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Original Contribution
June 8, 2011

Effect of Screening on Ovarian Cancer Mortality: The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial

Author Affiliations

Author Affiliations: Huntsman Cancer Institute, University of Utah Health Sciences Center, Salt Lake City (Dr Buys); School of Medicine, University of Alabama, Birmingham (Drs Partridge and Fouad); Epidemiology and Biostatistics Program (Dr Black), Division of Cancer Epidemiology and Genetics (Dr Hartge), Early Detection Research Group, Biometry Research Group, Division of Cancer Prevention (Drs Pinsky, Zhu, Izmirlian, Prorok, and Berg), and Office of Communications and Education (Dr Kramer), National Cancer Institute, Office of Disease Prevention (Dr Gohagan), National Institutes of Health, Bethesda, Maryland; Henry Ford Health System, Detroit, Michigan (Drs Johnson and Lamerato); Lombardi Cancer Center, Georgetown University, Washington, DC (Dr Isaacs); Marshfield Clinic Research Foundation, Marshfield, Wisconsin (Drs Reding and Greenlee); Pacific Health Research and Education Institute, Honolulu, Hawaii (Drs Yokochi and Kessel); Anschutz Cancer Pavilion, University of Colorado, Denver (Dr Crawford); School of Public Health, University of Minnesota, Minneapolis (Dr Church); Division of Urologic Surgery, School of Medicine, Washington University, St Louis, Missouri (Dr Andriole); University of Pittsburgh Medical Center Cancer Pavilion, Pittsburgh, Pennsylvania (Dr Weissfeld); UCLA Immunogenetics Center, Los Angeles, California (Dr Chia); Westat Inc, Rockville, Maryland (Ms O’Brien and Dr Ragard); Information Management Services, Rockville, Maryland (Messrs Clapp, Rathmell, and Riley); and Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada (Dr Miller).

JAMA. 2011;305(22):2295-2303. doi:10.1001/jama.2011.766

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 [10.9-13.0 years]) for cancer diagnoses and death until February 28, 2010.

Main Outcome Measures Mortality 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.

Results Ovarian 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.

Trial Registration clinicaltrials.gov Identifier: NCT00002540