Background

Results from retrospective studies indicate that selecting individuals for low-dose CT lung cancer screening on the basis of a highly predictive risk model is superior to using criteria similar to those used in the National Lung Screening Trial (NLST; age, pack-year, and smoking quit-time). We designed the Pan-Canadian Early Detection of Lung Cancer (PanCan) study to assess the efficacy of a risk prediction model to select candidates for lung cancer screening, with the aim of determining whether this approach could better detect patients with early, potentially curable, lung cancer.

Methods

We did this single-arm, prospective study in eight centres across Canada. We recruited participants aged 50–75 years, who had smoked at some point in their life (ever-smokers), and who did not have a self-reported history of lung cancer. Participants had at least a 2% 6-year risk of lung cancer as estimated by the PanCan model, a precursor to the validated PLCOm2012 model. Risk variables in the model were age, smoking duration, pack-years, family history of lung cancer, education level, body-mass index, chest x-ray in the past 3 years, and history of chronic obstructive pulmonary disease. Individuals were screened with low-dose CT at baseline (T0), and at 1 (T1) and 4 (T4) years post-baseline. The primary outcome of the study was incidence of lung cancer. This study is registered with ClinicalTrials.gov, number NCT00751660.

Findings

7059 queries came into the study coordinating centre and were screened for PanCan risk. 15 were duplicates, so 7044 participants were considered for enrolment. Between Sept 24, 2008, and Dec 17, 2010, we recruited and enrolled 2537 eligible ever-smokers. After a median follow-up of 5·5 years (IQR 3·2–6·1), 172 lung cancers were diagnosed in 164 individuals (cumulative incidence 0·065 [95% CI 0·055–0·075], incidence rate 138·1 per 10 000 person-years [117·8–160·9]). There were ten interval lung cancers (6% of lung cancers and 6% of individuals with cancer): one diagnosed between T0 and T1, and nine between T1 and T4. Cumulative incidence was significantly higher than that observed in NLST (4·0%; p<0·0001). Compared with 593 (57%) of 1040 lung cancers observed in NLST, 133 (77%) of 172 lung cancers in the PanCan Study were early stage (I or II; p<0·0001).

Interpretation

The PanCan model was effective in identifying individuals who were subsequently diagnosed with early, potentially curable, lung cancer. The incidence of cancers detected and the proportion of early stage cancers in the screened population was higher than observed in previous studies. This approach should be considered for adoption in lung cancer screening programmes.

Funding

Terry Fox Research Institute and Canadian Partnership Against Cancer.

中文翻译：

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通过风险模型筛选参与者以进行肺癌筛查（泛加拿大肺癌早期检测[PanCan]研究）：一项单臂，前瞻性研究

背景

回顾性研究的结果表明，在高度预测的风险模型的基础上选择低剂量CT肺癌筛查的个体优于使用与国家肺部筛查试验（NLST；年龄，包装年限和戒烟时间）。我们设计了全加拿大肺癌早期检测（PanCan）研究，以评估选择肺癌筛查候选者的风险预测模型的功效，目的是确定这种方法是否可以更好地检测出具有早期，可能治愈，肺癌。

方法

我们在加拿大的八个中心进行了这项单臂前瞻性研究。我们招募了50-75岁的参与者，他们一生中曾经吸烟（曾经吸烟），并且没有自我报告的肺癌史。根据PanCan模型（经过验证的PLCOm2012模型的先驱）估计，参与者的6年肺癌风险至少为2％。该模型中的风险变量是年龄，吸烟时间，吸烟年数，肺癌家族史，受教育程度，身体质量指数，过去3年的胸部X光片以及慢性阻塞性肺疾病的病史。在基线（T0），基线后1年（T1）和4年（T4）对低剂量CT进行个体筛查。该研究的主要结果是肺癌的发生率。该研究已在ClinicalTrials.gov上注册。，编号NCT00751660。

发现

7059个查询进入研究协调中心，并进行了PanCan风险筛查。其中15个重复，因此考虑了7044名参与者。在2008年9月24日至2010年12月17日期间，我们招募了2537名符合条件的经常吸烟者，并进行了招募。在平均随访5·5年（IQR 3·2–6·1）后，在164个人中诊断出172例肺癌（累计发生率0·065 [95％CI 0·055-0·075]，发生率每万人年138·1的比率[117·8–160·9]）。间隔有10种肺癌（占肺癌的6％，有癌症的个体占6％）：一种诊断为T0至T1，另一种诊断为T1至T4。累积发生率明显高于NLST（4·0％； p <0·0001）。与在NLST中观察到的1040例肺癌中的593例（57％）相比，PanCan研究中的172例肺癌中有133例（77％）处于早期阶段（I或II；

解释

PanCan模型可以有效地识别随后被诊断出可能治愈的早期肺癌的个体。在筛查的人群中，检测到的癌症发生率和早期癌症的比例高于以前的研究。在肺癌筛查计划中应考虑采用这种方法。

资金

特里·福克斯研究所和加拿大抗癌伙伴关系。