Department of Urology, Erasmus MC, University Medical Centre, Rotterdam, The Netherlands.
Eur Urol. 2009 Oct;56(4):584-91. doi: 10.1016/j.eururo.2009.07.018. Epub 2009 Jul 28.
Prostate-specific antigen (PSA) based screening for prostate cancer (PCa) has been shown to reduce prostate specific mortality by 20% in an intention to screen (ITS) analysis in a randomised trial (European Randomised Study of Screening for Prostate Cancer [ERSPC]). This effect may be diluted by nonattendance in men randomised to the screening arm and contamination in men randomised to the control arm.
To assess the magnitude of the PCa-specific mortality reduction after adjustment for nonattendance and contamination.
DESIGN, SETTING, AND PARTICIPANTS: We analysed the occurrence of PCa deaths during an average follow-up of 9 yr in 162,243 men 55-69 yr of age randomised in seven participating centres of the ERSPC. Centres were also grouped according to the type of randomisation (ie, before or after informed written consent).
Nonattendance was defined as nonattending the initial screening round in ERSPC. The estimate of contamination was based on PSA use in controls in ERSPC Rotterdam.
Relative risks (RRs) with 95% confidence intervals (CIs) were compared between an ITS analysis and analyses adjusting for nonattendance and contamination using a statistical method developed for this purpose.
In the ITS analysis, the RR of PCa death in men allocated to the intervention arm relative to the control arm was 0.80 (95% CI, 0.68-0.96). Adjustment for nonattendance resulted in a RR of 0.73 (95% CI, 0.58-0.93), and additional adjustment for contamination using two different estimates led to estimated reductions of 0.69 (95% CI, 0.51-0.92) to 0.71 (95% CI, 0.55-0.93), respectively. Contamination data were obtained through extrapolation of single-centre data. No heterogeneity was found between the groups of centres.
PSA screening reduces the risk of dying of PCa by up to 31% in men actually screened. This benefit should be weighed against a degree of overdiagnosis and overtreatment inherent in PCa screening.
基于前列腺特异性抗原（PSA）的前列腺癌（PCa）筛查在一项随机试验（欧洲前列腺癌筛查随机研究[ERSPC]）的意向筛查（ITS）分析中显示可降低 20%的前列腺特异性死亡率。这种效果可能会因分配到筛查组的男性不参加筛查以及分配到对照组的男性受到污染而减弱。
评估在调整不参加和污染因素后，PCa 特异性死亡率降低的幅度。
设计、地点和参与者：我们分析了在 ERSPC 中，162243 名 55-69 岁男性在平均 9 年的随访中发生的 PCa 死亡病例。根据随机分组的类型（即知情书面同意之前或之后），这些中心还分为两组。
不参加被定义为未参加 ERSPC 的初始筛查轮次。污染的估计值基于 ERSPC 鹿特丹中心对照组中 PSA 的使用。
采用为此目的开发的统计方法，比较 ITS 分析与调整不参加和污染因素后的分析之间的相对风险（RR）及其 95%置信区间（CI）。
在 ITS 分析中，与对照组相比，分配到干预组的男性 PCa 死亡的 RR 为 0.80（95%CI，0.68-0.96）。调整不参加因素后，RR 为 0.73（95%CI，0.58-0.93），使用两种不同估计值进一步调整污染因素后，RR 分别估计为 0.69（95%CI，0.51-0.92）和 0.71（95%CI，0.55-0.93）。污染数据是通过单中心数据外推获得的。未发现中心组之间存在异质性。
PSA 筛查可将实际筛查男性死于 PCa 的风险降低多达 31%。这种益处应与 PCa 筛查固有的一定程度的过度诊断和过度治疗相权衡。
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