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欧洲开展有组织的低剂量螺旋CT肺癌筛查项目的艰难之路。

The narrow path to organized LDCT lung cancer screening programs in Europe.

作者信息

Paci Eugenio

机构信息

Epidemiologist, ISPO - Cancer Prevention and Research Institute, Florence, Italy.

出版信息

J Thorac Dis. 2018 Jul;10(7):4556-4564. doi: 10.21037/jtd.2018.07.08.

Abstract

A recent position statement by a group of European experts reviewed the current evidence for low-dose computed tomography (LDCT) lung cancer screening, based on the outcomes and screening performance of the published randomized trials and identified actions needed for eventual future implementation. After the National Lung Screening Trial (NLST) outcome publication, guidelines changed in USA and Canada, but there are still problems in real-world screening practice. In Europe any decision was postponed to the publication of the European randomized trial outcomes and recommendations continue to discourage screening for lung cancer in all member countries. The NELSON randomized controlled trial (RCT), the largest one in Europe, outcome results are still waited, whereas the MILD, DANTE, DLSCT and ITALUNG (all with small sample size) RCTs have published mortality and incidence data with adequate follow up. The implementation of an organized screening in Europe is conditioned by a health technology assessment process at European level. According with the European policy, confirmed in the recent European Cancer Code [2015], screening is transferred in current public-health practice according with evidence-based recommendations and based on organized, usually population-based, programs. Guidelines, standard indicators of performance, training of dedicated radiologists and professionals and a comprehensive quality assurance system is requested in European countries to implement nationally a public health screening program. Waiting the NELSON randomized trial results, key issues as modality for selection of high risk subjects and recruitment, integration of screening and smoking cessation, optimal screening regimen and related research on biomarkers should be assessed, discussed and reviewed. Informed decision making, promotion of primary prevention and integration of screening and smoking cessation are all essential components of a comprehensive risk reduction policy. The path to an Evidence-based screening practice is narrow and, in the absence of a well-established decision-making process, the risk of a spontaneous, uncontrolled use of LDCT screening or, on the other side, an oversight of the screening opportunity is high.

摘要

一组欧洲专家最近发表的立场声明,基于已发表的随机试验的结果和筛查表现,对低剂量计算机断层扫描(LDCT)肺癌筛查的现有证据进行了审查,并确定了未来最终实施所需采取的行动。美国国立肺癌筛查试验(NLST)结果公布后,美国和加拿大的相关指南发生了变化,但在实际的筛查实践中仍存在问题。在欧洲,任何决策都被推迟到欧洲随机试验结果公布,并且相关建议仍不鼓励所有成员国进行肺癌筛查。欧洲最大的随机对照试验(RCT)——荷兰-比利时肺癌筛查试验(NELSON)的结果仍未公布,而轻度肺癌筛查试验(MILD)、肺癌筛查剂量评估试验(DANTE)、低剂量螺旋CT肺癌筛查试验(DLSCT)和意大利肺癌筛查试验(ITALUNG,样本量均较小)已经公布了经过充分随访后的死亡率和发病率数据。在欧洲实施有组织的筛查取决于欧洲层面的卫生技术评估过程。根据最近的《欧洲癌症法典》(2015年)所确认的欧洲政策,筛查应依据循证建议并基于有组织的、通常是基于人群的项目,转化为当前的公共卫生实践。欧洲国家要在全国范围内实施公共卫生筛查项目,需要指南、标准的性能指标、对专业放射科医生和专业人员的培训以及全面的质量保证体系。在等待NELSON随机试验结果期间,应评估、讨论和审查一些关键问题,如高危人群的选择方式和招募、筛查与戒烟的整合、最佳筛查方案以及生物标志物的相关研究。知情决策、促进一级预防以及筛查与戒烟的整合都是全面降低风险政策的重要组成部分。循证筛查实践之路狭窄,在缺乏完善决策过程的情况下,自发、无控制地使用LDCT筛查的风险很高,或者另一方面,错过筛查机会的风险也很高。

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