Abstract

Context Screening for ovarian cancer with cancer antigen 125 (CA-125) and transvaginal ultrasound has an unknown effect on mortality.Objective To evaluate the effect of screening for ovarian cancer on mortality in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.Design, Setting, and Participants Randomized controlled trial of 78 216 women aged 55 to 74 years assigned to undergo either annual screening (n=39 105) or usual care (n=39 111) at 10 screening centers across the United States between November 1993 and July 2001.Intervention The intervention group was offered annual screening with CA-125 for 6 years and transvaginal ultrasound for 4 years.Participants and their health care practitioners received the screening test results and managed evaluation of abnormal results.The usual care group was not offered annual screening with CA-125 for 6 years or transvaginal ultrasound but received their usual medical care.Participants were followed up for a maximum of 13 years (median [range], 12.4 years [10.9-13.0years]) for cancer diagnoses and death until February 28, 2010. Main Outcome MeasuresMortality from ovarian cancer, including primary peritoneal and fallopian tube cancers.Secondary outcomes included ovarian cancer incidence and complications associated with screening examinations and diagnostic procedures. ResultsOvarian cancer was diagnosed in 212 women (5.7 per 10 000 person-years) in the intervention group and 176 (4.7 per 10 000 person-years) in the usual care group (rate ratio [RR], 1.21; 95% confidence interval [CI], 0.99-1.48).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 RR, 1.18; 95% CI, 0.82-1.71).Of 3285 women with false-positive results, 1080 underwent surgical follow-up; of whom, 163 women experienced at least 1 serious complication (15%).There were 2924 deaths due to other causes (excluding ovarian, colorectal, and lung cancer) (76.6 per 10 000 person-years) in the intervention group and 2914 deaths (76.2 per 10 000 person-years) in the usual care group (RR, 1.01; 95% CI, 0.96-1.06).Conclusions Among women in the general US population, simultaneous screening with CA-125 and transvaginal ultrasound compared with usual care did not reduce ovarian cancer mortality.Diagnostic evaluation following a false-positive screening test result was associated with complications.