncolon; mean equals; 3.8, SD equals; 2.4, range equals; 0ndash;12; malignantcolon; mean equals; 6.0, SD equals; 2.4, range equals; 2ndash;10; P .001). No cancer was found in unilocular tumors without wall abnormalities (Nequals; 94). Family history of ovarian cancer was not associated with the diagnosis of ovarian cancer or cystadenoma.Eleven of the 17 ovarian cancers were stage I, 3 were stage II, and 3 were stage III. Serum levels of CA-125 were measured in 7 of the 11 stage I patients; the level of CA-125 was elevated in only 1. Nine of the cancers were found during the first screening; the other eight were detected at subsequent screenings. With 1 to 10 years of follow-up, 15 patients are disease free. Two patients, one with stage IIIB disease and one with stage IIIC disease, have died of ovarian cancer. In both cases the cancer was detected at the first screening and treated aggressively. One patient lived for more than 7 years after her initial diagnosis, and the other lived nearly 2.5 years after diagnosis.In four women ovarian cancer developed within 1 year of a negative transvaginal sonogram. In two of these patients, the ovaries could not be visualized and were classified as negative according to study protocol. The other two patients had normal-sized ovaries at screening, and normal-sized ovaries with normal morphologic characteristics were found on surgical exploration nearly 1 year later. They were diagnosed with stage IIA and stage IIIB disease. Three of the four patients had elevated serum CA-125 levels, and one had a palpable mass on clinical examination. Three women are alive with no evidence of disease 0.4 to 5.7 years after diagnosis, and one died within 1 year of diagnosis.In four other women, who had missed their scheduled yearly screenings, ovarian cancer developed 14 to 47 months after their last sonogram. All four were diagnosed with stage III disease. Two are alive with no evidence of disease at 1.5 and 2.1 years after diagnosis, and two died of ovarian cancer.Over the course of the study, 215 of the 14,469 participants have undergone hysterectomy for other reasons. No ovarian abnormalities were seen in these patients. Defining the 163 women who underwent surgery for benign ovarian abnormalities as false positive and the four women who developed ovarian cancer within 1 year of a negative screen as false negative, annual transvaginal sonography screening has a sensitivity of 0.810 and a specificity of 0.989 for detecting ovarian cancer with a positive predictive value of 0.094 and a negative predictive value of 0.999. There rate of survival was 95 plusmn; 4.9 percent at 2 years and 88 plusmn; 8.0 percent at 5 years for the group of women who underwent annual screening. The 2- and 5-year survival rates for the annually screened group are 95 plusmn; 4.9 percent and 88.2 plusmn; 8.0 percent, respectively. Including the patients who had irregular screening and were diagnosed clinically, 2- and 5-year survival rates were 91.3 plusmn; 6.0 and 79.32 plusmn; 9.5 percent, respectively.Gynecol Oncol 2000;77colon;350ndash;356
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