Andriole GL NEJM 2009

Andriole GL NEJM 2009 - The n e w e ng l a n d j o u r na l...

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original article The new england journal of medicine n engl j med 360;13 nejm.org march 26, 2009 1310 Mortality Results from a Randomized Prostate-Cancer Screening Trial Gerald L. Andriole, M.D., E. David Crawford, M.D., Robert L. Grubb III, M.D., Saundra S. Buys, M.D., David Chia, Ph.D., Timothy R. Church, Ph.D., Mona N. Fouad, M.D., Edward P. Gelmann, M.D., Paul A. Kvale, M.D., Douglas J. Reding, M.D., Joel L. Weissfeld, M.D., Lance A. Yokochi, M.D., Barbara O’Brien, M.P.H., Jonathan D. Clapp, B.S., Joshua M. Rathmell, M.S., Thomas L. Riley, B.S., Richard B. Hayes, Ph.D., Barnett S. Kramer, M.D., Grant Izmirlian, Ph.D., Anthony B. Miller, M.B., Paul F. Pinsky, Ph.D., Philip C. Prorok, Ph.D., John K. Gohagan, Ph.D., and Christine D. Berg, M.D., for the PLCO Project Team* The authors’ affiliations are listed in the Appendix. Address reprint requests to Dr. Berg at the Division of Cancer Preven- tion, National Cancer Institute, National Institutes of Health, 6130 Executive Blvd., Rm. 3112, Bethesda, MD 20892-7346, or at [email protected] *Members of the Prostate, Lung, Colorec- tal, and Ovarian (PLCO) Cancer Screen- ing Trial project team are listed in the Supplementary Appendix, available with the full text of this article at NEJM.org. This article (10.1056/NEJMoa0810696) was published at NEJM.org on March 18, 2009. N Engl J Med 2009;360:1310-9. Copyright © 2009 Massachusetts Medical Society. Abstract Background The effect of screening with prostate-specific–antigen (PSA) testing and digital rectal examination on the rate of death from prostate cancer is unknown. This is the first report from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial on prostate-cancer mortality. Methods From 1993 through 2001, we randomly assigned 76,693 men at 10 U.S. study cen- ters to receive either annual screening (38,343 subjects) or usual care as the control (38,350 subjects). Men in the screening group were offered annual PSA testing for 6 years and digital rectal examination for 4 years. The subjects and health care providers received the results and decided on the type of follow-up evaluation. Usual care sometimes included screening, as some organizations have recommend- ed. The numbers of all cancers and deaths and causes of death were ascertained. Results In the screening group, rates of compliance were 85% for PSA testing and 86% for digital rectal examination. Rates of screening in the control group increased from 40% in the first year to 52% in the sixth year for PSA testing and ranged from 41 to 46% for digital rectal examination. After 7 years of follow-up, the incidence of prostate cancer per 10,000 person-years was 116 (2820 cancers) in the screening group and 95 (2322 cancers) in the control group (rate ratio, 1.22; 95% confidence interval [CI], 1.16 to 1.29). The incidence of death per 10,000 person-years was 2.0 (50 deaths) in the screening group and 1.7 (44 deaths) in the control group (rate ratio, 1.13; 95% CI, 0.75 to 1.70). The data at 10 years were 67% complete and consis-
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Andriole GL NEJM 2009 - The n e w e ng l a n d j o u r na l...

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