Project description:BACKGROUND:The aggressive and heterogeneous nature of lung cancer has thwarted efforts to reduce mortality from this cancer through the use of screening. The advent of low-dose helical computed tomography (CT) altered the landscape of lung-cancer screening, with studies indicating that low-dose CT detects many tumors at early stages. The National Lung Screening Trial (NLST) was conducted to determine whether screening with low-dose CT could reduce mortality from lung cancer. METHODS:From August 2002 through April 2004, we enrolled 53,454 persons at high risk for lung cancer at 33 U.S. medical centers. Participants were randomly assigned to undergo three annual screenings with either low-dose CT (26,722 participants) or single-view posteroanterior chest radiography (26,732). Data were collected on cases of lung cancer and deaths from lung cancer that occurred through December 31, 2009. RESULTS:The rate of adherence to screening was more than 90%. The rate of positive screening tests was 24.2% with low-dose CT and 6.9% with radiography over all three rounds. A total of 96.4% of the positive screening results in the low-dose CT group and 94.5% in the radiography group were false positive results. The incidence of lung cancer was 645 cases per 100,000 person-years (1060 cancers) in the low-dose CT group, as compared with 572 cases per 100,000 person-years (941 cancers) in the radiography group (rate ratio, 1.13; 95% confidence interval [CI], 1.03 to 1.23). There were 247 deaths from lung cancer per 100,000 person-years in the low-dose CT group and 309 deaths per 100,000 person-years in the radiography group, representing a relative reduction in mortality from lung cancer with low-dose CT screening of 20.0% (95% CI, 6.8 to 26.7; P=0.004). The rate of death from any cause was reduced in the low-dose CT group, as compared with the radiography group, by 6.7% (95% CI, 1.2 to 13.6; P=0.02). CONCLUSIONS:Screening with the use of low-dose CT reduces mortality from lung cancer. (Funded by the National Cancer Institute; National Lung Screening Trial ClinicalTrials.gov number, NCT00047385.).

Project description:BackgroundLung cancer is the largest contributor to mortality from cancer. The National Lung Screening Trial (NLST) showed that screening with low-dose helical computed tomography (CT) rather than with chest radiography reduced mortality from lung cancer. We describe the screening, diagnosis, and limited treatment results from the initial round of screening in the NLST to inform and improve lung-cancer-screening programs.MethodsAt 33 U.S. centers, from August 2002 through April 2004, we enrolled asymptomatic participants, 55 to 74 years of age, with a history of at least 30 pack-years of smoking. The participants were randomly assigned to undergo annual screening, with the use of either low-dose CT or chest radiography, for 3 years. Nodules or other suspicious findings were classified as positive results. This article reports findings from the initial screening examination.ResultsA total of 53,439 eligible participants were randomly assigned to a study group (26,715 to low-dose CT and 26,724 to chest radiography); 26,309 participants (98.5%) and 26,035 (97.4%), respectively, underwent screening. A total of 7191 participants (27.3%) in the low-dose CT group and 2387 (9.2%) in the radiography group had a positive screening result; in the respective groups, 6369 participants (90.4%) and 2176 (92.7%) had at least one follow-up diagnostic procedure, including imaging in 5717 (81.1%) and 2010 (85.6%) and surgery in 297 (4.2%) and 121 (5.2%). Lung cancer was diagnosed in 292 participants (1.1%) in the low-dose CT group versus 190 (0.7%) in the radiography group (stage 1 in 158 vs. 70 participants and stage IIB to IV in 120 vs. 112). Sensitivity and specificity were 93.8% and 73.4% for low-dose CT and 73.5% and 91.3% for chest radiography, respectively.ConclusionsThe NLST initial screening results are consistent with the existing literature on screening by means of low-dose CT and chest radiography, suggesting that a reduction in mortality from lung cancer is achievable at U.S. screening centers that have staff experienced in chest CT. (Funded by the National Cancer Institute; NLST ClinicalTrials.gov number, NCT00047385.).

Project description:BackgroundConventional CTCS images the mid/lower chest for coronary artery disease (CAD). Because many CAD patients are also at risk for lung malignancy, CTCS often discovers incidental pulmonary nodules (IPN). CTCS excludes the upper chest, where malignancy is common. Full-chest CTCS (FCT) may be a cost-effective screening tool for IPN.MethodsA decision tree was created to compare a FCT to CTCS in a hypothetical patient cohort with suspected CAD. (Figure) The design compares the effects of missed cancers on CTCS with the cost of working up non-malignant nodules on FCT. The model was informed by results of the National Lung Screening Trial and literature review, including the rate of malignancy among patients receiving CTCS and the rate of malignancy in upper vs lower portions of the lung. The analysis outcomes are Quality-Adjusted Life Year (QALY) and incremental cost-effectiveness ratio (ICER), which is generally considered beneficial when <$50,000/QALY.ResultsLiterature review suggests that rate of IPNs in the upper portion of the lung varied from 47 to 76%. Our model assumed that IPNs occur in upper and lower portions of the lung with equal frequency. The model also assumes an equal malignancy potential in upper lung IPNs despite data that malignancy occurs 61–66% in upper lung fields.In the base case analysis, a FCT will lead to an increase of 0.03 QALYs comparing to conventional CTCS (14.54 vs 14.51 QALY, respectively), which translates into an QALY increase of 16?days. The associated incremental cost for FCT is $278 ($1027 vs $748, FCT vs CTCS respectively. The incremental cost-effectiveness ratio (ICER) is $10,289/QALY, suggesting significant benefit. Sensitivity analysis shows this benefit increases proportional to the rate of malignancy in upper lung fields.ConclusionConventional CTCS may be a missed opportunity to screen for upper lung field cancers in high risk patients. The ICER of FCT is better than screening for breast cancer screening (mammograms $80?k/QALY) and colon cancer (colonoscopy $6?k/QALY). Prospective studies are appropriate to define protocols for FCT.

Project description:ImportanceAnnual 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.ObjectiveTo 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 participantsThis 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.ExposuresAn 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).Main outcomes and measuresPrimary 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.ResultsThe 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).Conclusions and relevanceIn 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.

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Reply to: Limitations of molecular testing in combination with computerized tomographic for lung cancer screening.

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