Low-dose Computed Tomography Screening for Lung Cancer in a Clinical Setting

Lung cancer screening in Europe: hurdles to overcome

Informing Patient Surveillance for the Growing Number of Survivors of Lung Cancer

8553 Background: Lung cancer early detection improves survival, but risk-based low-dose CT screening (LDCT) only identifies a minority of patients. We implemented an ILNP in a community healthcare system, and evaluated its risks and benefits. Methods: Patients with lung lesions on routinely-performed radiologic studies were flagged by radiologists and triaged using evidence-based guidelines. We tracked demographics, clinical characteristics, procedures, complications, and health outcomes. We analyzed ILNP subjects’ eligibility for LDCT by National Lung Screening Trial (NLST), Center for Medicaid Services (CMS), NEderlands Leuvens Screening ONderzoek (NELSON), National Comprehensive Cancer Network (NCCN) Risk Groups 1 and 2 (screening recommended), NCCN Risk Group 3 (screening not currently recommended), and US Preventive Services Task Force (USPSTF) criteria from 2013 and 2020. Statistical analysis used the chi-square test and Kaplan Meier method. Results: From 2015-2020, 13,710 patients were evaluated in the ILNP program: median age, 64 years; 42% male; 65% White, 29% Black; 667 (4.9%) were diagnosed with lung cancer. Lung cancers diagnosed from ILNP were 39% adenocarcinoma / 20% Squamous Cell with clinical stage distribution 49% I, 8% II, 17% III, and 16% IV. 832 (6.1%) had invasive diagnostic testing- CT-guided biopsy (50%), bronchoscopy (30%), and/or EBUS (26%); 11% of the 832 had >1 invasive diagnostic test. The most common complications from invasive testing were pneumothorax and chest tube placement. Only 11%-20% of all ILNP patients would have been eligible for LDCT. In ILNP patients diagnosed with lung cancer, only 33% were eligible for screening by NLST criteria; the proportion increased substantially when USPSTF 2020 or NCCN Group 2 criteria were applied (Table). Compared to NLST, NCCN Group 2 criteria increased screening eligibility among cancer patients by 22% (from 33% to 55%), while only increasing screening eligibility by 6% (from 8% to 14%) in non-cancer patients. Aggregate 1-year and 3-year survival rates for lung cancer patient diagnosed through ILNP were 76% (95% CI: 73, 80) and 64% (95% CI: 59, 69). Conclusions: The ILNP identified early-stage lung cancer more frequently than most LDCT programs, with promising survival rates. The majority of subjects with lung cancer were not eligible for LDCT, we still need to optimize risk-based screening criteria. Even with new, expanded criteria for LDCT, structured ILNP is necessary to expand early detection of lung cancer.[Table: see text]

Introduction: Lung cancer is a major public health problem in the US and disparities exist in lung cancer burden and lung cancer screening (LCS) utilization. African Americans (AA) have the highest lung cancer incidence and mortality compared to other racial and ethnic groups; however, LCS rates were lower among AAs compared to Whites under the 2013 United States Preventive Services Task Force (USPSTF) guidelines. While the expanded 2021 USPSTF criteria will significantly raise the number of AAs eligible for LCS, methods to increase rates of LCS among AA patients will still be needed. We describe the development of the first provider educational tool that focuses on barriers to reduce disparities in LCS. Methods: We completed qualitative interviews with primary care providers (N=9) and AA patients eligible for LCS (N=8; 4 screened, 4 unscreened) to assess barriers to LCS and tobacco cessation. Interviews were recorded and analyzed for common themes, which led to the development of the provider intervention. Results: Among patients, common barriers to LCS were a lack of information on the LCS procedure and associated costs, fear of the results, and transportation issues. Patient barriers to utilization of evidence-based cessation treatments included tobacco use stigma, cost of cessation aids, and inconsistent provider communication. Providers acknowledged time constraints during patient visits, lack of standardized training on documenting tobacco use, and the required LCS shared-decision making conversation as barriers to providing LCS referrals and cessation treatment. Both providers and patients noted that LCS rates may be increased by providing patient-facing information on the screening process and by facilitating provider referrals, which are essential for LCS. Based on these findings, we developed a self-directed 30-minute e-learning Health Disparities module that addresses: 1) disparities in the burden of lung cancer; 2) disparities in smoking patterns and utilization of evidence-based smoking cessation treatments; 3) patient barriers to LCS; and 4) resources for providers to address common LCS barriers (e.g., patient reminders to support scheduling the scan, offering transportation options). Experts in health disparities (N=6) and LCS (N=9) provided detailed critiques of the module content and presentation. Conclusions: We identified barriers to LCS and tobacco cessation from the perspectives of providers and AA patients. These findings informed the development of a brief web-based provider educational module to raise awareness about lung cancer and tobacco-related disparities and to provide resources to reduce barriers in diverse patient populations. We have begun a RCT to compare the Health Disparities module to an existing provider module on LCS to evaluate the impact on primary care providers' knowledge, attitudes, and LCS referrals of AA and White patients. These findings will provide preliminary evidence on provider education that can be easily disseminated to address health disparities in LCS and smoking cessation treatments. Citation Format: Laney Smith, Daisy Dunlap, Randi Williams, Andrea Shepherd, Allison Windels, Maria Geronimo, Vicky Parikh, Chavalia J. Breece, Namita Puran, Eric Anderson, Lucile Adams-Campbell, Kathryn Taylor. Developing provider education to address barriers and reduce disparities in lung cancer screening and smoking cessation treatment among underserved patients [abstract]. In: Proceedings of the AACR Virtual Conference: 14th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2021 Oct 6-8. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr PO-067.

Lung cancer kills more people than any other cancer. Prevention and smoking cessation remains the prime methods to reduce this death toll. The US National Lung Screening Trial (NLST), comparing computed tomography (CT) screening with chest X-ray, yielded a 20 % mortality advantage to individuals in the CT arm. The US Preventive Services Task Force have recommended the implementation of lung cancer screening in individuals of 55 to 80 year of age, based on the NLST selection criteria. However, there is currently an international debate on the how to implement lung cancer screening. Questions on cost-effectiveness need to been answered satisfactorily. The other major outstanding questions which need to be considered are focused on, in this chapter: risk prediction models to identify individuals for CT screening programmes; radiological protocols which utilise volumetric analysis for indeterminate nodules; screening interval and duration of screening. In Europe we need to prepare for lung cancer screening with an integrated smoking cessation policy, as this combined approach will save more lives than any other lung cancer intervention in the near future.

A recent publication found that lung cancer screening of high risk smokers and ex-smokers is cost-effective in Ontario, Canada. The carefully designed modeling by ten Haaf et al. (1) agrees with many recent studies—lung cancer screening saves lives at a reasonable cost. Other studies that were based on either the National Lung Screening Trial (NLST) (2) or the International Early Lung Cancer Action Program (I-ELCAP) (3) results have come to this same conclusion. Of note, ten Haaf presents a scenario (scenario 11) where screening reduces deaths from lung cancer by over 80%, which is consistent with I-ELCAP findings. Several other features of ten Haaf’s work are notable, including his recognition that “false positives” found by lung cancer screening are very rarely harmful, and that improvements in protocols since NLST will likely further improve cost effectiveness.

The China Cancer Screening Trial Feasibility Study

<div>Abstract<p><b>Background:</b> Implementing optimal lung cancer screening programs requires knowledge of the natural history and detectability of lung cancer. This information can be derived from the results of clinical trials with the aid of microsimulation models.</p><p><b>Methods:</b> Data from the Surveillance, Epidemiology, and End Results (SEER) program and individual-level data from the National Lung Screening Trial (NLST) and the Prostate, Lung, Colon, and Ovarian Cancer Screening trial (PLCO) were used to investigate the sensitivity (by histology and stage) of CT and chest radiography (CXR) and the mean preclinical sojourn time (MPST) of lung cancer (by gender, histology, and stage). The MISCAN-Lung model was used to reproduce the lung cancer incidence by method of detection (clinically or screen-detected), gender, histology, and stage in both trials and SEER, by calibrating CT and CXR sensitivity and natural history parameters.</p><p><b>Results:</b> CT sensitivity ranges from 8.83% to 99.35% and CXR sensitivity from 2.51% to 97.31%, depending on histology and stage. CT sensitivity for stage IA is more than 3-fold higher compared with CXR, for all histologies. The total MPST estimates for lung cancer progressing through preclinical stages IA to IV range from 3.09 to 5.32 years for men and 3.35 to 6.01 years for women. The largest difference in total MPST between genders was estimated for adenocarcinoma.</p><p><b>Conclusions:</b> We estimate longer MPSTs for lung cancer compared with previous research, suggesting a greater window of opportunity for lung cancer screening.</p><p><b>Impact:</b> This study provides detailed insights into the natural history of lung cancer and CT screening effectiveness. <i>Cancer Epidemiol Biomarkers Prev; 24(1); 154–61. ©2014 AACR</i>.</p></div>

The United States Preventive Services Task Force (USPSTF) recommends annual low-dose computed tomography (CT) lung-cancer screening, as does the Center for Medicare and Medicaid Services (CMS) and many major medical organizations. The USPSTF criteria, similar to those used for entry into the definitive National Lung Screening Trial, are for persons aged 55-80 years, who currently smoke or quit within the past 15 years, and who have accumulated at least 30 pack-years of cigarette smoking. Risk calculators as compared to micro-simulation modeling as used for the USPSTF can more specifically account for demographic, clinical, and smoking characteristics and personalize risk. The USPSTF criteria may miss smokers at high risk for lung cancer who would have been selected for CT screening by individual risk calculators. Recently, the National Comprehensive Cancer Network guidelines for lung cancer screening added consideration of use of risk models to select ever-smokers for screening. Online risk tools are available to assist individuals and health care providers as to whether lung cancer screening may be helpful. Several lung cancer risk models are available, and comparisons across them have been done. In this presentation, a comparison we performed of the statistical predictive properties of 8 published risk models in 2 large prospective U.S. cohorts will be presented. Identifying a consensus cost-effective risk threshold to define screening eligibility is crucial. Another issue is how best to account for competing morbidities that might make screening less useful. Perhaps a life-years gained approach could help to adjust for this. Additionally, risk models require accurate risk factor data, which are rarely available in electronic health records and may require special collection. It also poses challenges in the health care delivery setting given its complexity. To better capture high-risk smokers and prevent premature deaths from lung cancer, eligibility for lung cancer screening should be based on exceeding a cost-effective risk threshold that balances CT screening benefits and harms, using a lung cancer risk tool validated in the U.S. population. Citation Format: Christine D. Berg. Individualized risk based lung cancer screening: The way forward [abstract]. In: Proceedings of the Fifth AACR-IASLC International Joint Conference: Lung Cancer Translational Science from the Bench to the Clinic; Jan 8-11, 2018; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2018;24(17_Suppl):Abstract nr IA08.

African Americans are undercounted by the existing public health screening guidelines for lung cancer according to a study in the Journal of Thoracic Oncology.1 Current US Preventive Services Task Force (USPSTF) and Centers for Medicare and Medicaid Services guidelines were developed on the basis of results from the National Lung Screening Trial. They recommend low-dose computed tomography screening for individuals aged 55 to 80 years who have a cigarette smoking history of 30 pack-years or longer and for people aged 55 to 77 years who smoked previously and have quit within the past 15 years. However, these guidelines are undercounting African American individuals, who are more likely to start smoking at a later age, smoke fewer cigarettes per day, and have a longer duration of smoking; are less likely to quit; and tend to be diagnosed at an earlier age. A previous Southern Community Cohort study of 48,364 ever smokers demonstrated that a smaller percentage of African American individuals would have met the current USPSTF criteria in comparison with Whites (17% vs 31%).2 Furthermore, after adjustments for both age and smoking history, African American ever smokers are at higher risk for lung cancer than White ever smokers. In the Journal of Thoracic Oncology follow-up study, researchers from the University of Illinois at Chicago conducted a retrospective analysis of 1050 patients with thoracic cancer in their cancer registry. Scientists assessed the cohort to determine whether each case would have been eligible by USPSTF criteria for screening based on age, packyears (average packages of 20 cigarettes smoked per day times years smoked), and quit time. The cohort included Whites, African Americans, Hispanics, and Asians and a small number of individuals from other ethnicities. The analysis used data collected from the PLCOm2012 lung cancer risk prediction model. The model incorporates 11 predictors, including sociodemographics, medical history, and 4 smoking exposure variables. Compared with USPSTF criteria, this model had increased sensitivity for lung cancer risk in the African American cohort and for White ever smokers and thus reduced disparities. Of the 64 African American ever smokers who were ineligible according to USPSTF criteria because they were younger than 55 years, 23.4% would have qualified for screening by the PLCOm2012 model with a risk threshold of 1.7%. Of the 53 African American ever smokers who were ineligible according to USPSTF criteria because they had quit smoking more than 15 years ago, 49.1% would have qualified with the PLCOm2012 model. Lastly, of the 193 African American ever smokers who were ineligible according to USPSTF criteria because their smoking history was less than 30 pack-years, 40.4% would have qualified with the PLCOm2012 model. As a result, researchers encourage broader use of this model in racially diverse populations to help to reduce disparities in both lung cancer screenings and outcomes.

Lung cancer screening feasibility in Australia.

Lung cancer screening (LCS) requires complex processes to identify eligible patients, provide appropriate follow-up, and manage findings. It is unclear whether LCS in real-world clinical settings will realize the same benefits as the National Lung Screening Trial (NLST). To evaluate the impact of process modifications on compliance with LCS guidelines during LCS program implementation, and to compare patient characteristics and outcomes with those in NLST. Retrospective cohort study. Kaiser Permanente Colorado (KPCO), a non-profit integrated healthcare system. A total of 3375 patients who underwent a baseline lung cancer screening low-dose computed tomography (S-LDCT) scan between May 2014 and June 2017. Among those receiving an S-LDCT, proportion who met guidelines-based LCS eligibility criteria before and after LCS process modifications, differences in patient characteristics and outcomes between KPCO LCS patients and the NLST cohort, and factors associated with a positive screen. After modifying LCS eligibility confirmation processes, patients receiving S-LDCT who met guidelines-based LCS eligibility criteria increased from 45.6 to 92.7% (P < 0.001). Prior to changes, patients were older (68 vs. 67years; P = 0.001), less likely to be current smokers (51.3% vs. 52.5%; P < 0.001), and less likely to have a ≥ 30-pack-year smoking history (50.0% vs. 95.3%; P < 0.001). Compared with NLST participants, KPCO LCS patients were older (67 vs. 60years; P < 0.001), more likely to currently smoke (52.3% vs. 48.1%; P < 0.001), and more likely to have pulmonary disease. Among those with a positive baseline S-LDCT, the lung cancer detection rate was higher at KPCO (9.4% vs. 3.8%; P < 0.001) and was positively associated with prior pulmonary disease. Adherence to LCS guidelines requires eligibility confirmation procedures. Among those with a positive baseline S-LDCT, comorbidity burden and lung cancer detection rates were notably higher than in NLST, suggesting that the study of long-term outcomes in patients undergoing LCS in real-world clinical settings is warranted.

Background: Studies on outcomes of lung cancer screening and smoking cessation programs among underserved and ethnic minority populations are scarce. These patients, however, have the greatest potential to benefit from these services. African Americans have the highest incidence and mortality rates for lung cancer, often as a result of multiple factors including factors related to disparities in access to quality care. The aim of this study was to determine clinic utilization rates and smoking cessation practices among underserved and ethnic minority patients referred for paired lung cancer screening and smoking cessation services at a community cancer program. Methods: The Dana-Farber Cancer Institute (DFCI)'s Cancer Care Equity Program (CCEP) added lung cancer screening to the established tobacco treatment arm of its community cancer program, housed in a neighborhood Federally Qualified Community Health Center (FQHC) in 2014. Nearly half (46%) of patients, aged 55 to 77 years who received care at the center in 2015 did not have a recorded smoking history. The paired intervention was offered at no cost to patients. Prospective data approved by the IRB was collected on a secured REDcap database that was designed for the CCEP. Patients referred by primary care providers at the health center had a low-dose computed tomography (LDCT) scan scheduled if they met the U.S. Preventive Services Task Force (USPSTF) criteria for lung cancer screening at their first visit. Concurrently, and at subsequent follow-up visits to review results of LDCT scans, patients who had not quit smoking were encouraged to enroll in the tobacco treatment program (TTP), which is individualized, one-on-one and available in both English and Spanish. A yearly surveillance LDCT plan was established for all participants who had negative scans while those with positive scans (based on American College of Radiology Lung-RADs risk stratification system) received further care at DFCI's main campus. Study outcomes include clinic show rates, smoking status, recommendations for LDCT, attendance at LDCT appointments, willingness to enroll in the TTP, and TTP participation rates. Descriptive statistical analysis on data collected between September 2014 and May 2016 was performed using JMP Pro (version 11, SAS Institute Inc., Cary, NC). Results: Fifty two out of 70 patients referred for lung cancer screening and tobacco treatment presented to the clinic, indicating a no show rate of 26%. Of the 52, 46 (88%) were current smokers. Among 47 (90%) participants who consented to research, mean age was 59.8 years (SD±5.8), 49 % were men, 74% were African American/Black, and 89% were current smokers. Most participants (87%) met the USPSTF criteria and were recommended for LDCT. Of these, 93% attended their appointments and were screened. None of the participants had a positive screen. While 83% of current smokers were screened and 87% initially expressed willingness to enroll in the TTP, only a third (33%) participated in the TTP. Conclusion: Compared to a high percentage of attendance at LDCT screenings, study participants had a low attendance at the TTP despite having expressed willingness to participate in the program. Further studies are needed to elucidate the causative factors for this difference. Additionally, the impressive utilization of a free LDCT service by patients who were referred when compared to the much larger number of patients who would fit into the criteria who were not referred, underscores the importance of mitigating health disparities by improving access to care. Efforts should be made to improve smoking-history taking in order to identify and appropriately refer eligible underserved candidates who might benefit from lung cancer screening and tobacco treatment. Citation Format: Ruth N. Akindele, Ludmila A. Svoboda, Sabrina G. Gonzalez, Christopher S. Lathan. Clinic utilization and smoking cessation practices among ethnic minority patients referred for paired lung cancer screening and tobacco treatment services at a community cancer program. [abstract]. In: Proceedings of the Ninth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2016 Sep 25-28; Fort Lauderdale, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2017;26(2 Suppl):Abstract nr C52.

Benefits and harms of lung cancer screening strategies in Argentina: a modeling study.

Lung cancer is the most common cause of cancer death in the world, with most patients having a dismal prognosis. As many as 40 % of lung cancers are diagnosed in stage IV, with current 5-year survival rates well below 20 %. Conventional chest radiography has been historically derided as a valid screening tool for this dreaded disease. A recent National Cancer Institute-sponsored study known as the Prostate, Lung, Colorectal, and Ovarian cancer screening trial found no benefit from such screening in patients at risk. In recent years, low-dose computed tomography (LDCT) of the chest has emerged as a promising screening tool. Recent evidence from the National Lung Screening Trial (NLST) demonstrated a 20 % reduction in mortality from lung cancer in patients undergoing three rounds of LDCT screening. Opponents of lung cancer screening favor its limited use in the setting of well-designed trials claiming excessive false-positive findings, overdiagnosis, and morbidity and mortality associated with invasive testing. That notwithstanding, leading medical societies such as ASCO and ATS have positioned themselves recently in favor of screening subjects meeting the NLST criteria.