Screening for Prostate Cancer: Results of the Rotterdam Section of the European Randomized Study of Screening for Prostate Cancer

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• 作者：Monique J. Roobol ; Ries Kranse ; Chris H. Bangma ; Arno G.J.L.H. van Leenders ; Bert G. Blijenberg ; Ron H.N. van Schaik ; Wim J. Kirkels ; Suzie J. Otto ; Theo H. van der Kwast ; Harry J. de Koning ; Fritz H. Schr?der ; the ERSPC Rotterdam study group
• 关键词：Prostate cancer ; Screening ; PSA ; Biopsy ; Mortality
• 刊名：European Urology
• 出版年：2013
• 出版时间：October, 2013
• 年：2013
• 卷：64
• 期：4
• 页码：530-539
• 全文大小：686 K

文摘

Background

Evidence from randomized trials on the effects of screening for prostate cancer (PCa) on disease-specific mortality accumulates slowly with increasing follow-up.

Objective

To assess data on PCa-specific mortality in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer (ERSPC) trial.

Design, setting, and participants

A randomized controlled trial with randomization after signed, written informed consent (efficacy trial). In the period 1993-1999, a total of 42 376 men aged 54-74 yr were randomized to a screening arm (S-arm) (n = 21 210 with screening every 4 yr, applying a total prostate-specific antigen [PSA] level cut-off ¡Ý3.0 ng/ml as biopsy indication) or a control arm (C-arm) (n = 21 166; no intervention).

Outcome measurements and statistical analysis

Number of PCas detected per arm depicted by predefined time periods and prognostic groups. PCa-specific mortality analyses using Poisson regression in age group 55-74 yr at randomization and separately in the predefined age group of 55-69 yr.

Results and limitations

After a median follow-up of 12.8 yr, 19 765 men (94.2 % ) were screened at least once and 2674 PCas were detected (of which 561 [21.0 % ] were interval PCas). In the C-arm, 1430 PCas were detected, resulting in an excess incidence of 59 PCas per 1000 men randomized (61 PCas per 1000 in age group 55-69 yr). Thirty-two percent of all men randomized have died. PCa-specific mortality relative-risk (RR) reductions of 20.0 % overall (age: 55-74 yr; p = 0.042) and 31.6 % (age: 55-69 yr; p = 0.004) were found. A 14.1 % increase was found in men aged 70-74 yr (not statistically significant). Absolute PCa mortality was 1.8 per 1000 men randomized (2.6 per 1000 men randomized in age group 55-69 yr). The number needed to invite and number needed to manage were 565 and 33, respectively, for age group 55-74 yr, and 392 and 24, respectively, for age group 65-69 yr. Given the slow natural history of the disease, follow-up might be too short.

Conclusions

Systematic PSA-based screening reduced PCa-specific mortality by 32 % in the age range of 55-69 yr. The roughly twofold higher incidence in the S-arm underlines the importance of tools to better identify those men who would benefit from screening.