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在筛查间隔期发现的前列腺癌男性的疾病特异性生存:随访 11 年后欧洲前列腺癌筛查随机研究-鹿特丹的结果。

Disease-specific survival of men with prostate cancer detected during the screening interval: results of the European randomized study of screening for prostate cancer-Rotterdam after 11 years of follow-up.

机构信息

Department of Urology, Erasmus MC, University Medical Center, Rotterdam, The Netherlands.

出版信息

Eur Urol. 2011 Aug;60(2):330-6. doi: 10.1016/j.eururo.2011.05.013. Epub 2011 May 17.

DOI:10.1016/j.eururo.2011.05.013
PMID:21601352
Abstract

BACKGROUND

In a screening program, interval cancers are cancers diagnosed between two screening visits.

OBJECTIVE

To assess the disease-specific survival (DSS) of men with prostate cancer (PCa) detected during the screening interval.

DESIGN, SETTING, AND PARTICIPANTS: Within the European Randomized Study of Screening for Prostate Cancer section Rotterdam, 42 376 men identified from population registries (55-74 yr of age) were randomized to a screening or control arm. The median follow-up was 11 yr.

INTERVENTION

Men with prostate-specific antigen ≥ 3.0 ng/ml were recommended to undergo lateralized sextant biopsy. The screening interval was 4 yr.

MEASUREMENTS

The disease-specific mortality of men with interval cancers was compared with that of men with PCa in the control arm; the secondary end point was overall mortality. An independent committee determined the causes of death.

RESULTS AND LIMITATIONS

In the screening arm, 139 men were diagnosed with interval cancer of whom 8 died of the disease. In the control arm, the corresponding numbers were 1149 and 128, respectively. When comparing men with interval cancer to men with PCa in the control arm, no statistically significant difference in disease-specific mortality (hazard ratio [HR]:1.12; 95% confidence interval [CI], 0.53-2.36; p = 0.77) and overall mortality (HR: 0.98; 95% CI, 0.68-1.38; p = 0.90) was found, adjusted for age, prognostic factors, and treatment modality. The follow-up is too limited to address the difference in DSS stratified for screening interval.

CONCLUSIONS

In the setting of population-based PCa screening at 4-yr intervals, the DSS of men with interval cancer seems to be similar to that of men with PCa in the control arm. Given that interval cancers contribute significantly to PCa mortality, further benefit in DSS in the screening arm may be achieved by decreasing the occurrence of interval cancer. However, the balance between mortality reduction and overdiagnosis should be preserved.

TRIAL REGISTRATION

ISRCTN49127736.

摘要

背景

在筛查项目中,间期癌是指两次筛查就诊之间诊断出的癌症。

目的

评估在筛查间期发现的前列腺癌(PCa)男性的疾病特异性生存(DSS)。

设计、地点和参与者:在欧洲前列腺癌筛查随机研究(Rotterdam 部分)中,根据人口登记册确定了 42376 名年龄在 55-74 岁的男性,将他们随机分配到筛查组或对照组。中位随访时间为 11 年。

干预措施

前列腺特异性抗原(PSA)≥3.0ng/ml 的男性建议进行侧向六区活检。筛查间隔为 4 年。

测量方法

比较间期癌男性的疾病特异性死亡率与对照组中 PCa 男性的死亡率;次要终点是总死亡率。一个独立的委员会确定了死亡原因。

结果和局限性

在筛查组中,有 139 名男性被诊断为间期癌,其中 8 人死于该病。在对照组中,相应的数字分别为 1149 和 128。将间期癌男性与对照组中 PCa 男性进行比较时,在疾病特异性死亡率(危险比 [HR]:1.12;95%置信区间 [CI],0.53-2.36;p=0.77)和总死亡率(HR:0.98;95% CI,0.68-1.38;p=0.90)方面没有统计学意义的差异,调整了年龄、预后因素和治疗方式。随访时间太短,无法确定筛查间隔分层的 DSS 差异。

结论

在基于人群的每 4 年进行一次 PCa 筛查的情况下,间期癌男性的 DSS 似乎与对照组中 PCa 男性相似。鉴于间期癌对 PCa 死亡率有重要贡献,通过降低间期癌的发生,可能会在 DSS 方面获得进一步的获益。然而,应该在死亡率降低和过度诊断之间保持平衡。

试验注册

ISRCTN49127736。

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