Mortality results from a randomized prostate-cancer screening trial.
Mortality results from a randomized prostate-cancer screening trial.
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DOI：
10.1056/nejmoa0810696
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发表时间：
2009-03-26
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影响因子：
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通讯作者：
PLCO Project Team
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作者：
Andriole GL;Crawford ED;Grubb RL 3rd;Buys SS;Chia D;Church TR;Fouad MN;Gelmann EP;Kvale PA;Reding DJ;Weissfeld JL;Yokochi LA;O'Brien B;Clapp JD;Rathmell JM;Riley TL;Hayes RB;Kramer BS;Izmirlian G;Miller AB;Pinsky PF;Prorok PC;Gohagan JK;Berg CD;PLCO Project Team
前列腺特异性抗原（PSA）检测和直肠指检筛查对前列腺癌死亡率的影响尚不清楚。这是前列腺癌、肺癌、结直肠癌和卵巢癌（PLCO）筛查试验关于前列腺癌死亡率的第一份报告。从1993年到2001年，我们在美国10个研究中心随机分配了76，693名男性接受年度筛查（38，343名受试者）或常规护理作为对照（38，350名受试者）。筛查组的男性每年接受PSA检测6年，直肠指检4年。受试者和卫生保健提供者收到结果，并决定后续评估的类型。正如一些组织所建议的那样，产前护理有时包括筛查。所有癌症和死亡人数以及死亡原因都已查明。在筛查组中，PSA检测的依从率为85%，直肠指检的依从率为86%。对照组的PSA检测筛查率从第一年的40%增加到第六年的52%，直肠指检筛查率从41%增加到46%。7年随访后，筛查组每10,000人年的前列腺癌发病率为116例（2820例癌症），对照组为95例（2322例癌症）（率比为1.22; 95%置信区间[CI]为1.16 ~ 1.29）。筛查组的死亡率为2.0/10，000人-年（50例死亡），对照组为1.7/10，000人-年（44例死亡）（率比为1.13; 95%CI为0.75 ~ 1.70）。10年时的数据完成率为67%，与这些总体结果一致。经过7到10年的随访，前列腺癌的死亡率非常低，两个研究组之间没有显著差异。
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. From 1993 through 2001, we randomly assigned 76,693 men at 10 U.S. study centers 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 recommended. The numbers of all cancers and deaths and causes of death were ascertained. 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 consistent with these overall findings. After 7 to 10 years of follow-up, the rate of death from prostate cancer was very low and did not differ significantly between the two study groups.