NCA - Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439R) - Decision Memo

RCT - randomized controlled trialCOSMOS - Continuous Observation of Smoking SubjectsDANTE - Detection And screening of early lung cancer with Novel imaging Technology and molecular assaysDLCST - Danish Lung Cancer Screening TrialITALUNG - Italian Lung Cancer Screening TrialLSS - Lung Screening StudyLUSI - Lung cancer Screening InterventionMILD - Multicentric Italian Lung DetectionNELSON - NederlandsLeuvens Longkanker Screenings OnderzoekNLST - National Lung Screening TrialUKLS - UK Lung Cancer Screening trialHR - hazard ratio, RR - rate ratio or risk ratio, OR - odds ratio, CI - confidence interval, SD  standard deviation, IQR - interquartile range, T0  baseline screening, yr(s)  year(s)Evidence-based GuidelinesUS Preventive Services Task Force, Krist AH, Davidson KW, Mangione CM, et al. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement.JAMA. 2021 Mar 9;325(10):962-970. doi: 10.1001/jama.2021.1117. PMID: 33687470Jonas DE, Reuland DS, Reddy SM, et al. Screening for Lung Cancer With Low-Dose Computed Tomography: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2021 Mar 9;325(10):971-987. doi: 10.1001/jama.2021.0377. PMID: 33687468Moyer VA; U.S. Preventive Services Task Force (USPSTF). Screening for lung cancer: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014 Mar 4;160(5):330-8. doi: 10.7326/M13-2771. PMID: 243789172021 USPSTF recommendation statement (USPSTF, Krist; 2021)The USPSTF recommends annual screening for lung cancer with LDCT in adults aged 50 to 80 years who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years. Screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery. (B recommendation) (USPSTF, Krist; 2021). This recommendation replaces the 2013 USPSTF statement that recommended annual screening for lung cancer with LDCT in adults aged 55 to 80 years who have a 30 pack-year smoking history and currently smoke or have quit within the past 15 years (USPSTF, Krist; 2021).The USPSTF concludes with moderate certainty that annual screening for lung cancer with LDCT has a moderate net benefit in persons at high risk of lung cancer based on age, total cumulative exposure to tobacco smoke, and years since quitting smoking. The moderate net benefit of screening depends on limiting screening to persons at high risk, the accuracy of image interpretation being similar to or better than that found in clinical trials, and the resolution of most false-positive results with serial imaging rather than invasive procedures. (USPSTF, Krist; 2021).2013 USPSTF recommendation statement (Moyer, USPSTF; 2014)In 2013, the US Preventive Services Task Force (USPSTF) recommended annual screening for lung cancer with low-dose computed tomography (LDCT) in adults aged 55 to 80 years who have a 30pack-year smoking history and currently smoke or have quit within the past 15 years (B recommendation). The USPSTF recommended that screening should be discontinued once a person has not smoked for 15 years or develops a health problem that substantially limits life expectancy or the ability or willingness to have curative lung surgery (Moyer, USPSTF; 2014).The USPSTF concludes with moderate certainty that annual screening for lung cancer with LDCT is of moderate net benefit in asymptomatic persons who are at high risk for lung cancer based on age, total cumulative exposure to tobacco smoke, and years since quitting smoking (Moyer, USPSTF; 2014).Donnelly EF, Kazerooni EA, Lee E, et al., and Expert Panel on Thoracic Imaging: ACR Appropriateness Criteria Lung Cancer Screening. J Am Coll Radiol. 2018 Nov;15(11S):S341-S346. doi: 10.1016/j.jacr.2018.09.025. PMID: 30392603In 2018, an expert panel on thoracic imaging assembled by the American College of Radiology reported that the American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment (Donnelly, 2018).In 2018, the American College of Radiology expert panel on thoracic imaging summarized their findings by reporting that for patients between the age of 55 and 80 with 30 or more pack-years smoking history who currently smoke or who have quit within the last 15 years should undergo lung cancer screening with low-dose CT. In patients who do not meet these criteria but who have additional risk factors for lung cancer, lung cancer screening with low-dose CT is controversial but may be appropriate. Imaging is not recommended for lung cancer screening of patient younger than 50 years of age or patients older than 80 years of age or patients of any age with less than 20 packs per year history of smoking and no additional risk factor (i.e., radon exposure, occupational exposure, cancer history, family history of lung cancer, history of [chronic obstructive pulmonary disease] (COPD), or history of pulmonary fibrosis (Donnelly, 2018).Radiation DosingAs a special imaging consideration, the American College of Radiology Appropriateness Criteria expert panel stated that in general, acceptable low-dose lung cancer screening CT scans should be performed according to the guidelines in the ACRSTR [American College of Radiology (ACR)-Society of Thoracic Radiology (STR)] Practice Parameter for the Performance and Reporting of Lung Cancer Screening Thoracic Computed Tomography (CT) (Donnelly, 2018). Additionally, because there is a wide range of radiation exposures associated with different diagnostic procedures, a relative radiation level (RRL) indication has been included for each imaging examination. The RRLs are based on effective dose, which is a radiation dose quantity that is used to estimate population total radiation risk associated with an imaging procedure (Donnelly, 2018).Mazzone PJ, Silvestri GA, Souter LH, et al. Screening for Lung Cancer: CHEST Guideline and Expert Panel Report  Executive Summary, CHEST (2021), doi: https://doi.org/10.1016/j.chest.2021.07.003.Mazzone PJ, Silvestri GA, Souter LH, et all. Screening for Lung Cancer: CHEST Guideline and Expert Panel Report, CHEST (2021), doi: https://doi.org/10.1016/j.chest.2021.06.063.The purpose of this guideline is to update the evidence base for the benefit, harms, and implementation of low-dose chest CT (LDCT) screening. The American College of Chest Physicians (CHEST)  used the updated evidence base to provide recommendations where the evidence allows, and statements based on experience and expert consensus where it does not. Approved panelists reviewed previously developed key questions using the PICO (population, intervention, comparator, and outcome) format to address the benefit and harms of low-dose CT screening, as well as key areas of program implementation. A systematic literature review was conducted using MEDLINE via PubMed, Embase, and the Cochrane Library on a quarterly basis since the time of the previous guideline publication. The systematic literature review identified 75 additional studies that informed the response to the 12 key questions that were developed. . . . Evidence suggests that low-dose CT screening for lung cancer can result in a favorable balance of benefit and harms. The selection of screen-eligible individuals, the quality of imaging and image interpretation, the management of screen detected findings, and the effectiveness of smoking cessation interventions, can impact this balance. (Mazzone, Executive Summary; 2021).RecommendationsThe panel drafted and graded recommendations based on the results of the meta-analyses and evidence profiles. Recommendations were graded according to CHESTs grading system which uses the GRADE approach. (Mazzone, Panel Report 2021). The recommendations were either strong or weak according to this approach. Strong recommendations use the wording we recommend and weak recommendations use the wording we suggest (Mazzone, Panel Report 2021).Excerpt from Recommendations (Mazzone, Panel Report 2021)1. For asymptomatic individuals age 55 to 77 who have smoked 30 pack-years or more and either continue to smoke or have quit within the past 1 years, we recommend that annual screening with low dose CT should be offered. (Strong recommendation, moderate quality evidence) 2. For asymptomatic individuals who do not meet the smoking and/or age criteria in Recommendation #1, are age 50-80, have smoked 20 pack-year or more and either continue to smoke or have quit within the past 15 years, we suggest that annual screening with low dose CT should be offered. (Weak recommendation, moderate quality evidence) 4. For individuals who have accumulated fewer than 20 pack-years of smoking or are younger than age 50 or older than 80, or have quit smoking more than 15 years ago, and are not projected to have a high net benefit from lung cancer screening based on clinical risk prediction or life-year gained calculators, we recommend that low dose CT screening should not be performed. (Strong recommendation, moderate quality evidence)NCCN (National Comprehensive Cancer Network). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Lung Cancer Screening, Version 1.2021  December 17, 2020. https://www.nccn.org/professionals/physician_gls/pdf/lung_screening.pdf. Accessed 6/17/2021.In the National Comprehensive Cancer Network (NCCN), Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Lung Cancer Screening Version 1.2021, the NCCN Lung Cancer Screening Panel defined the risk status of high risk as age  50 years and  20 pack-year history of smoking with these high-risk persons candidates for low dose CT (LDCT) screening (category 1) where shared patient/physician decision-making is recommended, including a discussion of benefits/risks (NCCN, 2020). For NCCN categories of evidence and consensus, Category 1 is defined as based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate (NCCN, 2020). The updates in the clinical pathway algorithms in the current Version 1.2021 (NCCN, 2020) of the NCCN Guidelines for Lung Cancer Screening from Version 1.2020 include high risk status being modified with the age range from 55 to 77 years to  50 years and from  30 to  20 pack-year history of smoking (NCCN, 2020).Radiation DoseThe guidelines report that all screening and follow-up chest CT scans should be performed at low-dose (100-120 kVp [kilovoltage peak] and 40-60 mAs [milliampere-seconds] or less), unless evaluating mediastinal abnormalities or lymph nodes, where standard-dose CT with IV [intravenous] contrast might be appropriate (NCCN, 2020).