Skip Navigation LinksHome > April 2009 - Volume 113 - Issue 4 > Results From Four Rounds of Ovarian Cancer Screening in a Ra...
Obstetrics & Gynecology:
doi: 10.1097/AOG.0b013e31819cda77
Original Research

Results From Four Rounds of Ovarian Cancer Screening in a Randomized Trial

Partridge, Edward MD1; Kreimer, Aimee R. PhD2; Greenlee, Robert T. MD, MPH3; Williams, Craig BS4; Xu, Jian-Lun PhD2; Church, Timothy R. PhD, MS5; Kessel, Bruce MD6; Johnson, Christine C. PhD, MPH7; Weissfeld, Joel L. MD8; Isaacs, Claudine MD9; Andriole, Gerald L. MD10; Ogden, Sheryl RN, BSN11; Ragard, Lawrence R. MD12; Buys, Saundra S. MD13; for the PLCO Project Team

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Abstract

OBJECTIVE: To test whether annual screening with transvaginal ultrasonography and CA 125 reduces ovarian cancer mortality.

METHODS: Data from the first four annual screens, denoted T0–T3, are reported. A CA 125 value at or above 35 units/mL or an abnormality on transvaginal ultrasonography was considered a positive screen. Diagnostic follow-up of positive screens was performed at the discretion of participants’ physicians. Diagnostic procedures and cancers were tracked and verified through medical records.

RESULTS: Among 34,261 screening arm women without prior oophorectomy, compliance with screening ranged from 83.1% (T0) to 77.6% (T3). Screen positivity rates declined slightly with transvaginal ultrasonography, from 4.6 at T0 to 2.9–3.4 at T1–T3; CA 125 positivity rates (range 1.4–1.8%) showed no time trend. Eighty-nine invasive ovarian or peritoneal cancers were diagnosed; 60 were screen detected. The positive predictive value (PPV) and cancer yield per 10,000 women screened on the combination of tests were similar across screening rounds (range 1.0–1.3% for PPV and 4.7–6.2 for yield); however, the biopsy (surgery) rate among screen positives decreased from 34% at T0 to 15–20% at T1–T3. The overall ratio of surgeries to screen-detected cancers was 19.5:1. Seventy-two percent of screen-detected cases were late stage (III/IV).

CONCLUSION: Through four screening rounds, the ratio of surgeries to screen-detected cancers was high, and most cases were late stage. However, the effect of screening on mortality is as yet unknown.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00002540

LEVEL OF EVIDENCE: II

© 2009 by The American College of Obstetricians and Gynecologists.

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