Published at www.nejm.org March 18, 2009 (10.1056/NEJMoa0810084)
Screening and Prostate-Cancer Mortality in a Randomized European Study
Fritz H. Schröder, M.D., Jonas Hugosson, M.D., Monique J. Roobol, Ph.D., Teuvo L.J. Tammela, M.D., Stefano Ciatto, M.D., Vera Nelen, M.D., Maciej Kwiatkowski, M.D., Marcos Lujan, M.D., Hans Lilja, M.D., Marco Zappa, Ph.D., Louis J. Denis, M.D., Franz Recker, M.D., Antonio Berenguer, M.D., Liisa Määttänen, Ph.D., Chris H. Bangma, M.D., Gunnar Aus, M.D., Arnauld Villers, M.D., Xavier Rebillard, M.D., Theodorus van der Kwast, M.D., Bert G. Blijenberg, Ph.D., Sue M. Moss, Ph.D., Harry J. de Koning, M.D., Anssi Auvinen, M.D., for the ERSPC Investigators
Editor's note: Do the benefits of PSA screening outweigh therisks? Watch video of a roundtable discussion, participate ina poll, and contribute your comments in our Clinical Directionsfeature — Screening for Prostate Cancer. Commenting closesApril 1, 2009.
ABSTRACT
Background The European Randomized Study of Screening for ProstateCancer was initiated in the early 1990s to evaluate the effectof screening with prostate-specific–antigen (PSA) testingon death rates from prostate cancer.
Methods We identified 182,000 men between the ages of 50 and74 years through registries in seven European countries forinclusion in our study. The men were randomly assigned to agroup that was offered PSA screening at an average of once every4 years or to a control group that did not receive such screening.The predefined core age group for this study included 162,243men between the ages of 55 and 69 years. The primary outcomewas the rate of death from prostate cancer. Mortality follow-upwas identical for the two study groups and ended on December31, 2006.
Results In the screening group, 82% of men accepted at leastone offer of screening. During a median follow-up of 9 years,the cumulative incidence of prostate cancer was 8.2% in thescreening group and 4.8% in the control group. The rate ratiofor death from prostate cancer in the screening group, as comparedwith the control group, was 0.80 (95% confidence interval [CI],0.65 to 0.98; adjusted P=0.04). The absolute risk differencewas 0.71 death per 1000 men. This means that 1410 men wouldneed to be screened and 48 additional cases of prostate cancerwould need to be treated to prevent one death from prostatecancer. The analysis of men who were actually screened duringthe first round (excluding subjects with noncompliance) provideda rate ratio for death from prostate cancer of 0.73 (95% CI,0.56 to 0.90).
Conclusions PSA-based screening reduced the rate of death fromprostate cancer by 20% but was associated with a high risk ofoverdiagnosis. (Current Controlled Trials number, ISRCTN49127736
[controlled-trials.com]
.)
Source Information
The authors' affiliations are listed in the Appendix. This article (10.1056/NEJMoa0810084) was published at NEJM.org on March 18, 2009. It will appear in the March 26 issue of the Journal.
Address reprint requests to Dr. Schröder at the Erasmus Medical Center, P.O. Box 2040, Rotterdam 3000 CA, the Netherlands, or at secr.schroder{at}erasmusmc.nl.
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