Annual Lung Cancer Screening Research Articles

P2.16G.01 Annual Lung Cancer Screening Day in the United States- Year Two

P2.16G.01 Annual Lung Cancer Screening Day in the United States- Year Two

Cost-effectiveness of lung cancer screening with volume computed tomography in Portugal.

Aim: Lung cancer is the most common cause of cancer death in Portugal. The Dutch-Belgian lung cancer screening (LCS) study (NELSON), the biggest European LCS study, showed a lung cancer mortality reduction in a high-risk population when being screened. In this study, the cost-effectiveness of LCS, based on the NELSON study protocol and outcomes, was evaluated compared with no screening in Portugal. Methods: The present study modified an established decision tree by incorporating a state-transition Markov model to evaluate the health-related advantages and economic implications of low-dose computed tomography (LDCT) LCS from the healthcare standpoint in Portugal. The analysis compared screening versus no screening for a high-risk population aged 50-75 with a smoking history. Various metrics, including clinical outcomes, costs, quality-adjusted life years (QALYs), life-years (LYs) and the incremental cost-effectiveness ratio (ICER), were calculated to measure the impact of LDCT LCS. Furthermore, scenario and sensitivity analyses were executed to assess the robustness of the obtained results. Results: Annual LCS with volume-based LDCT resulted in €558million additional costs and 86,678 additional QALYs resulting in an ICER of €6440 per QALY for one screening group and a lifetime horizon. In total, 13,217 premature lung cancer deaths could be averted, leading to 1.41 additional QALYs gained per individual diagnosed with lung cancer. Results are robust based on the sensitivity analyses. Conclusion: This study showed that annual LDCT LCS for a high-risk population could be cost-effective in Portugal based on a willingness to pay a threshold of one-time the GDP (€19,290 per QALY gained).

Abstract A139: Patient and provider barriers and facilitators to lung cancer screening: I-STEP 2 Study

Abstract Purpose: While lung cancer is a leading cause of death in the U.S., annual lung cancer screening (LCS) rates remain low. After deployment of an implementation intervention to increase lung cancer screening (LCS) and referral, we used a qualitative approach to identify barriers and facilitators, and recommended supports to increase screening. Methods: Semi-structured interviews were conducted with patients (n=66) and providers (n=59) across 15 BJC Consortium hospitals. Interview domains included perceptions and experiences with LCS referral and completion, barriers and facilitators to LCS, and the impact of the COVID-19 pandemic on these processes. Patients were eligible if they had been referred for LCS. Providers were eligible if they were involved in the LCS decision-making and referral process. Interviews were audio-recorded, de-identified, and transcribed. Deductive and inductive codes were developed separately for patients and providers. Coded data were analyzed to determine themes. Results: Patients cited transportation, uncertainty surrounding insurance coverage for screening, and the COVID-19 pandemic as barriers to accessing LCS. Due to the Medicare and Medicaid requirement of a documented shared decision-making visit prior to providing an LCS referral, providers cited time constraints during patient encounters as a barrier to delivering optimal LCS care. Both patients and providers reported low general awareness of LCS (compared to other preventive screening services) as a barrier to utilization. Patients described many facilitators to LCS including fears regarding cancer risk, knowledge of the benefits of early cancer detection in improving cancer outcomes, provider recommendations, ease of LCS process, and receiving educational materials about LCS. Providers also describe access to evidence-based outreach and education materials regarding LCS, and implementation of clinical decision support tools (e.g. pre-screening for LCS eligibility and insurance authorization, integration of EMR prompts centered around LCS and nodule surveillance) as facilitators for screening. Patients and providers highlighted the importance of LCS navigators in facilitating communication and reducing barriers to LCS and surveillance – specifically, patients found one-on-one support and education with navigators to be encouraging as they underwent LCS. Conclusion: While there are some key barriers related to lung cancer screening and follow-up, there are many facilitators to screening that can be leveraged to increase referrals and enable successful follow-up management after screening. Recommended additions to basic lung screening intervention materials include provider education on how lung cancer screening referral processes are unique in comparison to other screenings, how providers can foster patient understanding of lung nodules, and local support and resources to help patients navigate barriers to lung screening. Citation Format: Amy Ayala, Meera Muthukrishnan, Sydney Beache, Michelle Silver, Courtney Harriss, Graham Colditz, Aimee James. Patient and provider barriers and facilitators to lung cancer screening: I-STEP 2 Study [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A139.

Lung Cancer Screening in the US, 2022

The US Preventive Services Task Force (USPSTF) recommends annual lung cancer screening (LCS) with low-dose computed tomography in high-risk individuals (age 50-80 years, ≥20 pack-years currently smoking or formerly smoked, and quit <15 years ago) for early detection of LC. However, representative state-level LCS data are unavailable nationwide. To estimate the contemporary prevalence of up-to-date (UTD) LCS in the US nationwide and across the 50 states and the District of Columbia. This cross-sectional study used data from the 2022 Behavioral Risk Factor Surveillance System (BRFSS) population-based, nationwide, state-representative survey for respondents aged 50 to 79 years who were eligible for LCS according to the 2021 USPSTF eligibility criteria. Data analysis was performed from October 1, 2023, to March 20, 2024. The main outcome was self-reported UTD-LCS (defined as past-year) prevalence according to the 2021 USPSTF eligibility criteria in respondents aged 50 to 79 years. Adjusted prevalence ratios (APRs) and 95% CIs compared differences. Among 25 958 sample respondents eligible for LCS (median [IQR] age, 62 [11] years), 61.5% reported currently smoking, 54.4% were male, 64.4% were aged 60 years or older, and 53.0% had a high school education or less. The UTD-LCS prevalence was 18.1% overall, but varied across states (range, 9.7%-31.0%), with relatively lower levels in southern states characterized by high LC mortality burden. The UTD-LCS prevalence increased with age (50-54 years: 6.7%; 70-79 years: 27.1%) and number of comorbidities (≥3: 24.6%; none: 8.7%). A total of 3.7% of those without insurance and 5.1% of those without a usual source of care were UTD with LCS, but state-level Medicaid expansions (APR, 2.68; 95% CI, 1.30-5.53) and higher screening capacity levels (high vs low: APR, 1.93; 95% CI, 1.36-2.75) were associated with higher UTD-LCS prevalence. This study of data from the 2022 BRFSS found that the overall prevalence of UTD-LCS was low. Disparities were largest according to health care access and geographically across US states, with low prevalence in southern states with high LC burden. The findings suggest that state-based initiatives to expand access to health care and screening facilities may be associated with improved LCS rates and reduced disparities.

A variety of inflammatory shadows caused by COVID-19 on chest CT that closely resembled lung cancer in annual lung cancer screening.

e23122 Background: Chest X ray (CXR) has been the most common screen test procedure for detection of lung cancer. Before COVID-19, we have shown that repeat visitors (R) had a significantly lower proportion of CXR abnormalities requiring medication than the first-time visitors (F) at annual lung cancer screening. (Kimura T. Health Prim Car, 2021). During COVID-19, we reported that the influence of large waves of COVID-19 in annual lung cancer screening. (Kimura T. abstract No. e18596, ASCO annual meeting 2023) Because of the widespread use of vaccines, the XBB variants, derived from Omicron BA.2, has mainly cold-like symptoms. These variants spreads more easily than the original or the Delta variants. In Japan, since May 2023, COVID-19 has been made less dangerous under the Infectious Disease Control Law, which loosens the restrictions on wearing masks and having close contacts. No longer visits the hospital unless there is a high fever or dyspnea. Hypothesis is that there is a difference in lung cancer screening after a COVID-19 infestation compared to during and before COVID-19. Methods: Our clinic “MedCity21” is a university outpatient clinic for medical check-ups as a part of private health screening programs. Our facility allows COVID-19 diagnosed participants (pts) 5 days after onset or 24 hours after symptoms have abated. When the abnormalities were detected on CXR, pts were notified in a week by telephone request and invited to our specialty clinic for chest CT scan as further examination. By year from 2018 to 2023, we examined the varieties of abnormal shadows on CXR and CT and compared the differences using the chi-squared tests. Results: In 2023, there were 15072pts were visited our clinic for private health screening, among them, 13451pts (F:23.8%, R:75.2%) had chest X-rays performed. The January 2022, percentage of pts with a history of COVID was 1.68%, gradually increased, reaching 46.6% in December 2023. There were 226pts (1.68%) with CXR abnormalities requiring further investigation. The rates in F and R were 3.06% and 1.23%, respectively. The distributions of CXR and CT variations on R group were consistent with our previous report. However, significantly increased rate of inflammatory changes in CT findings (16.3%) in F group compared to each previous year (3.2-6.9%). (p = 0.014) We experienced a variety of inflammatory shadows on chest CT that closely resembled lung cancer. Such shadows were confirmed to have shrunk or disappeared on CT scan 1-2 months later. Conclusions: The pts who had ever had COVID-19 gradually increased. This was accompanied by an increase in the number of inflammatory shadows that were difficult to differentiate from lung cancer. It is better to follow up patients with CT or CXR for a month instead of immediately examining them. COVID-19 may cause concomitant bacterial or viral pneumonia; COVID-19 may affect the immune mechanisms of healthy individuals.

Use of cell-free tumor DNA in early detection of lung cancer.

e20088 Background: USPSTF recommends annual screening for lung cancer with low-dose computed tomography (LDCT) in adults 50-80 years with 20 pack-year smoking history or current/former smoking in the past 15 years. This prospective study evaluated whether we could detect lung cancer at the time of LDCT screening from cell-free tumor DNA using Guardant Health’s LUNAR-2 assay. Methods: Kaiser Permanente Colorado (KPCO) members with upcoming LDCT screenings were invited via email/phone and recruited into two groups, (1) suspicious lung nodules or (2) no lung nodules. We limited enrollment to patients whose LDCT results were classified under the Lung-RADS (version 1.0) categories of 1-3 (recommended follow-up at 12-month intervals) or category 4 (“suspicious”; recommended follow-up at 3-month intervals). We excluded members with lung nodules &gt; 30mm, those with a history of any hematologic malignancy, history of invasive malignancy within the past 5 years, currently pregnant, or known dementia or cognitive impairment. After informed consent, Guardant Health LUNAR test collection kits were mailed to the participant with sample collection instructions provided. Participants were asked to have their blood drawn on the day of their LDCT visit, or no more than 14 days of the scan. We also collected survey and EHR data on smoking history, LDCT, and other associated factors. The KPCO tumor registry confirmed all reported cancers. Results: The study initiated in September 2020 and ended in 08/2022 with 982 individuals consented and blood samples collected. Participants were on average 68 years old, 56% female, 58% former smokers, and 85% had no personal history of cancer. A total of 15 lung cancer cases and 22 other cancer cases were diagnosed. Data analysis is ongoing and expected to be completed early 2024. Conclusions: This study will demonstrate sensitivity and specificity of the LUNAR-2 assay to detect lung cancer relative to standard of care screening modalities in high-risk populations. We will also evaluate whether factors such as comorbidities, pack year history, or medications affect assay accuracy. The impact of this research can inform blood-based early detection of lung cancer.

Analysis of diagnosis patterns and implications on cancer stage in patients with lung cancer: A single-institution experience.

e22508 Background: Lung cancer is the most common cause of cancer-related death in the US. Patients are often diagnosed at advanced stages, challenging treatment and improving life expectancy. There has been tremendous progress in developing newer treatments; however, it is crucial to emphasize low-dose CT (LDCT) screening as it may improve earlier diagnosis and ultimately lead to better outcomes. Research Question What is the utilization of LDCT for lung cancer screening in newly diagnosed lung cancer patients? Do patients with lung cancer diagnosed after LDCT have earlier-stage disease when compared to patients who did not have LDCT? Methods: We conducted an observational cohort study on all new lung cancer patients seen in our clinic from January 2022 to July 2023 (18 months). Data collected included the age, type of lung cancer (NSCLC/SCLC), reason and method of initial identification of lung mass/nodule, methodology of biopsy, cancer stage, and if the patient was eligible for LDCT. Results: Over the study duration, 143 newly diagnosed lung cancer patients were seen in our oncology clinic. Of these, only 12% (18) patients had LDCT before diagnosis. Amongst these 18 patients, 44% (8) were diagnosed with stage I, two patients were diagnosed with stage II, and 44% (4+4) were diagnosed with stages III and IV. A total of 56% of patients (combined stage I/II) were eligible for curative treatment in this group. The remaining 82% of patients were diagnosed with lung cancer after imaging for other reasons (non-LDCT group). In this group, the most common stage at diagnosis was stage IV, constituting 39% (56) of the patients, followed by patients diagnosed at stage III with 24% (34). Only 37% (combined stage I/II) were eligible for curative treatment in this group. Conclusions: The USPSTF recommends annual lung cancer screening with LDCT for adults aged 50 to 80 years who have a 20-pack-year smoking history and are current smokers or have quit within the past 15 years. In an observational study conducted in 2021 from our institution, we identified a lower utilization of LDCT in eligible patients. We improved the screening rates by more than 50% from baseline with lung navigation intervention. In this study, we show that patients are getting diagnosed with lung cancer from X-rays and CTs performed for reasons including but not limited to chest pain, shortness of breath, workup for pulmonary embolism, and preoperative X-rays. Most patients diagnosed after LDCT (44%) had stage I disease compared to only 18% of patients in the non-LDCT group. We also observed that a significantly higher percentage (56% vs 37%) of patients are eligible for curative treatment (stage I/II) when diagnosed with LDCT. We highlight the importance of LDCT screening potentially offering a curable treatment in patients with lung cancer.

LDCT lung cancer screening implementation in a Veterans Affairs hospital: A quality initiative.

e23238 Background: Lung cancer is the number one cause of cancer related deaths worldwide. United States Preventive Services Task Force (USPSTF) recommends annual Lung Cancer Screening (LCS) with Low Dose Computerized Tomography (LDCT) for adults who are current smokers aged 50 to 80 years with at least 20 pack year smoking history or have quit smoking within the past 15 years. Although LCS is a national initiative for Veteran Affairs (VA) Hospitals, there are several barriers in practice. Methods: The LCS program was established with a dedicated coordinator to provide better access to high-quality in-house screening, while reducing the dependance on expensive community care services and referrals. Smoking history in Tobacco Pack Years (TPY) is updated during a Primary Care Physician (PCP) visit, which triggers a clinical reminder in the electronic medical record for LCS. The LCS coordinator would then receive a consult. After shared decision-making with the patient, physician and coordinator, the patients are scheduled for LDCT. If the results are Lung-RADS 1 (negative), 2 or 3 (benign appearing nodules) the patients are notified of the findings and provided with subsequent follow ups. All Lung RADS 4 (suspicious findings) are discussed in the lung tumor board, which includes radiologist, oncologist, pulmonologist, pathologist, cardio-thoracic surgeon, and fellows in training. The committee determines the follow-up scan interval and/or additional investigations. Results: The performance of our LCS Program from June 2022 to January 2024 was reviewed. 5941 patients were assessed for TPY, of those 1127 patients were eligible for LCS scans and 1032 (93.3%) were enrolled into the LCS Program. 951 LDCT scans have been conducted thus far, this includes 598 annual initial screenings, the remaining are follow ups. 57 patients (6.81%) had Lung-RADS 3 findings and are undergoing nodule tracking. 16 patients (1.91%) required diagnostic work-up which includes a PET scan or biopsy. 14 patients (1.67%) have been diagnosed with cancer. Conclusions: Our LDCT Program showed a high acceptance rate of 93.3%, much of which can be attributed to the multiple layers of screening and shared decision-making processes. Patients received three phone calls and a letter as a reminder of their LDCT appointments. Our radiology department has four dedicated slots for LDCT screening each day which allows for further compliance. TPY documentation was identified as a limiting factor in this process. The LCS coordinator verified the TPY history with the patients which helped overcome this shortcoming. Overall a multidisciplinary team approach contributed to the success of our program.

Artificial intelligence–aided lung cancer screening in routine clinical practice: A pilot of LungFlag at Geisinger.

e13604 Background: Use of low-dose computed tomography (LDCT) in lung cancer screening is recommended for early detection and can reduce mortality. LungFlag (Medial-EarlySign) is a machine-learning risk prediction model that identifies individuals at high risk of non-small cell lung cancer so their care team may recommend LDCT screening. The LungFlag model was developed using data from Kaiser Permanente Southern California and is being implemented in a pilot at Geisinger. Here we provide an overview of the clinical workflow for the LungFlag pilot. Methods: Geisinger has implemented LungFlag into routine clinical practice via integration with the electronic medical record system. This pilot is examining the performance and clinical impact of LungFlag in the first year. LungFlag runs every month to provide risk evaluation for individuals 50 to 80 years old who are eligible for annual lung cancer screening according to US Preventive Services Task Force recommendations. Eligible individuals have a 20 pack-year smoking history, no lung cancer history, and currently smoke or quit within the past 15 years. Patients with cancer history in the past 5 years and those screened or scheduled for screening in the past year are excluded. LungFlag identifies the top 30 individuals with the highest LungFlag scores per month (high-risk patients) and refers them for targeted outreach from a lung cancer screening program nurse navigator. A positive LungFlag result prompts nurse navigator chart review, patient outreach, and coordination with the primary care provider. Flagged individuals are contacted (up to 3 phone calls) and encouraged to receive lung cancer screening. Individuals not flagged by the model (non–high-risk patients) receive usual care consisting of reminders for lung cancer screening during primary care visits without additional targeted outreach and high-risk prioritization. Results: The LungFlag pilot was initiated in August 2023 and will continue until August 2024. As of January 2024, risk profiles of &gt;12,000 patients were analyzed and 180 high-risk patients were identified. Conclusions: This pilot is the first evaluation of the implementation process for the LungFlag model in routine clinical practice. After the pilot, a retrospective observational study is planned to further assess the impact of LungFlag and the associated clinical workflow in identifying high-risk individuals and increasing compliance with LDCT screening among high-risk individuals.

Abstract 981: Robustness of fragmentation-based cell-free DNA approaches to clonal hematopoiesis

Abstract INTRODUCTION: Clonal hematopoiesis (CH) is the result of the clonal expansion of hematopoietic stem cells which acquire and pass on somatically gained mutations, including SNVs as well as arm level losses and gains, defined here as mosaic deletions and amplifications (mDAs). The proportion of blood cells in circulation containing CH alterations increases with age and environmental exposures such as smoking, leading to a higher prevalence in many high-risk cancer screening populations. CH remains a major confounder for mutation-based liquid biopsy tests evaluating circulating cell-free DNA (cfDNA), since these assays are unable to discriminate between mutations originating from the tumor as opposed to CH. While the impact of CH mutations on fragmentation-based methods of detecting ctDNA appears to be limited, the effect of mDAs has not yet been explored. METHODS: To assess the impact of mDAs on screening efforts using whole genome sequencing (WGS) of cfDNA, we performed copy number analyses on cfDNA from plasma collected from 895 individuals consisting of high-risk individuals meeting the USPSTF guidelines for annual lung cancer screening using low-dose computed tomography. From a subset of 203 available donors (157 without cancer and 46 with lung cancer), matched genomic DNA from white blood cells (WBCs) were extracted from the isolated buffy coat and WGS was performed to evaluate whether ploidy in cfDNA plasma is derived from WBCs. Genome-wide fragmentation features (short to long ratios and fragment size densities), coverage-based statistics, and copy number (CN) statistics adjusting for mDAs were calculated (CNadj). Machine learning models to calculate the probability of cancer based on these features were then derived. RESULTS: 3.8% (95% CI 0.9%-6.8%) of individuals without cancer had an mDA in their WBCs that were also observed in the plasma (p &amp;lt; 0.01, permutation test). Fragmentation features were not different in regions with mDAs in individuals without cancer (p = 0.619; permutation test) but were altered in regions of tumor-derived chromosomal changes in patients with cancer (p &amp;lt; 0.01; permutation test). Coverage-based statistics were impacted by mDAs (p &amp;lt; 0.01; Wilcoxon test). Machine learning models fit with CNadj showed improved performance over CN. However, machine learning models fit with fragmentation features compensated for this difference overall showing robustness to mDAs (p = 0.45; bootstrap) demonstrating the robustness of cfDNA fragmentomes for detecting lung cancer. CONCLUSIONS: While coverage-based statistics of WGS analyses of cfDNA may be affected by mDAs, fragmentation-based approaches relying on cfDNA fragment length are robust to effects of CH. CNadj is an improved statistic for detecting tumor-derived chromosomal copy number changes in cfDNA, providing increased specificity by conditioning on fragment size distributions. Citation Format: Stephen Cristiano, Bahar Alipanahi, Jamie E. Medina, Lorenzo Rinaldi, Nicholas Dracopoli, Robert B. Scharpf, Alessandro Leal, Victor E. Velculescu, Jennifer Tom. Robustness of fragmentation-based cell-free DNA approaches to clonal hematopoiesis [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 981.

Knowledge, attitude, and practice of lung cancer screening and associated factors among high-risk population in Lanzhou, China: A cross-sectional study.

This study aimed to assess the knowledge, attitude, and practice (KAP) of high-risk populations toward lung cancer screening in Lanzhou, China. Using convenience sampling, this cross-sectional study enrolled outpatients at high-risk for lung cancer at Lanzhou University Second Hospital between November 2022 and March 2023. An anonymous, self-administered online questionnaire was distributed to each participant via the Sojump website (https://www.wjx.cn/), comprising 40 items to collect demographic information and evaluate KAP toward lung cancer screening. The analyses were descriptive. A total of 577 participants (average age of 61.8 ± 7.1 years; 306 males) were included in the study. The participants' scores for KAP were 4.9 ± 2.2, 27.4 ± 3.0, and 7.0 ± 2.1, respectively. Participants with occupational exposure had significantly lower knowledge score (3.3 ± 2.4 vs 5.2 ± 2.1, P < .001), and practice score (5.6 ± 2.4 vs 7.3 ± 1.9, P < .001) than those without occupational exposure. Participants with smoking or passive smoking history had significantly higher attitude scores (27.6 ± 2.9 vs 25.8 ± 3.2, P < .001) and practice scores (7.1 ± 2.0 vs 6.5 ± 2.5, P = .014) than those without smoking history. A total of 360 (62.4%) participants endorsed the doctors' counseling on lung cancer screening, and 355 (61.5%) participants were willing to have screening for lung cancer as doctors advised. The study revealed that 390 (67.6%) participants identified low-dose computed tomography as the appropriate method for lung cancer screening, while 356 (61.7%) participants believed that X-rays were a reliable screening method for lung cancer. However, 365 (63.3%) participants thought that the treatment outcomes for early and late-diagnosed lung cancer were the same. Additionally, 416 (72.10%) participants believed that annual lung cancer CT scanning is unnecessary. On the other hand, 339 (58.8%) participants expressed concerns about exposure to radiation from CT scans, while 349 (60.5%) participants were worried about the cost of lung cancer screening. Only 142 (24.6%) participants reported having undergone annual lung cancer screening. The high-risk population had limited knowledge and insufficient attitude and practice toward lung cancer screening in Lanzhou, China.

Multilevel approaches to address disparities in lung cancer screening: a study protocol

BackgroundLow-dose computed tomography (lung cancer screening) can reduce lung cancer-specific mortality by 20–24%. Based on this evidence, the United States Preventive Services Task Force recommends annual lung cancer screening for asymptomatic high-risk individuals. Despite this recommendation, utilization is low (3–20%). Lung cancer screening may be particularly beneficial for African American patients because they are more likely to have advanced disease, lower survival, and lower screening rates compared to White individuals. Evidence points to multilevel approaches that simultaneously address multiple determinants to increase screening rates and decrease lung cancer burden in minoritized populations. This study will test the effects of provider- and patient-level strategies for promoting equitable lung cancer screening utilization.MethodsGuided by the Health Disparities Research Framework and the Practical, Robust Implementation and Sustainability Model, we will conduct a quasi-experimental study with four primary care clinics within a large health system (MedStar Health). Individuals eligible for lung cancer screening, defined as 50–80 years old, ≥ 20 pack-years, currently smoking, or quit < 15 years, no history of lung cancer, who have an appointment scheduled with their provider, and who are non-adherent to screening will be identified via the EHR, contacted, and enrolled (N = 184 for implementation clinics, N = 184 for comparison clinics; total N = 368). Provider participants will include those practicing at the partner clinics (N = 26). To increase provider-prompted discussions about lung screening, an electronic health record (EHR) clinician reminder will be sent to providers prior to scheduled visits with the screening-eligible participants. To increase patient-level knowledge and patient activation about screening, an inreach specialist will conduct a pre-visit phone-based educational session with participants. Patient participants will be assessed at baseline and 1-week post-visit to measure provider-patient discussion, screening intentions, and knowledge. Screening referrals and screening completion rates will be assessed via the EHR at 6 months. We will use mixed methods and multilevel assessments of patients and providers to evaluate the implementation outcomes (adoption, feasibility, acceptability, and fidelity).DiscussionThe study will inform future work designed to measure the independent and overlapping contributions of the multilevel implementation strategies to advance equity in lung screening rates.Trial registrationClinicalTrials.gov, NCT04675476. Registered December 19, 2020.

P1.18-04 First Annual Lung Cancer Screening Day in the United States Saturday November 12 2022

P1.18-04 First Annual Lung Cancer Screening Day in the United States Saturday November 12 2022

Adherence to Annual Lung Cancer Screening in a Centralized Academic Program

BackgroundAdherence to lung cancer screening (LCS) protocols is critical for achieving mortality reductions. However, adherence rates, particularly for recommended annual screening among patients with low-risk findings, are often sub-optimal. We evaluated annual LCS adherence for patients with low-risk findings participating in a centralized screening program at a tertiary academic center. Patients and MethodsWe conducted a retrospective, observational cohort study of a centralized lung cancer screening program launched in July 2018. We performed electronic medical review of 337 patients who underwent low-dose CT (LDCT) screening before February 1, 2021 (to ensure ≥ 15 months follow up) and had a low-risk Lung-RADS score of 1 or 2. Captured data included patient characteristics (smoking history, Fagerstrom score, environmental exposures, lung cancer risk score), LDCT imaging dates, and Lung-RADS results. The primary outcome measure was adherence to annual screening. We used multivariable logistic regression models to identify factors associated with adherence. ResultsOverall, 337 patients had an initial Lung-RADS result of 1 (n = 189) or 2 (n = 148). Among this cohort, 139 (73.5%) of Lung-RADS 1 and 111 (75.0%) of Lung-RADS 2 patients completed the annual repeat LDCT within 15 months, respectively. The only patient characteristic associated with adherence was having Medicaid coverage; compared to having private insurance, Medicaid patients were less adherent (adjusted OR = 0.37, 95% CI = 0.15-0.92). No other patient characteristic was associated with adherence. ConclusionOur centralized screening program achieved a high initial annual adherence rate. Although LCS has first-dollar insurance coverage, other socioeconomic concerns may present barriers to annual screening for Medicaid recipients.

Effect of the large waves of COVID-19 on false-positive results in annual lung cancer screening.

e18596 Background: Chest X ray (CXR) has been the most common screen test procedure for detection of lung cancer. We have shown that repeat visitors (R) had a significantly lower proportion of CXR abnormalities requiring medication than the first-time visitors (F) at annual lung cancer screening. (Kimura T. Health Prim Car, 2021). In 2022, Japan experienced three large waves of COVID-19 mainly the Omicron variants (the 6th: Jan-Mar, the 7th: Jul-Sep and the 8th: Oct to present). The later the wave, the larger the scale. The Omicron variant spreads more easily than the original or the Delta variants up to the 5th waves. The hypothesis was that these COVID waves may have influenced lung cancer screening. Methods: Our clinic “MedCity21” is a university outpatient clinic for a complete medical check-up as part of a private health screening program. Of course, we check temperature, respiratory symptoms, and any history of COVID infection and vaccination of the participants (pts). Our facility allows COVID-infected pts to have medical check-ups four weeks after they are cured. The pts with abnormalities detected on CXR were notified by telephone request and invited to our specialty clinic for chest CT scan as further examination. Each year from 2018 to 2022, we examined the varieties of abnormal shadows on CXR and CT scans and compared the differences between 2022 and each year before to 2022 using the chi-squared tests. Results: In 2022, there were 14522 pts of which F and R were 27.1% and 72.9% respectively. The percentage of pts with a history of COVID was 1.68% in January, but gradually increased, reaching a plateau of 20% in October. There were 231pts (1.6%) with CXR abnormalities requiring further investigation. The rates in F and R were 1.3% and 1.7%, respectively. A total of 132 pts (56.7%) of 63 pts in F and 69 pts in R underwent chest CT scans at our facility after the call for recommendation for further investigation. The distribution of CXR and CT variations was consistent with our previous report. There was one confirmed case of lung cancer among F, and 2 among R in 2022. It should be noted that the CT confirmation revealed that there were 10 pts with nodular shadow on CXR, of whom 5 were found to have COVID infection after 1 month follow-up. Conclusions: There was a significant decrease in the number of first-time visitors in 2022 compared to previous years (p &lt; 0.001). The percentage of cases returning to our clinic for CT for further investigation has decreased dramatically (p &lt; 0.001). These were attributed to the large COVID waves. Notably, for the first time in the last 5 years, the detection rates of CXR abnormalities were reversed for R and F. In some cases, nodule shadows were difficult to determine whether they were lung cancer or COVID. The number of people with previous COVID-19 infection will continue to increase. The COVID pandemic and subsequent behavioral changes have affected the way people manage their health status.

CO179 Potential Health and Economic Outcomes of a Blood-Based Genomic Test As a Prescreen for Lung Cancer in the US Medicare Population

Annual screening for lung cancer by low-dose computed tomography (LDCT) reduces mortality. Despite no cost-share for covered individuals, limited availability and frequent ‘false alarm’ findings have impeded widespread adoption, diminishing potential population health gains. We examined a model of the clinical and economic effects of introducing an accessible blood-based genomic test (BGT) used as a pre-screen to support more rapid and refined uptake of LDCT screening within the US Medicare population.

Characteristics of lung cancer in renal transplant recipients.

e20592 Background: Renal transplant recipients (RTRs) are at a higher risk of developing malignancies primarily due to prolonged immunosuppression. Lung cancer while rare in RTR, is associated with significant morbidity and mortality. The primary objective of our study is to analyze the clinical characteristics and outcomes of RTRs who developed lung cancer at our institution. Methods: We retrospectively reviewed 1998 RTRs who underwent transplantation between January 1, 1999, and December 31, 2019, at our institution and identified patients who were diagnosed with lung cancer after transplant. Baseline demographic variables and information related to the renal transplant, the diagnosis and management of lung cancer were collected. Results: Among 1998 RTRs, 10 patients (0.005%) developed lung cancer. A majority of the lung cancer patients identified as male (n = 8), and the median age was 62.5 years. The races of the patients were white (30%, n = 3), African American (50%, n = 5), Hispanic (10%, n = 1), and Native American (10%, n = 1). Concomitant liver transplant was performed in 2 patients, and a concomitant heart transplant was performed in 1 patient. Median time to lung cancer diagnosis after transplant was 67.5 months (range, 12-168). The histology of the lung cancers found were adenocarcinoma (n = 4), squamous (n = 4), and small cell (n = 2). All patients had a history of smoking, with 90% reporting a &gt; 15 pack-year history of smoking and none of them received lung cancer screening. Among the patients with non-small cell lung cancer (NSCLC), 87.5% (n = 7) had early-stage disease, and 12.5% (n = 1) had locally advanced disease (Stage IIIB). Both patients diagnosed with small cell lung cancer had extensive-stage (es-SCLC) disease at the time of diagnosis. Among patients with NSCLC, 2 had genomic tumor profiling performed. Among patients with early-stage NSCLC, 57% underwent upfront surgery, 14% received radiation alone, 14% received neoadjuvant chemotherapy, and 14% received adjuvant chemotherapy. Around 71% (n = 5) remained alive at the last follow up recorded. The patient with stage IIIB NSCLC received chemotherapy and concomitant radiation but had an overall survival (OS) of only 6 months; that patient died of complications related to cancer progression. Both patients with es-SCLC received front-line chemotherapy with carboplatin and etoposide. To our knowledge, 40% (n = 4) of these patients retained their renal graft function. At 1-year from diagnosis, 40% of patients diagnosed with lung cancer were still alive. Conclusions: Lung cancer in RTRs is rare but is associated with significant morbidity and mortality. With the improving life expectancy of RTRs, the incidence of de novo malignancies including lung cancer is likely to increase. Annual screening for lung cancer in high-risk individuals is an important step for early diagnosis. Surgical resection and chemotherapy are well tolerated in patients with lung cancer.

Disparities in lung cancer screening in a diverse urban population and the impact of a community-based navigational program.

6555 Background: Lung cancer (LC) is the leading cause of cancer death in the US in both men and women; causing 25% of all cancer deaths. Annual lung cancer screening (LCS) with a low-dose CT (LDCT) in high-risk individuals (aged 50-80 with a &gt;20 pack-year smoking history) decreases LC deaths by 20% and is recommended by USPSTF. Despite the efficacy, uptake of LDCT remains low at 6% nationally, and 13% in Rhode Island. Patient (pt) and provider perceived barriers, along with racial, ethnic and socioeconomic disparities widen the gap. We evaluated the implementation of a LCS navigation program at an urban community health center (CHC) with a multiethnic, socioeconomically underserved population. Methods: A bilingual (English and Spanish speaking) pt navigator was integrated into routine clinic practice at a large primary care CHC group, across 4 sites, starting in January 2022. The navigator’s role was to assess pt and provider awareness of the LCS process, assess for systemic barriers, and provide navigational support for the LDCT process. Pts eligible for LCS at the CHC from 1/2022 to 12/2022 were retrospective examined; 50 to 80 years and a &gt;20 pack-year smoking history. The navigator administered a questionnaire to assess barriers to LDCT and demographic variables. Results: A total of 360 eligible pts were seen across the CHC practice in 2022, of which 149 (41.4%) agreed to undergo LDCT after counseling and shared decision making and 28% of these (n 101) completed LDCTs. 153 of the eligible pts completed the survey questionnaire. Of these, 50% were females; 40% were Hispanic/Latinx, 40% were non-Hispanic/Latinx and 22% declined to answer. Majority, 61% were white, 10% African American/Black and 28% declined to answer. A sizeable proportion were non-English speaking (34%) and resided in cities with Rhode Island’s lowest per-capita incomes (Pawtucket 48%), Central Falls (32%) and North Providence/Providence (10%). In assessing barriers to LCS, 46% of pts were not aware of the LCS process and 44% were unaware that LCS was covered by health insurance; 58% of eligible pts did not recall their PCP discussing LCS. Of the LDCTs resulted available at the time of analysis, 84% were Lung RADS-1 and 16% Lung RADS-4 category. Conclusions: Our study highlights the unique barriers to LCS in an urban multiethnic community. While access to LCS remains an issue, pt awareness of the lung cancer screening process was the major barrier. A patient navigation program is critical to the success of LCS in a community, by providing education to patients and providers and the necessary logistical support needed in the LDCT process. With a community based navigational program, we demonstrate a significant increase in lung cancer screening rates in our population to 28% as compared to the state LCS rate of 13%. (Supported by the Robert A. Winn Diversity in Clinical Trials Career Development Award).

Prospective evaluation of cell-free DNA fragmentation profiles for lung cancer detection.

e20521 Background: Annual lung cancer screening can save lives, but fewer than 10% of eligible persons participate each year. More widespread screening is hindered by cost, inaccessibility, and uncertainty over individual-level benefit vs risk. Screening rates could be raised by a simple, inexpensive initial blood test, if it were sensitive for cancer detection. The DELFI (DNA evaluation of fragments for early interception) technology uses low-coverage, whole-genome sequencing and machine learning to identify patterns of cell-free DNA (cfDNA) fragmentation associated with cancer. Here we report preliminary cfDNA analysis results from DELFI-L101 (NCT04825834), a prospective, observational, multistate case-control study to train and test DELFI classifiers for lung cancer detection. Methods: Enrollees were ≥50 years old with current or previous smoking histories of ≥20 pack-years and recent or planned chest CT imaging. Medical history was recorded at enrollment, and blood samples were collected for DELFI analysis. Repeated 10-fold cross-validation was used to develop a classifier for lung cancer detection. A split study approach is planned for independent validation of the classifier. Results: At this time, 242 individuals with lung cancer and 652 without cancer have enrolled. Most participants were ≥65 years old, and the proportions of men and women were similar. Lung cancer risk factors were present among both cases and controls. Like the lung cancer screening population, approximately half of lung cancer cases were stage I. Median DELFI scores were higher among individuals with lung cancer than no cancer, overall and across groups stratified by age or body mass index (BMI). Cross-validated area under the receiver operator characteristic curve was 0.81 for lung cancer detection. Clinically meaningful sensitivity to detect lung cancer was attained across all disease stages, with sensitivity increasing stepwise with stage. Conclusions: We developed a classifier based on cfDNA fragmentome patterns analyzed using DELFI that could differentiate between lung cancer cases and controls with cross-validated performance across age groups, BMI categories, and cancer stages. A blood-based DELFI fragmentome test could serve as a low-cost, high-performance blood test with potential to improve lung cancer screening efficiency. Clinical trial information: NCT04825834 .

Navigation program for LDCT lung cancer screening implementation: A quality initiative.

10568 Background: Lung cancer remains the leading cause of cancer-related death worldwide. Despite recommendations from experts, the lung cancer screening has not been well adopted in practice. Methods: We started a pilot program in our cancer center in collaboration with Pulmonary medicine in November 2021 as we identified that the rates of Low Dose CT scan (LDCT) are meager in our community. Two areas that needed attention were identified. The first was the need for shared decision-making by the primary care physician (PCP) before ordering LDCT. The second was the follow-up for patients with positive lung nodules. A lung nodule patient navigator was assigned exclusively for this initiative. Reports were obtained from EPIC every month to identify patients who fit the criteria. PCPs of the respective patients were then reminded to discuss LDCT in the upcoming visit. The lung nodule navigator then followed the ordering and test results of LDCT. A dedicated lung nodule conference discussed all patients with positive lung nodules. Follow-up interventions included referrals to pulmonology, interventional radiology, or further imaging with PET scan. Per guidelines, patients who did not need acute intervention were kept on track for their follow-up CT as recommended. Results: We reviewed our baseline performance in LDCT from January to June 2021.The total screening included 271(32%) patients compared to 836 eligible patients who fit the criteria. From January 2022 to June 2022, out of 749 eligible patients who were expected to meet their PCP, 574(76%) patients received LDCT. Of the patients screened, 436(75%) had their baseline CT chest, with the remaining patients having follow-up CT. Fifteen patients had findings needing immediate intervention. Conclusions: The USPSTF has updated its annual lung cancer screening guidelines with LDCT for adults aged 50 to 80 years who have a 20-pack-year smoking history and current smoker or have quit within the past 15 years. With our approach, the screening rates have more than doubled compared to previous year. LDCT does carry certain risks, including false positive results and unnecessary biopsies; hence shared decision-making is needed before ordering the test. We identified the shared decision process as the rate limiting step across our institution. Our contact with PCP was a significant intervention that improved the screening. The second obstacle was the follow-up for positive LDCT, and we alleviated it with the multidisciplinary lung nodule conference. This process is undoubtedly difficult to achieve without a lung nodule navigator. Each hospital system is unique and has various difficulties implementing screening guidelines. We show that, with the help of a lung nodule navigator, the rates of lung cancer screening can be significantly increased.