使用反射性下一代测序从NSCLC诊断到基因组检测之间的周转时间

Background: Lung cancer is the leading cause of cancer mortality in both men and women in the United States, accounting for 1 in 5 of all cancer deaths. Identifying driver mutations in lung cancer allows clinicians to choose targeted therapies, offering higher response rates and fewer adverse effects. Timeliness to treatment of non-small cell lung cancer (NSCLC), which contributes approximately 87% of lung cancer cases, is expected to improve outcomes by facilitating biomarker-directed treatment in the first-line setting. In this study, we evaluated and compared the turnaround time (TAT) between NSCLC diagnosis and genomic result reporting before and after the initiation of reflexive next generation sequence (NGS) testing. Methods: A single institution retrospective study was conducted using time zero as the specimen collection date from biopsy/surgical resection to NGS report release date before (N=23) and after (N=26) the implementation of reflexive NGS testing. Reflexive NGS testing was defined as an institutional policy in which a pathologist automatically ordered NGS testing during diagnostic biopsy reporting. Prior to this policy, the NGS testing was ordered at the discretion of the treating oncologist. We used FoundationOne companion diagnostic (CDx), an NGS diagnostic test, to identify tumor mutation profiles to detect biomarkers with FDA-approved targeted therapies. TAT in pre- and post-reflexive cohorts was compared using a two-sample t-test. Results: A total of 49 patients were included, 23 patients before and 26 patients after reflexive testing. The mean TAT from specimen collection to NGS report release date decreased from 31.8 days pre-reflexive to 18.9 days (40.6% reduction, p = 0.001) after implementation of reflexive testing. Median TAT decreased from 31 to 17 days. The range narrowed from 49 to 27 days and standard deviation of TAT decreased from 15 to 6.5 days, indicating a more consistent TAT post-reflexive testing. Evaluating TAT from specimen collection date to order date, the mean TAT decreased from 18.3 days pre-reflexive to 5.53 days (69.8% reduction, p = 0.0001) post-reflexive testing with median TAT decreasing from 15 to 4 days and the range decreasing from 48 to 23 days. The standard deviation of TAT also decreased from 13 to 5 days, showing a more consistent TAT after implementation of reflexive NGS testing. Conclusion: Reflexive NGS testing significantly reduced both ordering time by 69.8% and reporting time by 40.6%. These findings highlight the substantial improvement in diagnostic efficiency and workflow. The reduction in TAT will allow for an earlier initiation of targeted therapies in patients with NSCLC. Future studies will investigate the clinical benefit of reflexive NGS testing in reducing hospitalizations, time to treatment initiation, and improved patient outcomes.