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对照组的污染导致基于 PSA 的筛查对 9 年随访时前列腺癌死亡率没有影响:前列腺癌筛查的欧洲随机研究(ERSPC)法国分部的结果。

Contamination in control group led to no effect of PSA-based screening on prostate cancer mortality at 9 years follow-up: Results of the French section of European Randomized Study of Screening for Prostate Cancer (ERSPC).

机构信息

Department of Urology, University Lille, CHU Lille, Lille, France.

Hérault cancer registry, ICM Montpellier, Montpellier, France.

出版信息

Prog Urol. 2020 Apr;30(5):252-260. doi: 10.1016/j.purol.2020.02.011. Epub 2020 Mar 18.

DOI:10.1016/j.purol.2020.02.011
PMID:32197936
Abstract

INTRODUCTION

European Randomized Study of Screening for Prostate Cancer (ERSPC) mortality results were reported for 7 European countries (excluding France) and showed a significant reduction in Prostate cancer (PCa) mortality. As those results have not been part of the global ERSPC results, it is of interest to report PCa mortality at a median follow-up of 9 years for French section of ERSPC.

MATERIAL AND METHODS

Two administrative departments were involved in the study. Only men after randomization in the screening group were invited by mail to be screened by PSA testing with two rounds at 4-6 year intervals. Biopsy was recommended if PSA>=3.0 ng/mL. No information other that the French Association of Urology recommandations on the use of PSA was offered to the control group (own decision of physicians and patients). Follow up was based on cancer registry database. Contamination defined as the receipt of PSA testing in control arm was measured. Poisson regression models were used to estimate the Rate Ratio (RR) of PCa mortality and incidence in the screening vs. control arm.

RESULTS

Starting from 2003, 80,696 men aged 55-69 years were included. The percentage of men in the screening arm with at least one PSA test (compliance) was 31%. Compared to the control arm, PCa incidence increased by 10% in the screening arm (RR=1.10; 95% CI=[1.04-1.16], P=0.001), but PCa mortality did not differ (0.222 and 0.215 deaths/1000 person-years; RR=1.03[0.75-1.42], P=0.9).

DISCUSSION

Limitations include low participation rate. PSA testing in the control arm was observed in 32% of men (contamination).

CONCLUSIONS

Contamination in control group led to no effect of PSA-based screening on prostate cancer mortality at 9 years follow-up.

LEVEL OF EVIDENCE

摘要

引言

欧洲前列腺癌筛查随机研究(ERSPC)的死亡率结果已在 7 个欧洲国家(不包括法国)报告,结果显示前列腺癌(PCa)死亡率显著降低。由于这些结果并非全球 ERSPC 结果的一部分,因此报告 ERSPC 法国分部的中位随访 9 年后的 PCa 死亡率是很有意义的。

材料和方法

本研究涉及两个行政部门。仅对筛查组中随机分组后的男性通过邮寄邀请他们进行两次 PSA 检测,两次检测间隔 4-6 年。如果 PSA≥3.0ng/mL,则建议进行活检。对照组(医生和患者自行决定)没有提供除法国泌尿外科协会推荐使用 PSA 以外的任何信息。随访基于癌症登记数据库。测量了对照组中接受 PSA 检测的污染定义。使用泊松回归模型来估计筛查组与对照组中 PCa 死亡率和发病率的比率比(RR)。

结果

从 2003 年开始,共有 80696 名 55-69 岁的男性入组。筛查组中至少进行过一次 PSA 检测(依从性)的男性比例为 31%。与对照组相比,筛查组的 PCa 发病率增加了 10%(RR=1.10;95%CI=[1.04-1.16],P=0.001),但 PCa 死亡率没有差异(0.222 和 0.215 例/1000 人年;RR=1.03[0.75-1.42],P=0.9)。

讨论

局限性包括参与率低。对照组中有 32%的男性接受了 PSA 检测(污染)。

结论

对照组中的污染导致在 9 年随访中,基于 PSA 的筛查对前列腺癌死亡率没有影响。

证据水平

3。

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