Current Lung Cancer Screening Guidelines Research Articles

Acceptability of Personalized Lung Cancer Screening Program Among Primary Care Providers.

Personalized LCS facilitated by a risk model and/or a biomarker test is proposed as an alternative to existing programs. Acceptability of personalized approach among PCPs is unknown. The goal of this study is to assess the acceptability of personalized LCS among PCPs.

Lung cancer screening status and acceptability of a personalized approach in Texas.

e22516 Background: Current lung cancer screening (LCS) guidelines rely on age and smoking history. Despite its proven benefit, only 5-15% of eligible patients receive LCS, with Texas having one of the lowest rates among states in the US. Personalized screening strategies select people for LCS based on their personal lung cancer risk and may increase LCS’s effectiveness and efficiency. We assess current LCS practices and the acceptability of personalized LCS among primary care providers (PCP) in Texas. Methods: We surveyed 32,983 Texas-based PCPs including primary care physicians, physician assistants, and nurse practitioners on an existing network (Protocol 2019-1257; PI: Dr. Shete), and 400 attendees of the 2022 Texas Academy of Family Physicians (TAFP) conference. Deidentified demographics, current LCS practices, and acceptability of personalized LCS were obtained. We analyzed the responses by subgroups of interest using comparative statistics. Using nonparametric bootstrap, we derived an enriched dataset and utilized it to develop logistic regression models to further understand respondent tendencies related to current LCS practices and acceptability of personalized LCS. Results: Response rates were 0.3% (n=91) and 15% (n=60) for the 2019-1257 and TAFP surveys, respectively. Respondent demographics are provided in the table. Most (84%) respondents regularly assess LCS in their practice, with those in the following categories more likely to assess for LCS eligibility: 40-49 years old, female, non-Black, physicians, with <10 years in practice, seeing >50 patients per week, and work at a non-residency training site (all p-values < 0.05). Half of the respondents were interested in adopting personalized LCS while an additional 40% wanted to learn more information. Respondents in the following categories were associated with increased interest in personalized LCS: younger than 60 years, non-White, non-physicians, seeing 100 or more patients per week, at a non-residency training site, and at a decentralized practice (all p values < 0.05). Majority (66%) of respondents expressed concerns regarding time availability with the personalized LCS. Conclusions: There is a great need to enhance the awareness and engagement of Texas-based PCPs about LCS. Most of the respondents expressed interest in personalized LCS. Time availability was the main concern related to personalized LCS. Findings from this project highlight the need for better education of Texas-based PCPs on the benefits of LCS, and the development of efficient decision tools to facilitate shared decision-making sessions to ensure successful implementation of personalized LCS. [Table: see text]

Idiopathic pulmonary fibrosis and lung cancer: future directions and challenges.

Idiopathic pulmonary fibrosis (IPF) is a progressive disease of pulmonary scarring. New treatments slow disease progression and allow pulmonary fibrosis patients to live longer. Persistent pulmonary fibrosis increases a patient's risk of developing lung cancer. Lung cancer in patients with IPF differs from cancers that develop in the non-fibrotic lung. Peripherally located adenocarcinoma is the most frequent cell type in smokers who develop lung cancer, while squamous cell carcinoma is the most frequent in pulmonary fibrosis. Increased fibroblast foci in IPF are associated with more aggressive cancer behaviour and shorter doubling times. Treatment of lung cancer in fibrosis is challenging because of the risk of inducing an exacerbation of fibrosis. In order to improve patient outcomes, modifications of current lung cancer screening guidelines in patients with pulmonary fibrosis will be necessary to avoid delays in treatment. 2-fluoro-2-deoxy-d-glucose (FDG) positron emission tomography (PET) computed tomography (CT) imaging can help identify cancer earlier and more reliably than CT alone. Increased use of wedge resections, proton therapy and immunotherapy may increase survival by decreasing the risk of exacerbation, but further research will be necessary.

Circulating nucleosomes to identify non-smoker subjects at risk of lung cancer and triage them for low-dose CT scan.

e20558 Background: Lung cancer (LC) is the leading cause of cancer death worldwide and the most frequently occurring in men and the second most diagnosed cancer in woman after breast cancer. The primary risk factor leading to LC is tobacco smoke. Nevertheless, several studies in the US, UK and Asia reported an increasing rate of LC in non-smokers. 15-20% of LC patients worldwide are non-smokers with this percentage rising to 60% in non-smoking women in Asia. Current LC screening guidelines recommend a CT scan only for high-risk smokers. Despite there being no guidelines to recommend LC screening in non-smokers those with increased risk factors could be monitored. Therefore, a blood-test could offer a simple way to identify non-smokers at high-risk of LC and triage them to go for low-dose CT scan. Methods: We measured circulating levels of nucleosomes and CEA in 722 non-smoker subjects referred for CT scan at National Taiwan University Hospital. The patients were later confirmed to have either a LC (n = 509, including 401 patients at stage 0-1), non-malignant nodules (n = 142), or no-nodules (n = 71). Whole blood was collected in EDTA plasma tubes for analysis by six different Nu.Q chemiluminescent magnetic microparticle immunoassays (Belgian Volition SRL, Belgium) targeting H3.1-nucleosomes or different histone modifications (H3K9Me3-, H3K27Me3-, H3K36Me3-, H3K9Ac-, H3K14Ac-nucleosomes). CEA was analyzed on the Abbott ARCHITECT analyzer. We defined by logistic regression the best combination of biomarkers to identify LC cases in this non-smoking population in a rule-in approach. Results: At 95% specificity, none of the individual biomarkers exceed 24.8% of sensitivity for LC vs non-malignant nodules and no nodules. A combination of 2 nucleosome biomarkers: H3K9Me3- and H3K9Ac-nucleosomes with CEA in a logistic regression model showed improved sensitivity detecting 32.4% of LC in the non-smoker subjects at 95% specificity for LC vs non-malignant nodules and no nodules (area under the curve (AUC): 0.76, R2: 19.1%). In a non-smoking women sub-group by adding a third nucleosome biomarker: H3K36Me3-nucleosomes to the model we could detect 34.3% of the women who have lung cancer at 95% specificity (AUC: 0.75; R2: 20.2%). Conclusions: Our results indicate that a blood test combining circulating nucleosomes targeting different epigenetic modifications with CEA allow the detection of LC cases in a non-smokers population. This blood test could be part of the screening criteria for the non-smoking population at risk to develop LC and could help to triage them for low-dose CT scan.

P10.08 Comparing Lung Cancer in Never Smokers and Ever Smokers in Asian or Asian American Patients Treated at a Tertiary Urban Public Hospital in New York

The higher incidence of targetable mutations in Asian patients with lung cancer clearly suggests potentially different risk factors and underlying biology. Most of the studies regarding lung cancer in Asian patients were conducted in Asia, but limited data is known about Asian or Asian American patients in the U.S. While current lung cancer screening guidelines only affect smoker populations, expanding screening to other high risk populations is of interest. The purpose of this study is to assess various characteristics of Asian or Asian American lung cancer patients at a public hospital in New York.

Current lung cancer screening guidelines may miss high-risk population: a real-world study

BackgroundDespite much research published on lung cancer screening, China has had no large-scale study on the missed diagnosis of lung cancer in a health examination population. We therefore did a real-world study using the current lung cancer screening guidelines to a health examination population in China to determine the proportion of lung cancer cases that have been missed.MethodsA real-world cohort study of screening, with the use of low-dose computed tomography, was conducted among people who took yearly health checkup in health management center of West China Hospital between 2006 and 2017. We respectively used current guidelines including lung cancer screening guidelines of the U.S. Preventive Services Task Force (USPSTF) and expert consensus on low dose spiral CT lung cancer screening in China.ResultsIn a total of 15,996 participants with health examination who completed the baseline screening, 6779 (42.4%) subjects had at least one positive finding, and 142 (2.1%) cases of lung cancer were screened positive. The false positive rate was 97.9%. Of 142 lung cancer cases detected in our study, only 9.2% met the lung cancer screening guidelines proposed by the USPSTF, and 24.4% met that of China. The rates of missed diagnosis were as high as 90.8 and 75.6% respectively. In addition, we did an in-depth analysis by gender. We found that among male patients with lung cancer, the proportion of smokers was 75%, and the proportion of young people under 50 was 23.2%. Among female patients with lung cancer, the proportion of smokers was only 5.8%, and the proportion of young people under 50 was up to 33.3%.ConclusionsThe rate of missed diagnosis was as high as 90.8% applying the current lung cancer screening guidelines to the health examination population in China. Further study to determine screening guidelines for targeted populations, is warranted.

Management of Pulmonary Nodules in Oncologic Patients: AJR Expert Panel Narrative Review.

Cancer survivors are at higher risk than the general population for development of a new primary malignancy, most commonly lung cancer. Current lung cancer screening guidelines recommend low-dose chest CT for high-risk individuals, including patients with a history of cancer and a qualifying smoking history. However, major lung cancer screening trials have inconsistently included cancer survivors, and few studies have assessed management of lung nodules in this population. This narrative review highlights relevant literature and provides expert opinion for management of pulmonary nodules detected incidentally or by screening in oncologic patients. In patients with previously treated lung cancer, a new nodule most likely represents distant metastasis from the initial lung cancer or a second primary lung cancer; CT features such as nodule size and composition should guide decisions regarding biopsy, PET/CT, and CT surveillance. In patients with extrapulmonary cancers, nodule management requires individualized risk assessment; smoking is associated with increased odds of primary lung cancer, whereas specific primary cancer types are associated with increased odds of pulmonary metastasis. Nonneoplastic causes, such as infection, medication toxicity, and postradiation or postsurgical change, should also be considered. Future prospective studies are warranted to provide evidence-based data to assist clinical decision-making in this context.

IMPROVING RATE OF LUNG CANCER SCREENING IN PRIMARY CARE CLINIC

SESSION TITLE: Lung Cancer Posters SESSION TYPE: Original Investigation Posters PRESENTED ON: October 18-21, 2020 PURPOSE: The National Lung Cancer Screening Trial showed reduced lung cancer mortality with low-dose computed tomography (LDCT) screening. Although LDCT is generally covered by private and government insurance, the rate of LDCT screening is reported to be about 2-3% in previous studies. One of the main barrier in adequate screening was assessment of smoking history to identify eligible populations. Our study aims to address this barrier and improve the rate of lung cancer screening in Medstar Washington Hospital Center Internal Medicine (WHCIM) clinics. We aim to achieve an improvement from a baseline rate of 2.88% by 50% over a 3-month period. METHODS: Data from cumulative patient visits at WHCIM clinic was collected over a 2 week period to assess the baseline rate of LDCT screening. After multidisciplinary team meeting to assess the barriers in adequate screening, we piloted a clinical reminder in the form of print-out form given to physicians from the medical assistants. This served to remind physicians to take detailed smoking histories and included the current lung cancer screening guidelines. This reminder is being given to providers for each patient seen in the clinic and the results will be followed for the next 3 months. For this study post-intervention data was collected over a 2 week period. RESULTS: Preceding the intervention, providers documented a smoking history in 16% of patients seen where post-intervention was 26%. Prior to the clinical reminder 2.88% of all patients seen over the age of 55 were referred for lung cancer screening which has now increased to 6.0%. Of patients who met the criteria for lung cancer screening, prior to the intervention only 42% of patients were referred for LDCT. However, after the clinical reminder has been initiated, 86% of patients who did meet the criteria were sent for screening. CONCLUSIONS: Our intervention has increased documentation of smoking history by 62% and lung cancer screening, for those who meet the criteria according to the guidelines, by a relative increase of 105%. We are currently working on further interventions to incorporate this clinical reminder into the electronic medical record and to implement this across the Medstar Health Hospitals. CLINICAL IMPLICATIONS: Lung cancer is the leading cause of death not only in the United States, but throughout the world. Improving the rate of lung cancer screening by addressing barriers is a simple and cost-effective method that would go a long way in lowering lung cancer mortality. Furthermore, multidisciplinary team involvement helps address gaps in patient care in a holistic manner. DISCLOSURES: No relevant relationships by Anika Bhargava, source=Web Response No relevant relationships by Akshay Kohli, source=Web Response no disclosure on file for Irina Veytsman

Understanding barriers to lung cancer screening in primary care.

BackgroundLow-dose computed tomography (LDCT) scan for lung cancer screening is underutilized. Studies suggest that up to one-third of providers do not know the current lung cancer screening guidelines. Thus, identifying the barriers to utilization of LDCT scan is essential.MethodsPrimary care providers in three different healthcare settings in the United States were surveyed to assess provider knowledge of LDCT scan screening criteria, lung cancer screening practices, and barriers to the utilization of LDCT scan screening. Fisher’s Exact, Chi-Squared, and Kruskal-Wallis tests were used to compare provider responses. Multivariable logistic regression was used to test the association between provider characteristics and the likelihood of utilizing LDCT scan for lung cancer screening.ResultsThe survey was sent to 614 providers, with a 15.7% response rate. Overall, 29.2% of providers report never ordering LDCT scans for eligible patients. Providers practicing at a community or academic hospital more frequently order LDCT scans than those practicing at a safety net hospital. Academic- and community-based providers received a significantly higher mean knowledge score than safety net-based providers [academic 6.84 (SD 1.33), community 6.72 (SD 1.46), safety net 5.85 (SD 1.38); P<0.01]. Overall, only 6.2% of respondents correctly identified all six Centers for Medicare and Medicaid Services eligibility criteria when challenged with three incorrect criteria. Common barriers to utilization of LDCT scan included failure of the electronic medical record (EMR) to notify providers of eligible patients (54.7%), patient refusal (37%), perceived high false-positive rate leading to unnecessary procedures (18.9%), provider time constraints (16.8%), and lack of insurance coverage (13.7%).ConclusionsProvider knowledge of lung cancer screening guidelines varies, perhaps contributing to underutilization of LDCT scan for lung cancer screening. Improved provider education at safety net hospitals and improving EMR-based best practice alerts may improve the rate of lung cancer screening.

Prediction of lung cancer risk at follow-up screening with low-dose CT: a training and validation study of a deep learning method

Current lung cancer screening guidelines use mean diameter, volume or density of the largest lung nodule in the prior computed tomography (CT) or appearance of new nodule to determine the timing of the next CT. We aimed at developing a more accurate screening protocol by estimating the 3-year lung cancer risk after two screening CTs using deep machine learning (ML) of radiologist CT reading and other universally available clinical information. A deep machine learning (ML) algorithm was developed from 25,097 participants who had received at least two CT screenings up to two years apart in the National Lung Screening Trial. Double-blinded validation was performed using 2,294 participants from the Pan-Canadian Early Detection of Lung Cancer Study (PanCan). Performance of ML score to inform lung cancer incidence was compared with Lung-RADS and volume doubling time using time-dependent ROC analysis. Exploratory analysis was performed to identify individuals with aggressive cancers and higher mortality rates. In the PanCan validation cohort, ML showed excellent discrimination with a 1-, 2- and 3-year time-dependent AUC values for cancer diagnosis of 0·968±0·013, 0·946±0·013 and 0·899±0·017. Although high ML score cohort included only 10% of the PanCan sample, it identified 94%, 85%, and 71% of incident and interval lung cancers diagnosed within 1, 2, and 3 years, respectively, after the second screening CT. Furthermore, individuals with high ML score had significantly higher mortality rates (HR=16·07, p<0·001) compared to those with lower risk. ML tool that recognizes patterns in both temporal and spatial changes as well as synergy among changes in nodule and non-nodule features may be used to accurately guide clinical management after the next scheduled repeat screening CT.

Evaluation of USPSTF Lung Cancer Screening Guidelines Among African American Adult Smokers

The United States Preventive Services Task Force (USPSTF) recommends low-dose computed tomography screening for lung cancer. However, USPSTF screening guidelines were derived from a study population including only 4% African American smokers, and racial differences in smoking patterns were not considered. To evaluate the diagnostic accuracy of USPSTF lung cancer screening eligibility criteria in a predominantly African American and low-income cohort. The Southern Community Cohort Study prospectively enrolled adults visiting community health centers across 12 southern US states from March 25, 2002, through September 24, 2009, and followed up for cancer incidence through December 31, 2014. Participants included African American and white current and former smokers aged 40 through 79 years. Statistical analysis was performed from May 11, 2016, to December 6, 2018. Self-reported race, age, and smoking history. Cumulative exposure smoking histories encompassed most recent follow-up questionnaires. Incident lung cancer cases assessed for eligibility for lung cancer screening using USPSTF criteria. Among 48 364 ever smokers, 32 463 (67%) were African American and 15 901 (33%) were white, with 1269 incident lung cancers identified. Among all 48 364 Southern Community Cohort Study participants, 5654 of 32 463 African American smokers (17%) were eligible for USPSTF screening compared with 4992 of 15 901 white smokers (31%) (P < .001). Among persons diagnosed with lung cancer, a significantly lower percentage of African American smokers (255 of 791; 32%) was eligible for screening compared with white smokers (270 of 478; 56%) (P < .001). The lower percentage of eligible lung cancer cases in African American smokers was primarily associated with fewer smoking pack-years among African American vs white smokers (median pack-years: 25.8 [interquartile range, 16.9-42.0] vs 48.0 [interquartile range, 30.2-70.5]; P < .001). Racial disparity was observed in the sensitivity and specificity of USPSTF guidelines between African American and white smokers for all ages. Lowering the smoking pack-year eligibility criteria to a minimum 20-pack-year history was associated with an increased percentage of screening eligibility of African American smokers and with equitable performance of sensitivity and specificity compared with white smokers across all ages (for a 55-year-old current African American smoker, sensitivity increased from 32.2% to 49.0% vs 56.5% for a 55-year-old white current smoker; specificity decreased from 83.0% to 71.6% vs 69.4%; P < .001). Current USPSTF lung cancer screening guidelines may be too conservative for African American smokers. The findings suggest that race-specific adjustment of pack-year criteria in lung cancer screening guidelines would result in more equitable screening for African American smokers at high risk for lung cancer.

Lifetime Smoking History and Risk of Lung Cancer: Results From the Framingham Heart Study.

The relative risk of lung cancer decreases with years since quitting (YSQ) smoking, but risk beyond 25 YSQ remains unclear. Current lung cancer screening guidelines, which exclude smokers with more than 15 YSQ, may not detect lung cancers in this population. We analyzed data from Framingham Heart Study Original (n = 3905) and Offspring cohort (n = 5002) participants for lifetime smoking and lung cancer incidence from 1954 to 1958 (Exam 4) and 1971 to 1975 (Exam 1), respectively, through 2013. We used multivariable-adjusted Cox proportional hazards regression models to compare current, former, and never smokers and lung cancer risk. Smoking status and covariates were time-updated every two years (Original) or four years (Offspring). Primary analyses were restricted to heavy ever smokers with more than 21.3 pack-years; additional analyses included all ever smokers. On follow-up (median = 28.7 years), 284 lung cancers were detected: incidence rates/1000 person-years in current, former, and never smokers were 1.97 (95% confidence interval [CI] = 1.66 to 2.33), 1.61 (95% CI = 1.34 to 1.93), and 0.26 (95% CI = 0.17 to 0.39), respectively. Heavy former (vs never) smokers had elevated lung cancer risk at all YSQ (<5: hazard ratio [HR] = 12.12, 95% CI = 6.94 to 21.17; 5-9: HR = 11.77, 95% CI = 6.78 to 20.45; 10-14: HR = 7.81, 95% CI = 3.98 to 15.33; 15-24: HR = 5.88, 95% CI = 3.19-10.83; ≥25: HR = 3.85, 95% CI = 1.80 to 8.26). Heavy former (vs current) smokers had 39.1% lower lung cancer risk within five YSQ. Among all former smokers, 40.8% of lung cancers occurred after more than 15 YSQ. Among heavy former smokers, lung cancer risk drops within five YSQ relative to continuing smokers, yet it remains more than threefold higher than never smokers after 25 YSQ. Four of ten lung cancers occurred in former smokers with more 15 YSQ, beyond the screening window of the current guideline.

Systematic Review of the Methodology Quality in Lung Cancer Screening Guidelines

背景与目的早期筛查可降低肺癌的死亡率，依据高质量的筛查指南进行实践工作是十分重要和必要的。本研究旨在了解国内外肺癌筛查指南研究的方法学质量，为我国的肺癌筛查权威指南的制定工作提供借鉴。方法检索PubMed、Embase、Cochrane图书馆（Cochrane Library, CL）、Web of Science数据库、中国期刊全文数据库（China National Knowledge Infrastructure, CNKI）、中国生物医学文献数据库（China Bio-Medicine database, CBM）和万方等中英文共7个数据库（截至2016年2月）和相关网站有关肺癌筛查指南的所有中英文文献，按既定的纳入与排除标准，筛选文献、纳入国内外公开发布的国内外独立报告的具备方法学描述的肺癌筛查指南，采用欧洲指南研究与评估工具（Appraisal of Guidelines Research and Evaluation in Europe, AGREE Ⅱ）对质量进行评价。结果① 共纳入11篇报告研究方法的肺癌筛查指南。②纳入指南主要由美国（81%）发布，中国和加拿大各发布1篇具备方法学描述的指南。③政府发布指南1篇，肿瘤/胸科等专业机构发布指南数9篇，未指明发布机构的指南1篇。④方法学质量评估结果：“范围和目的”领域总体评价结果平均80分，“参与人员”领域总体评价结果平均52分，“严谨性”领域总体评价结果平均50分，“清晰性”领域总体评价结果平均76分，“应用性”领域总体评价结果平均43分和“独立性”领域总体评价结果平均59分。2013年和2015年发布的指南在各领域评分较高。加拿大的指南在6个领域得分均最高。7篇指南为A推荐等级，其余4篇指南为B推荐等级。结论① 指南发布数量呈上升趋势，主要集中在肺癌疾病负担较重的国家。②指南的制定或更新有不断打破国家和地区界限的趋势。③循证实践指南制定方法已经逐渐成为各国研究制定临床指南的趋势。④我国发布了1篇原创和独立呈现的肺癌筛查指南，质量较好。

Do Current Lung Cancer Screening Guidelines Apply for Populations With High Prevalence of Granulomatous Disease? Results From the First Brazilian Lung Cancer Screening Trial (BRELT1)

Low-dose computed tomography (LDCT) screening for lung cancer has been demonstrated to be effective in reducing cancer mortality. However, these studies have not been undertaken in countries where the incidence of granulomatous disease is high. The First Brazilian Lung Cancer Screening Trial (BRELT1) has completed initial accrual and is now in the follow-up phase. We present results from the initial prevalence round of screening. The inclusion criteria were the same as those for the National Lung Cancer Screening Trial (NLST). Pulmonary nodules larger than 4 mm were considered positive and required evaluation by a multidisciplinary team. Indeterminate nodules were evaluated with fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) or biopsy when indicated. Statistical analysis was performed with Fisher's exact test to compare our positive findings with those of the NLST. From January 2013 to July 2014, 790 participants were enrolled. Positive LDCT scans were reported in 312 (39.4%) participants, with a total of 552 nodules larger than 4 mm. The comparison between positive findings in the NLST (7,191 of 26,722 cases) and those in the BRELT1 (312 of 790 cases) showed a significant difference (p < 0.001). The positive predictive value was lower in BRELT1 than in the NLST (3.2% versus 3.8%, respectively). Follow-up imaging was indicated in 278 of 312 (89.1%) participants; 35 procedures were performed in 25 participants. In 15 cases, benign lesions were diagnosed. Non-small-cell lung cancer (NSCLC) was diagnosed in 10 patients (prevalence of 1.3%). In 8 patients (stage IA/IB disease), treatment was by resection only, in 1 patient neoadjuvant chemotherapy was used (stage IIIA), and in 1 patient advanced disease was diagnosed (stage IV). Using NSLT criteria, a larger number of patients had positive scans (nodules), compared with previous lung cancer screening studies. However, the number of participants requiring surgical biopsy procedures and who were ultimately identified as having cancer was similar to other reports. This supports the role of screening in patient populations with a high incidence of granulomatous inflammation.

Current Lung Cancer Screening Guidelines May Exclude High Risk Populations

Current Lung Cancer Screening Guidelines May Exclude High Risk Populations

Use of Epidermal Growth Factor Receptor Mutation Analysis in Patients with Advanced Non-Small-Cell Lung Cancer to Determine Erlotinib Use as First-Line Therapy

Lung cancer is the second most common cancer and the leading cause of cancer-related deaths in the United States. Moreover, advanced non-small-cell lung cancer (NSCLC) is considered an incurable disease and current treatment approaches provide marginal improvement in overall survival at the expense of substantial morbidity and mortality, highlighting the need for new, less toxic treatment approaches. Tyrosine kinase inhibitors, such as erlotinib (Tarceva®), have been developed and approved as maintenance, second- and third-line treatment options in unselected advanced NSCLC patients (2, 15). However, subgroup analyses from the initial clinical trials consistently showed that patients with epidermal growth factor receptor (EGFR) mutations who received erlotinib had higher rates of response and better progression-free and overall survival, leading to clinical trials specifically focused on the use of tyrosine kinase inhibitors as first-line therapy in these patients. We examined the published literature on the analytic validity, clinical validity, and clinical utility of EGFR mutational testing in guiding first-line therapy use of erlotinib to treat advanced NSCLC and we briefly summarized the current lung cancer screening guidelines. The primary goal was to provide a basic overview of EGFR mutational testing and use of erlotinib as first-line therapy and identify gaps in knowledge and evidence that affect the recommendation and adoption of the test in advanced NSCLC treatment management strategies.