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西班牙部分的欧洲前列腺癌筛查随机研究(ERSPC)结果。 21 年随访后的更新。

Results of the spanish section of the European Randomized Study of Screening for Prostate Cancer (ERSPC). Update after 21 years of follow-up.

机构信息

Unidad de Urología, Hospital Universitario Infanta Cristina, Parla, Madrid, España.

Servicio de Urología, Hospital Universitario de Fuenlabrada, Fuenlabrada, Madrid, España.

出版信息

Actas Urol Esp (Engl Ed). 2020 Jul-Aug;44(6):430-436. doi: 10.1016/j.acuro.2020.01.005. Epub 2020 Mar 5.

DOI:10.1016/j.acuro.2020.01.005
PMID:32147352
Abstract

INTRODUCTION AND OBJECTIVE

The objective of the European Randomized Study of Screening for Prostate Cancer (ERSPC) is to assess whether prostate cancer (PCa) screening leads to an improvement of cancer-specific survival. This multicenter study (eight European countries) has recruited more than 180,000 asymptomatic men. After a follow-up period of 16 years, it has been shown that PSA screening reduces PCa mortality by 20%, and that it does not affect all-cause mortality. This article provides updated the results of the Spanish arm of the ERSPC after 21 years of follow-up.

MATERIALS AND METHODS

The study invited 18,612 men (aged 45 - 70) of the Spanish section (Getafe and Parla, Madrid) to participate. They were randomly assigned to the intervention arm (serum PSA-based screening) and to the control arm (follow-up without intervention). The diagnoses of PCa were recorded, as well as the PCa-specific and all-cause mortality rates. A comparison between the survival curves of both arms of the study and detailed analysis of the causes of death were performed.

RESULTS

The study finally included 4,276 men (2,415 intervention arm, 1,861 control arm). The median age, serum PSA and follow-up time were 57 years, 0.9 ng/ml and 21.1 years, respectively. There were 285 cases with PCa diagnosis, 188 (7.8%) from the intervention arm and 97 (5.2%) from the control arm (p<,001). A total of 216 (75.8%) presented organ-confined disease. There were 994 deaths were recorded; 544 (22.5%) in the intervention arm and 450 (24.2%) in the control arm. No significant differences were detected between the arms of the study in terms of cancer-specific (p=.768) or all-cause (p=.192) mortality rates. The main cause of death was malignant tumors (492 patients, 49.5% of overall mortality), and the most frequent sites were lung and bronchus (29.5%), colon and rectum (14.8%), and hematologic (9.8%). Only 20 patients (0.4% of the patients recruited) died from PCa, with no significant difference between study arms.

CONCLUSIONS

In this update of the results of the Spanish section of the ERSPC study after 21 years of follow-up, we have not detected a benefit of PCa screening in terms of overall and cancer-specific survival.

摘要

简介和目的

欧洲前列腺癌筛查随机研究(ERSPC)的目的是评估前列腺癌(PCa)筛查是否能提高癌症特异性生存率。这项多中心研究(涉及 8 个欧洲国家)招募了超过 180,000 名无症状男性。经过 16 年的随访,研究表明 PSA 筛查降低了 20%的 PCa 死亡率,但不会影响全因死亡率。本文提供了西班牙 ERSPC 臂经过 21 年随访后的最新结果。

材料和方法

该研究邀请了西班牙部分(马德里的 Getafe 和 Parla)的 18,612 名男性(年龄 45-70 岁)参加。他们被随机分配到干预组(基于血清 PSA 的筛查)和对照组(无干预随访)。记录了 PCa 的诊断情况,以及 PCa 特异性和全因死亡率。对研究中两个臂的生存曲线进行了比较,并对死亡原因进行了详细分析。

结果

该研究最终纳入了 4,276 名男性(干预组 2,415 名,对照组 1,861 名)。中位年龄、血清 PSA 和随访时间分别为 57 岁、0.9ng/ml 和 21.1 年。共有 285 例诊断为 PCa,其中干预组 188 例(7.8%),对照组 97 例(5.2%)(p<0.001)。共有 216 例(75.8%)为器官局限性疾病。共记录了 994 例死亡;干预组 544 例(22.5%),对照组 450 例(24.2%)。研究组之间在癌症特异性(p=0.768)或全因死亡率(p=0.192)方面无显著差异。主要死亡原因是恶性肿瘤(492 例,占总死亡率的 49.5%),最常见的部位是肺和支气管(29.5%)、结肠和直肠(14.8%)和血液学(9.8%)。只有 20 名患者(招募患者的 0.4%)死于 PCa,两组间无显著差异。

结论

在这项经过 21 年随访的 ERSPC 研究西班牙部分结果的更新中,我们没有发现 PCa 筛查在整体和癌症特异性生存方面的获益。

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