Extended Mortality Results for Prostate Cancer Screening in the PLCO Trial With Median Follow-Up of 15 Years
Extended Mortality Results for Prostate Cancer Screening in the PLCO Trial With Median Follow-Up of 15 Years
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DOI：
10.1002/cncr.30474
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发表时间：
2017-02-15
期刊：
影响因子：
6.2
通讯作者：
Andriole, Gerald L.
中科院分区：
文献类型：
--
作者：
Pinsky, Paul F.;Prorok, Philip C.;Andriole, Gerald L.
背景：两项使用前列腺特异性抗原(PSA)的大规模前列腺癌筛查试验在筛查效果方面给出了相互矛盾的结果。其中一项试验，前列腺癌、肺癌、结直肠癌和卵巢癌(PLCO)筛查试验，先前报道了13年的随访结果。这项研究介绍了PLCO试验的最新结果。方法：PLCO试验从1993年到2001年将受试者随机分为干预组或对照组。干预组男性每年接受PSA检查6年，直肠指检4年。这项研究使用了与国家死亡指数相关联的方法，将随机化后的死亡率随访延长至最长19年。结果：男性被随机分为干预组(n=38,340)和对照组(n=38,343)。中位随访期：干预组为14.8年(25/75，12.7/16.5年)，对照组为14.7(25/75，12.6/16.4年)。干预组有255人死于前列腺癌，对照组有244人死于前列腺癌；这意味着比率比(RR)为1.04(95%可信区间[CI]，0.87-1.24)。全因死亡的相对危险度为0.977(95%可信区间，0.950-1.004)。据估计，在试验期间，对照组中86%的男性和干预组中99%的男性接受了PSA测试，估计每年筛查阶段的PSA测试率分别为46%和84%。结论：PLCO试验的中位数超过15年的长期随访仍然表明，与对照组相比，干预组的前列腺癌死亡率没有下降。由于对照臂PSA检测的高比率，这一发现可以被视为显示有组织的筛查与机会性筛查相比没有好处。(C)2016年美国癌症协会。
BACKGROUND: Two large-scale prostate cancer screening trials using prostate-specific antigen (PSA) have given conflicting results in terms of the efficacy of such screening. One of those trials, the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, previously reported outcomes with 13 years of follow-up. This study presents updated findings from the PLCO trial. METHODS: The PLCO trial randomized subjects from 1993 to 2001 to an intervention or control arm. Intervention-arm men received annual PSA tests for 6 years and digital rectal examinations for 4 years. This study used a linkage with the National Death Index to extend mortality follow-up to a maximum of 19 years after randomization. RESULTS: Men were randomized to the intervention arm (n=38,340) or the control arm (n=38,343). The median follow-up time was 14.8 years (25th/75th, 12.7/16.5 years) in the intervention arm and 14.7 years (25th/75th, 12.6/16.4 years) in the control arm. There were 255 deaths from prostate cancer in the intervention arm and 244 deaths from prostate cancer in the control arm; this meant a rate ratio (RR) of 1.04 (95% confidence interval [ CI], 0.87-1.24). The RR for all-cause mortality was 0.977 (95% CI, 0.950-1.004). It was estimated that 86% of the men in the control arm and 99% of the men in the intervention arm received any PSA testing during the trial, and the estimated yearly screening-phase PSA testing rates were 46% and 84%, respectively. CONCLUSIONS: Extended follow-up of the PLCO trial over a median of 15 years continues to indicate no reduction in prostate cancer mortality for the intervention arm versus the control arm. Because of the high rate of control-arm PSA testing, this finding can be viewed as showing no benefit of organized screening versus opportunistic screening. (C) 2016 American Cancer Society.