Cumulative Incidence of False-Positive Results in Repeated, Multimodal Cancer Screening

Authors:
  • BKB. S. Kramer
    B. S. Kramer
  • AKA. R. Kreimer
    A. R. Kreimer
  • PPP. C. Prorok
    P. C. Prorok
  • JXJ.-L. Xu
    J.-L. Xu
  • SBS. G. Baker
    S. G. Baker
  • RFR. Fagerstrom
    R. Fagerstrom
  • TRT. L. Riley
    T. L. Riley
  • CBC. D. Berg
    C. D. Berg
  • JGJ. K. Gohagan
    J. K. Gohagan
  • GAG. L. Andriole
    G. L. Andriole
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Abstract
Multiple cancer screening tests have been advocated for the general population; however, clinicians and patients are not always well-informed of screening burdens. We sought to determine the cumulative risk of a false-positive screening result and the resulting risk of a diagnostic procedure for an individual participating in a multimodal cancer screening program. Data were analyzed from the intervention arm of the ongoing Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, a randomized controlled trial to determine the effects of prostate, lung, colorectal, and ovarian cancer screening on disease-specific mortality. The 68,436 participants, aged 55 to 74 years, were randomized to screening or usual care. Women received serial serum tests to detect cancer antigen 125 (CA-125), transvaginal sonograms, posteroanterior-view chest radiographs, and flexible sigmoidoscopies. Men received serial chest radiographs, flexible sigmoidoscopies, digital rectal examinations, and serum prostate-specific antigen tests. Fourteen screening examinations for each sex were possible during the 3-year screening period. After 14 tests, the cumulative risk of having at least 1 false-positive screening test is 60.4% (95% CI, 59.8%-61.0%) for men, and 48.8% (95% CI, 48.1%-49.4%) for women. The cumulative risk after 14 tests of undergoing an invasive diagnostic procedure prompted by a false-positive test is 28.5% (CI, 27.8%-29.3%) for men and 22.1% (95% CI, 21.4%-22.7%) for women. For an individual in a multimodal cancer screening trial, the risk of a false-positive finding is about 50% or greater by the 14th test. Physicians should educate patients about the likelihood of false positives and resulting diagnostic interventions when counseling about cancer screening.

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