Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, Maryland.
School of Medicine, Nottingham University Hospitals and the University of Nottingham, Nottingham, United Kingdom.
JAMA Netw Open. 2023 Mar 1;6(3):e233273. doi: 10.1001/jamanetworkopen.2023.3273.
Annual low-dose computed tomographic (LDCT) screening reduces lung cancer mortality, but harms could be reduced and cost-effectiveness improved by reusing the LDCT image in conjunction with deep learning or statistical models to identify low-risk individuals for biennial screening.
To identify low-risk individuals in the National Lung Screening Trial (NLST) and estimate, had they been assigned a biennial screening, how many lung cancers would have been delayed 1 year in diagnosis.
DESIGN, SETTING, AND PARTICIPANTS: This diagnostic study included participants with a presumed nonmalignant lung nodule in the NLST between January 1, 2002, and December 31, 2004, with follow-up completed on December 31, 2009. Data were analyzed for this study from September 11, 2019, to March 15, 2022.
An externally validated deep learning algorithm that predicts malignancy in current lung nodules using LDCT images (Lung Cancer Prediction Convolutional Neural Network [LCP-CNN]; Optellum Ltd) was recalibrated to predict 1-year lung cancer detection by LDCT for presumed nonmalignant nodules. Individuals with presumed nonmalignant lung nodules were hypothetically assigned annual vs biennial screening based on the recalibrated LCP-CNN model, Lung Cancer Risk Assessment Tool (LCRAT + CT [a statistical model combining individual risk factors and LDCT image features]), and the American College of Radiology recommendations for lung nodules, version 1.1 (Lung-RADS).
Primary outcomes included model prediction performance, the absolute risk of a 1-year delay in cancer diagnosis, and the proportion of people without lung cancer assigned a biennial screening interval vs the proportion of cancer diagnoses delayed.
The study included 10 831 LDCT images from patients with presumed nonmalignant lung nodules (58.7% men; mean [SD] age, 61.9 [5.0] years), of whom 195 were diagnosed with lung cancer from the subsequent screen. The recalibrated LCP-CNN had substantially higher area under the curve (0.87) than LCRAT + CT (0.79) or Lung-RADS (0.69) to predict 1-year lung cancer risk (P < .001). If 66% of screens with nodules were assigned to biennial screening, the absolute risk of a 1-year delay in cancer diagnosis would have been lower for recalibrated LCP-CNN (0.28%) than LCRAT + CT (0.60%; P = .001) or Lung-RADS (0.97%; P < .001). To delay only 10% of cancer diagnoses at 1 year, more people would have been safely assigned biennial screening under LCP-CNN than LCRAT + CT (66.4% vs 40.3%; P < .001).
In this diagnostic study evaluating models of lung cancer risk, a recalibrated deep learning algorithm was most predictive of 1-year lung cancer risk and had least risk of 1-year delay in cancer diagnosis among people assigned biennial screening. Deep learning algorithms could prioritize people for workup of suspicious nodules and decrease screening intensity for people with low-risk nodules, which may be vital for implementation in health care systems.
每年进行低剂量计算机断层扫描(LDCT)筛查可降低肺癌死亡率,但通过重新使用 LDCT 图像结合深度学习或统计模型来识别低风险个体进行每两年一次的筛查,可降低危害并提高成本效益。
在国家肺癌筛查试验(NLST)中确定低危个体,并估计如果他们被分配进行每两年一次的筛查,将有多少肺癌病例会延迟 1 年诊断。
设计、地点和参与者:本诊断研究纳入了 2002 年 1 月 1 日至 2004 年 12 月 31 日期间 NLST 中疑似非恶性肺结节的参与者,随访于 2009 年 12 月 31 日完成。本研究的数据分析时间为 2019 年 9 月 11 日至 2022 年 3 月 15 日。
一种使用 LDCT 图像预测当前肺结节恶性程度的外部验证深度学习算法(肺癌预测卷积神经网络[LCP-CNN];Optellum Ltd)经过重新校准,以预测疑似非恶性结节的 LDCT 检测 1 年内的肺癌。根据重新校准的 LCP-CNN 模型、肺癌风险评估工具(LCRAT + CT[一种结合个体风险因素和 LDCT 图像特征的统计模型])和美国放射学院肺结节 1.1 版(Lung-RADS)建议,对疑似非恶性肺结节的个体进行年度或每两年一次的筛查。
主要结果包括模型预测性能、1 年内癌症诊断延迟的绝对风险,以及每两年分配一次筛查间隔的无肺癌人群比例与癌症诊断延迟比例。
该研究纳入了 10831 例疑似非恶性肺结节的 LDCT 图像(58.7%为男性;平均[标准差]年龄 61.9[5.0]岁),其中 195 例在随后的筛查中被诊断为肺癌。重新校准的 LCP-CNN 预测 1 年内肺癌风险的曲线下面积(AUC)显著高于 LCRAT + CT(0.79)或 Lung-RADS(0.69)(P<0.001)。如果 66%的肺结节筛查被分配到每两年一次的筛查,那么重新校准的 LCP-CNN 预测的 1 年内癌症诊断延迟的绝对风险将低于 LCRAT + CT(0.60%;P=0.001)或 Lung-RADS(0.97%;P<0.001)。为了仅延迟 10%的 1 年内癌症诊断,与 LCRAT + CT 相比,LCP-CNN 会将更多的人安全地分配到每两年一次的筛查中(66.4% vs 40.3%;P<0.001)。
在这项评估肺癌风险模型的诊断研究中,重新校准的深度学习算法对 1 年内肺癌风险的预测最准确,在被分配每两年一次筛查的人群中,1 年内癌症诊断延迟的风险最低。深度学习算法可以优先对可疑结节进行检查,并降低低风险结节的筛查强度,这对于在医疗保健系统中实施可能至关重要。