The UK Lung Cancer Screening Trial: a pilot randomised controlled trial of low-dose computed tomography screening for the early detection of lung cancer
The UK Lung Cancer Screening Trial: a pilot randomised controlled trial of low-dose computed tomography screening for the early detection of lung cancer
复制标题
DOI：
10.3310/hta20400
复制
发表时间：
2016-05-01
影响因子：
3.6
通讯作者：
Hansell, David M.
中科院分区：
文献类型：
--
作者：
Field, John K.;Duffy, Stephen W.;Hansell, David M.
背景：在英国，肺癌死亡人数超过任何其他癌症（5年生存率< 13%）。早期诊断可以挽救生命。美国国家肺癌筛查试验报告低剂量CT（LDCT）筛查受试者肺癌死亡率和全因死亡率相对降低20%和6.7%。目的：（1）分析英国高危人群LDCT肺癌筛查，确定最佳招募、筛查、阅读和护理路径策略;评估筛查的心理后果和健康经济学意义。设计：一项初步随机对照试验，比较干预与常规护理。一项基于人群的风险问卷调查确定了患肺癌的高危人群（5年以上>= 5%）。设置：具有肺癌成像、呼吸内科、病理学和外科专业知识的胸外科中心：默西塞德郡的利物浦心胸医院和剑桥郡的Papworth医院。参与者：50-75岁的肺癌高危人群，在中心附近的初级保健信托中。干预措施：胸部LDCT扫描。按照方案进行随访计算机断层扫描（CT）。转诊到多学科团队诊所是根据结节大小标准确定的。主要结果测量：基于危险分层的人群招募;通过基于网络的数据库管理试验; CT扫描阅片者的最佳特征（放射科医师与放射技师）;利用容积分析表征CT检测到的结节;基线时肺癌患病率;影响参与的社会人口因素;心理社会措施（癌症困扰，焦虑，抑郁，决策满意度）;和成本效益modeling.Results：共247,354人参加了试验; 30.7%的人积极响应筛选邀请。招募的参与者中，CT组2028人，对照组2027人。2.1%被诊断为肺癌; 42例筛查发现的癌症中有36例（85.7%）被确定为1期或2期，35例（83.3%）接受手术切除作为主要治疗。肺癌在社会经济地位最低的群体中更为常见。在随机分配到干预组的参与者和检测到重大肺部异常的参与者中观察到短期不良心理社会后果，但这些差异是适度和暂时的。将筛查作为一项服务推出或设计一项完整的审判需要解决外联问题。健康经济分析表明，干预可能是具有成本效益的，但这需要确认使用数据的实际肺癌mortality.Conclusions：英国肺癌筛查（UKLS）试点成功进行了4055随机个体。来自UKLS的数据提供的证据增加了现有数据，表明英国的肺癌筛查可能在60-75岁年龄组中实施，通过利物浦肺项目风险模型第2版选择，并使用基于CT体积的管理方案。（荷兰鲁汶Longkanker筛查Onderzoek：荷兰-比利时随机肺癌筛查试验）和其他欧盟试验，这些试验将提供欧洲死亡率和成本效益数据。目前，显然需要其他试验的死亡率结果和进一步的研究，以确定实施和交付的最佳方法。提高接受率和向得不到充分服务的群体提供支助的战略将是执行工作的关键。
Background: Lung cancer kills more people than any other cancer in the UK (5-year survival < 13%). Early diagnosis can save lives. The USA-based National Lung Cancer Screening Trial reported a 20% relative reduction in lung cancer mortality and 6.7% all-cause mortality in low-dose computed tomography (LDCT)-screened subjects.Objectives: To (1) analyse LDCT lung cancer screening in a high-risk UK population, determine optimum recruitment, screening, reading and care pathway strategies; and (2) assess the psychological consequences and the health-economic implications of screening.Design: A pilot randomised controlled trial comparing intervention with usual care. A population-based risk questionnaire identified individuals who were at high risk of developing lung cancer (>= 5% over 5 years).Setting: Thoracic centres with expertise in lung cancer imaging, respiratory medicine, pathology and surgery: Liverpool Heart & Chest Hospital, Merseyside, and Papworth Hospital, Cambridgeshire.Participants: Individuals aged 50-75 years, at high risk of lung cancer, in the primary care trusts adjacent to the centres.Interventions: A thoracic LDCT scan. Follow-up computed tomography (CT) scans as per protocol. Referral to multidisciplinary team clinics was determined by nodule size criteria.Main outcome measures: Population-based recruitment based on risk stratification; management of the trial through web-based database; optimal characteristics of CT scan readers (radiologists vs. radiographers); characterisation of CT-detected nodules utilising volumetric analysis; prevalence of lung cancer at baseline; sociodemographic factors affecting participation; psychosocial measures (cancer distress, anxiety, depression, decision satisfaction); and cost-effectiveness modelling.Results: A total of 247,354 individuals were approached to take part in the trial; 30.7% responded positively to the screening invitation. Recruitment of participants resulted in 2028 in the CT arm and 2027 in the control arm. A total of 1994 participants underwent CT scanning: 42 participants (2.1%) were diagnosed with lung cancer; 36 out of 42 (85.7%) of the screen-detected cancers were identified as stage 1 or 2, and 35 (83.3%) underwent surgical resection as their primary treatment. Lung cancer was more common in the lowest socioeconomic group. Short-term adverse psychosocial consequences were observed in participants who were randomised to the intervention arm and in those who had a major lung abnormality detected, but these differences were modest and temporary. Rollout of screening as a service or design of a full trial would need to address issues of outreach. The health-economic analysis suggests that the intervention could be cost-effective but this needs to be confirmed using data on actual lung cancer mortality.Conclusions: The UK Lung Cancer Screening (UKLS) pilot was successfully undertaken with 4055 randomised individuals. The data from the UKLS provide evidence that adds to existing data to suggest that lung cancer screening in the UK could potentially be implemented in the 60-75 years age group, selected via the Liverpool Lung Project risk model version 2 and using CT volumetry-based management protocols.Future work: The UKLS data will be pooled with the NELSON (Nederlands Leuvens Longkanker Screenings Onderzoek: Dutch-Belgian Randomised Lung Cancer Screening Trial) and other European Union trials in 2017 which will provide European mortality and cost-effectiveness data. For now, there is a clear need for mortality results from other trials and further research to identify optimal methods of implementation and delivery. Strategies for increasing uptake and providing support for underserved groups will be key to implementation.