Lung cancer screening for early detection of suspicious lung nodules in Latin America (LUCAS-LATAM).

Abstract

TPS10631 Background: Lung cancer (LC) remains the leading cause of cancer-related death in the Latin American (LATAM) region, accounting for 1 in 10 cancer deaths, attributable to late stage diagnosis in above 85%. Clinical utility of low-dose CT (LDCT) in early detection of LC has been established. However, these trials primarily focus on smokers, excluding non-smokers, who account for over one-third of LC globally. Recent studies document a need to expand screening criteria. Prevalence of light smokers and non-smokers among LC patients in LATAM is high (35% of patients being non-smokers). Geographic and socio-economic barriers hinder early detection of LC. Despite effectiveness, access to LDCT is limited in LATAM. Artificial intelligence (AI) based algorithms have demonstrated improved accuracy in predicting the risk of LC among patients with an incidental pulmonary nodule (IPN) detected on chest radiographs. Qure.ai has developed a model (qXR) that generates a lung nodule malignancy score (LNMS) based on the nodule's characteristics in a chest X-ray (CXR): low risk or high risk. Methods: Prospective study to assess LC screening with LDCT in LATAM and prospectively evaluate qXR in CXR at the initial visit correlating with the finding of the initial LDCT in patients with other high risk criteria to develop LC. 2000 patients will be recruited in 4 LATAM countries (Mexico 700 pts, Costa Rica 300 pts, Colombia 500 pts, Argentina 500 pts) Inclusion criteria include patients ≥50 years of age with one of the following: a. exposure to wood smoke (at least 100 hours/year), b. family history of LC in a first degree relative, c. COPD and/or emphysema, d. smokers with tobacco index of 10 y or more. Exclusion criteria: a. LC diagnosis or other type of cancer 5 years prior to screening, b. loss of 10% of baseline weight 6 months before, c. ineligible for LDCT, d. life expectancy ≤5 years, and e. previous history of pulmonary nodules. The primary objective of the study is the utility of LDCT-based LC screening in identifying suspicious lung nodules in smokers and non-smokers across LATAM, with secondary objectives including: 1- Utility of qXR-LNMS of CXR for LC risk assessment to exclude low risk patients from LDCT screening, 2- Utility of LDCT-based LC screening in subjects with various risk profiles in LATAM, 3- Prevalence of lung nodules in the study population, 4-Mortality rate in the subjects diagnosed with an anomaly in the LDCT (with or without LC diagnosis). Study design: Visit 1: CXR by qXR and LDCT1 Visit 2: LDCT2 : (12/24 months as applicable ± 2 weeks)(interval of LDCT2 is determined by the findings of the Visit 1) Low risk by qXR and Lung RADS 1 or 2: repeat in 24 months Low risk by qXR and Lung RADS 3, high risk by qXR and Lung RADS 1, 2, 3: repeat in 12 months Telephonic follow-up visits (at 6 month interval post LDCT2 for 2 years) Any Lung RADS 0, 4A, 4B, 4X or S will be assed in a thoracic oncology multidisciplinary team.