Department of Urology, Erasmus MC, Rotterdam, The Netherlands.
Eur Urol. 2012 Nov;62(5):745-52. doi: 10.1016/j.eururo.2012.05.068. Epub 2012 Jun 7.
Metastatic disease is a major morbidity of prostate cancer (PCa). Its prevention is an important goal.
To assess the effect of screening for PCa on the incidence of metastatic disease in a randomized trial.
DESIGN, SETTING, AND PARTICIPANTS: Data were available for 76,813 men aged 55-69 yr coming from four centers of the European Randomized Study of Screening for Prostate Cancer (ERSPC). The presence of metastatic disease was evaluated by imaging or by prostate-specific antigen (PSA) values >100 ng/ml at diagnosis and during follow-up.
Regular screening based on serum PSA measurements was offered to 36270 men randomized to the screening arm, while no screening was provided to the 40543 men in the control arm.
The Nelson-Aalen technique and Poisson regression were used to calculate cumulative incidence and rate ratios of M+ disease.
After a median follow-up of 12 yr, 666 men with M+ PCa were detected, 256 in the screening arm and 410 in the control arm, resulting in cumulative incidence of 0.67% and 0.86% per 1000 men, respectively (p<0.001). This finding translated into a relative reduction of 30% (hazard ratio [HR]: 0.70; 95% confidence interval [CI], 0.60-0.82; p=0.001) in the intention-to-screen analysis and a 42% (p=0.0001) reduction for men who were actually screened. An absolute risk reduction of metastatic disease of 3.1 per 1000 men randomized (0.31%) was found. A large discrepancy was seen when comparing the rates of M+ detected at diagnosis and all M+ cases that emerged during the total follow-up period, a 50% reduction (HR: 0.50; 95% CI, 0.41-0.62) versus the 30% reduction. The main limitation is incomplete explanation of the lack of an effect of screening during follow-up.
PSA screening significantly reduces the risk of developing metastatic PCa. However, despite earlier diagnosis with screening, certain men still progress and develop metastases. The ERSPC trial is registered under number ISRCTN49127736.
转移性疾病是前列腺癌(PCa)的主要发病率。预防是一个重要的目标。
在随机试验中评估筛查 PCa 对转移性疾病发病率的影响。
设计、地点和参与者:数据可用于来自欧洲前列腺癌筛查随机研究(ERSPC)四个中心的 76813 名 55-69 岁的男性。通过影像学或诊断和随访期间前列腺特异性抗原(PSA)值> 100ng/ml 评估转移性疾病的存在。
定期筛查基于血清 PSA 测量,提供给 36270 名随机分配到筛查组的男性,而 40543 名男性未进行筛查对照组。
采用 Nelson-Aalen 技术和泊松回归计算 M+疾病的累积发病率和发病率比。
中位随访 12 年后,检测到 666 名 M+PCa 男性,筛查组 256 名,对照组 410 名,累积发病率分别为每 1000 名男性 0.67%和 0.86%(p<0.001)。这一发现转化为意向筛查分析中 30%的相对减少(风险比 [HR]:0.70;95%置信区间 [CI],0.60-0.82;p=0.001),实际筛查的男性减少 42%(p=0.0001)。每 1000 名随机分配的男性中,转移性疾病的绝对风险降低了 3.1 例(0.31%)。在比较诊断时和整个随访期间出现的所有 M+病例的检出率时,发现差异很大,降低了 50%(HR:0.50;95%CI,0.41-0.62),而降低了 30%。主要限制是无法解释筛查后随访期间缺乏效果的原因。
PSA 筛查可显著降低发生转移性 PCa 的风险。然而,尽管筛查可早期诊断,但某些男性仍会进展并发生转移。ERSPC 试验在 ISRCTN49127736 下注册。