Genentech, Inc, South San Francisco, CA.
Genentech, Inc, South San Francisco, CA.
Clin Lung Cancer. 2021 May;22(3):e470-e480. doi: 10.1016/j.cllc.2020.06.019. Epub 2020 Jun 29.
Targeted therapy for patients with non-small-cell lung cancer (NSCLC) harboring ROS proto-oncogene 1 (ROS1) rearrangements was approved in 2016. However, little is known about real-world ROS1 testing practices in United States community practice. We aimed to characterize ROS1 testing rates and identify potential barriers to ROS1 testing.
Flatiron Health's de-identified electronic health record-derived database was used to identify patients diagnosed with advanced NSCLC from July 2016 through December 2018 who received systemic treatment in a community practice setting. ROS1 and other biomarker testing was recorded. Regression analysis identified demographic and clinical characteristics associated with occurrence of ROS1 testing, longer time (≥ 25 days) from diagnosis to ROS1 result, and initiation of therapy prior to ROS1 result.
Among 11,409 patients, documented ROS1 testing rates increased during the study period in squamous (from 30% to 48%) and nonsquamous (63% to 78%) histologies. Patients who were older, male, black, or with squamous histology, higher Eastern Cooperative Oncology Group score, recurrent disease, or history of smoking were significantly less likely to be tested. Among patients not tested for ROS1, 63% were tested for other biomarkers. Use of next-generation sequencing, older age, Hispanic/Latino ethnicity, squamous histology, de novo disease, and smoking history predicted longer time to test result post-diagnosis. Patients with delayed results were 9.7 times more likely to receive treatment prior to ROS1 test result.
In real-world practice, some patient subgroups may be less likely to receive timely ROS1 testing and to be identified for potential targeted therapy.
针对携带 ROS1 原癌基因 1（ROS1）重排的非小细胞肺癌（NSCLC）患者的靶向治疗于 2016 年获得批准。然而，对于美国社区实践中 ROS1 检测的实际情况知之甚少。我们旨在描述 ROS1 检测率并确定 ROS1 检测的潜在障碍。
使用 Flatiron Health 的去识别电子健康记录衍生数据库，从 2016 年 7 月至 2018 年 12 月，确定在社区实践环境中接受系统治疗的晚期 NSCLC 患者。记录了 ROS1 和其他生物标志物检测。回归分析确定了与 ROS1 检测发生、从诊断到 ROS1 结果的时间（≥25 天）以及在 ROS1 结果之前开始治疗相关的人口统计学和临床特征。
在 11409 名患者中，在鳞癌（从 30%到 48%）和非鳞癌（从 63%到 78%）组织学中，记录的 ROS1 检测率在研究期间有所增加。年龄较大、男性、黑人或鳞癌、较高的东部合作肿瘤学组评分、复发性疾病或吸烟史的患者，进行检测的可能性显著降低。在未进行 ROS1 检测的患者中，有 63%的患者进行了其他生物标志物检测。使用下一代测序、年龄较大、西班牙裔/拉丁裔、鳞癌组织学、初发性疾病和吸烟史预测了诊断后获得检测结果的时间较长。延迟获得结果的患者在 ROS1 检测结果之前接受治疗的可能性是前者的 9.7 倍。
在真实实践中，一些患者亚组可能不太可能及时接受 ROS1 检测，也不太可能被确定为潜在的靶向治疗对象。
