Eli Lilly and Company, Indianapolis, Indiana.
Syneos Health, Morrisville, North Carolina.
J Natl Compr Canc Netw. 2023 Sep;21(9):934-944.e1. doi: 10.6004/jnccn.2023.7039.
Little is known about the impact of up-front biomarker testing on long-term outcomes in patients with advanced or metastatic non-small cell lung cancer (a/mNSCLC). This study compared overall survival (OS) by biomarker testing status and by receipt of guideline-concordant therapy in a large real-world cohort of patients with a/mNSCLC in the United States.
This retrospective study used an a/mNSCLC database derived from real-world electronic healthcare records. Patients diagnosed with nonsquamous a/mNSCLC who initiated first-line therapy on or after January 1, 2015, were included. We describe the testing of patients for actionable biomarkers and whether they subsequently received guideline-recommended first-line treatment. OS was defined as the number of months from the initiation of first-line therapy to the date of death or end of follow-up, and was described using Kaplan-Meier analysis. Multivariable Cox proportional hazard modeling was conducted to compare OS between groups adjusting for baseline covariates; adjusted hazard ratios (HRs) were reported.
A total of 21,572 patients with a median age of 69 years (IQR, 61-76 years) and follow-up of 9.5 months (IQR, 3.5-21.5 months) were included. Among patients in the database, 88% had a record of receiving testing for at least 1 biomarker at any time, and 69% of these patients received testing before or at the start of first-line treatment. The adjusted hazard of death was 30% higher in patients who never (vs ever) received biomarker testing in the database (HR, 1.30; 95% CI, 1.24-1.37), and 12% higher in patients who did not receive (vs did receive) biomarker testing before or at the start of first-line treatment (HR, 1.12; 95% CI, 1.08-1.16). The adjusted hazard of death was 25% higher in patients who did not receive guideline-concordant first-line treatment (vs those who did) after having a biomarker-positive disease (HR, 1.25; 95% CI, 1.13-1.40).
Findings suggest that receipt of first-line treatment that is concordant with biomarker testing results and treatment guidelines is associated with improved survival outcomes in patients with a/mNSCLC in the United States.
关于 upfront 生物标志物检测对晚期或转移性非小细胞肺癌（a/mNSCLC）患者的长期结果的影响知之甚少。本研究比较了在美国一个大型真实世界的 a/mNSCLC 患者队列中，根据生物标志物检测状态和是否接受指南一致的治疗，总生存期（OS）的差异。
本回顾性研究使用源自真实世界电子医疗记录的 a/mNSCLC 数据库。纳入了 2015 年 1 月 1 日或之后开始一线治疗的非鳞状 a/mNSCLC 患者。我们描述了患者对可操作生物标志物的检测情况，以及他们随后是否接受了指南推荐的一线治疗。OS 定义为从一线治疗开始到死亡或随访结束的月数，采用 Kaplan-Meier 分析描述。使用多变量 Cox 比例风险模型，根据基线协变量调整组间 OS 的差异；报告了调整后的危险比（HR）。
共纳入 21572 名中位年龄为 69 岁（IQR，61-76 岁）、随访 9.5 个月（IQR，3.5-21.5 个月）的患者。在数据库中，88%的患者有记录显示至少在任何时候接受过一次生物标志物检测，其中 69%的患者在一线治疗前或开始时接受了检测。与从未（vs 曾）接受数据库中生物标志物检测的患者相比，未接受检测的患者死亡风险高出 30%（HR，1.30；95%CI，1.24-1.37），未在一线治疗前或开始时接受检测的患者死亡风险高出 12%（HR，1.12；95%CI，1.08-1.16）。在一线治疗前或开始时患有阳性生物标志物疾病且未接受指南一致的一线治疗的患者（vs 接受治疗的患者）死亡风险高出 25%（HR，1.25；95%CI，1.13-1.40）。
研究结果表明，接受与生物标志物检测结果和治疗指南一致的一线治疗与改善美国 a/mNSCLC 患者的生存结局相关。
