Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLuS2)

部分由于筛查和治疗的最新进展，早期非小细胞肺癌（NSCLC）患者的5年相对生存率每年都在持续增加，NSCLC是全球癌症死亡的主要原因。在美国，指南推荐的计算机断层扫描（CT）成像监测每半年进行一次，为期2年，每年进行一次，为期5年，尽管没有明确的证据表明其在降低死亡率方面的益处，但这种监测在美国正在迅速增加。此外，CT成像监测的临床试验在美国非小细胞肺癌人群中尚未报道。这一研究差距令人担忧，预示着临床指南的证据质量较低。目前，还没有全面的肺癌监测数据源对现实世界的肺癌监测利用模式和下游结果进行编目，这两者对于制定基于证据的治疗意图治疗后的监测建议是必要的。该项目名为“推进不同人群肺癌精准监测和结果”（PLUS2），将为研究、理解和优化肺癌监测和下游结果创造独特的数据源。PLUS2基于PCORI和nci资助的OneFlorida+临床研究联盟（OneFlorida+ Clinical Research Consortium，一个服务于佛罗里达州、佐治亚州和阿拉巴马州的社区实践网络）现有的基础设施和肺癌筛查注册表的初步数据，将利用来自电子健康记录、索赔和系统级因素的多层次数据，用于完成治愈意图治疗的早期非小细胞肺癌患者(n~27,217；2012-2022年（回顾性队列）和2022-2025年（前瞻性队列）中位年龄70岁。该项目的总体目标是评估肺癌监测策略的相对有效性，主要是半年一次的CT监测与每年一次的CT监测，与美国人群中不同早期NSCLC患者的长期预后有关。通过从NCI的肺癌干预和监测建模网络（CISNET）中生成以前不可用的真实世界数据，用于验证的模拟模型，该提案直接响应了改善以患者为中心的肺癌监测候选人决策的呼吁，这些候选人目前监测的净收益尚不确定。本研究为肺癌监测实践的变革奠定了基础。

Due in part to recent advances in screening and treatment, the 5-year relative survival rate for patients with early-stage non-small cell lung cancer (NSCLC), the leading cause of cancer death worldwide, continues to increase each year. The uptake of guideline-recommended computed tomography (CT) imaging surveillance semiannually for 2 years and annually for up to 5 years following curative-intent therapy is increasing rapidly in the U.S., despite unclear evidence regarding its benefit in reducing mortality. Furthermore, clinical trials of CT imaging surveillance have not been reported among U.S. populations with NSCLC. This gap in research is alarming and portends a low quality of evidence in clinical guidelines. Currently, no comprehensive lung cancer surveillance data source exists that catalogs real-world lung cancer surveillance utilization patterns and downstream outcomes, both of which are necessary to develop evidence-based recommendations for surveillance following curative-intent therapy. This project, Advancing Precision Lung Cancer Surveillance and Outcomes in Diverse Populations (PLUS2), will create this unique data source to study, understand, and optimize lung cancer surveillance and downstream outcomes. Building on the extant infrastructure and preliminary data from the lung cancer screening registry of the PCORI- and NCI-funded OneFlorida+ Clinical Research Consortium, a network of community practices that serve Florida, Georgia, and Alabama, PLUS2 will leverage multilevel data from electronic health records, claims, and system-level factors for patients with early-stage NSCLC who have completed curative-intent therapy (n~27,217; median age 70) from 2012-2022 (retrospective cohort) and 2022-2025 (prospective cohort). The overarching goal of the project is to evaluate the comparative effectiveness of lung cancer surveillance strategies, principally semi-annual versus annual CT surveillance, in relation to long-term outcomes among diverse patients with early-stage NSCLC within the U.S. population. By generating previously unavailable real-world data from NCI’s Lung Cancer Intervention and Surveillance Modeling Network (CISNET) for use in validated simulation models, this proposal responds directly to calls to improve patient-centered decision-making in lung cancer surveillance candidates for whom the net benefits of surveillance are currently uncertain. This study is foundational for lung cancer surveillance practice change.