Features and preliminary results of the Dutch centre of the ERSPC (Rotterdam, the Netherlands)

Features and preliminary results of the Dutch centre of the ERSPC (Rotterdam, the Netherlands)
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DOI:
10.1111/j.1464-410x.2003.04390.x
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发表时间:
2003-12-01
期刊:
影响因子:
4.5
通讯作者:
Schröder, FH
Schröder, FH
中科院分区:
医学2区
文献类型:
--
作者:
Roobol, MJ;Kirkels, WJ;Schröder, FH

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目的描述1991年在荷兰和比利时开始的大型前列腺癌筛查多中心研究的荷兰部分的初步结果。材料与方法自1991年开始的一系列5项先导性研究后,1994年开始了以血清前列腺特异性抗原(PSA)测定、直肠指诊(DRE)和经直肠超声(TRUS)为筛查试验的全面筛查。根据结果和使用的筛查方案,男性被转介进行六分活组织检查(如果TRUS显示异常,则延长第七次活组织检查)。描述了使用的方案、不同筛查试验的效率、在试点研究中发现的癌症数量、初始筛查和第二轮筛查的初步结果。结果经过试点研究,明确了在鹿特丹地区进行前列腺癌筛查的研究是可行的。筛选方案可行,招聘率可接受(39.5%)。鹿特丹及其周边城市的人口登记清单和已知的招聘率表明,荷兰中心向ERSPC提供40,000名男子(年龄55-74岁)是可行的。第一轮筛选从1993年12月开始,一直持续到1999年12月(第5-10号议定书)。总共有42376名男性被随机抽样,发现了1,014例癌症(5.1%)。在这一筛选过程中,简化了方案。在评估了不同的筛查试验后,DRE和TRUS的异常结果被省略为六分活检术的指征。现在只有血清PSA水平大于或等于3.0 ng/ml才被用作适应症。第二轮筛选于1997年12月开始,目前仍在继续。到2002年12月,9920名男性在初次筛查4年后进行了第二次筛查。到目前为止,已发现446例癌症(4.5%);这一轮将持续到2003年12月。对筛查方案和检测到的癌症特征的进一步评估在荷兰ERSPC内不断进行。同时,第三轮筛查也已启动,将持续到2007年12月。结论在鹿特丹开展计划规模的前列腺癌筛查研究是可行的,招募比率是可以接受的,筛查试验耐受性良好。这项研究已经产生了许多科学出版物,在确定前列腺癌筛查是否应该成为普通医疗保健的一部分方面将具有重要价值。
Objective To describe the preliminary results of the Dutch section of a large multicentre study of screening for prostate cancer, the European Randomized study of Screening for Prostate Cancer (ERSPC), initiated in the Netherlands and Belgium in 1991.Materials and Methods After a series of five pilot studies which started in 1991, full-capacity screening started in 1994 with the use of a serum prostate-specific antigen (PSA) determination, a digital rectal examination (DRE) and transrectal ultrasonography (TRUS) as screening tests. Depending on the results and the screening protocol used, men were referred for further examination by sextant biopsies (extended with a seventh biopsy if TRUS showed abnormality). The protocols used, efficiency of the different screening tests, number of cancers detected in the pilot studies, initial screening round and preliminary results of the second screening round are described.Results After the pilot studies it became clear that a study of prostate cancer screening was feasible in the Rotterdam area. The screening protocol was workable and the recruitment rate acceptable (39.5%). An inventory of the population registries of Rotterdam and surrounding municipalities, and the known recruitment rate, made it clear that a contribution of 40 000 men (aged 55-74 years) from the Dutch centre to the ERSPC was feasible. The initial screening round started in December 1993 and lasted until December 1999 (protocol 5-10). In all, 42376 men were randomized and 1014 cancers detected (5.1%). During this screening the protocol was simplified. After evaluating the different screening tests abnormal results of the DRE and TRUS were omitted as an indication for a sextant biopsy. Only a serum PSA level of greater than or equal to3.0 ng/mL is now used as the indication. The second screening round started in December 1997 and continues. To December 2002, 9920 men were screened for the second time, 4 years after their initial screening visit. To date 446 cancers have been detected (4.5%); this round will last to December 2003. Further evaluation of the screening regimen and characteristics of the cancers detected are constantly assessed within the Dutch ERSPC. Meanwhile a third screening round has also been initiated, which will last to December 2007.Conclusion A prostate cancer screening study of the projected magnitude is feasible in Rotterdam; the recruitment rate is acceptable and the screening tests well tolerated. The study has generated many scientific publications and will be of great value in determining whether prostate cancer screening should be part of general healthcare.