Description of the Evidence
Compliance with screening ranged from 85% at the initial round to 73% at the sixth round, while contamination in the usual care group ranged from about 3.0% for CA-125 to 4.6% for TVU. Across the first four screening rounds, 11.1% of women had at least one positive test, 8.1% had at least one positive TVU, and 3.4% had at least one positive CA-125 test. The yields of both tests were similar. Ovarian cancer was diagnosed in 212 women (5.7 per 10,000 person-years) in the intervention group and 176 women (4.7 per 10,000 person-years) in the usual care group (rate ratio, 1.21; 95% CI, 0.99–1.48). The stage distributions were similar by study group, with stage III and IV cancers comprising the majority of cases in both the intervention group (163 cases, 77%) and the usual care group (137 cases, 78%). The cancer case treatment distributions were very similar between groups within each stage. There were 118 deaths caused by ovarian cancer (3.1 per 10,000 person-years) in the intervention group and 100 deaths (2.6 per 10,000 person-years) in the usual care group (mortality rate ratio, 1.18; 95% CI, 0.82–1.71). Of the 3,285 women with false-positive results, 1,080 underwent surgical follow-up. Of the 1,080 women who underwent surgical follow-up,163 women experienced at least one serious complication (15%). A total of 1,771 women in the intervention group (7.7%) and 1,304 in the usual care group (5.8%) reported oophorectomy. There were 2,924 deaths due to other causes (excluding ovarian, colorectal, and lung cancer) (76.6 per 10,000 person-years) in the intervention group and 2,914 such deaths (76.2 per 10,000 person-years) in the usual care group (rate ratio, 1.01; 95% CI, 0.96–1.06).[26,27]
Among women in the general U.S. population, simultaneous screening with CA-125 and TVU did not reduce ovarian cancer mortality when compared with usual care.