Connor B Grady, Wei-Ting Hwang, Joshua E Reuss, Wade Iams, Amanda Cass, Geoffrey Liu, Devalben Patel, Stephen V Liu, Gabriela Liliana Bravo Montenegro, Tejas Patil, Jorge J Nieva, Amanda Herrmann, Kristen A Marrone, Vincent K Lam, William Schwartzman, Jonathan Dowell, Liza C Villaruz, Kelsey Leigh Miller, Jared Weiss, Fangdi Sun, Vamsidhar Velcheti, D Ross Camidge, Charu Aggarwal, Lova Sun, Melina E Marmarelis
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Therefore, we propose rules for determining LOT from real-world data of patients with mNSCLC treated with targeted therapies.</p><p><strong>Methods: </strong>LOT rules were developed through expert consensus using a real-world cohort of 550 patients with ALK+ or ROS1+ mNSCLC in the multi-institutional, electronic medical record-based Academic Thoracic Oncology Medical Investigators Consortium's (ATOMIC) Driver Mutation Registry. Rules were subsequently modified based on a review of appropriate LOT determination. These resulting rules were then applied to an independent cohort of patients with EGFR+ mNSCLC to illustrate their use.</p><p><strong>Results: </strong>Six rules for determining LOTs were developed. Among 1133 patients with EGFR mutations and mNSCLC, a total of 3168 regimens were recorded with a median of 2 regimens per patient (IQR, 1-4; range, 1-13). After applying our rules, there were 2834 total LOTs with a median of 2 LOTs per patient (IQR, 1-3; range, 1-11). 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引用次数: 0
摘要
简介：利用真实世界的数据确定治疗方案（LOT）对于为临床决策提供信息和支持临床研究至关重要。用于确定转移性非小细胞肺癌（mNSCLC）患者治疗方案的现有规则没有考虑到目前治疗中使用的越来越多的靶向疗法。因此，我们根据接受靶向治疗的 mNSCLC 患者的实际数据，提出了确定 LOT 的规则：LOT规则是在多机构、基于电子病历的学术胸部肿瘤医学研究者联盟（Academic Thoracic Oncology Medical Investigators Consortium，ATOMIC）驱动基因突变登记处的550名ALK+或ROS1+ mNSCLC患者的真实世界队列中，通过专家共识制定的。随后，根据对适当 LOT 决定的审查结果对规则进行了修改。然后将这些规则应用于一组独立的表皮生长因子受体（EGFR）+ mNSCLC 患者，以说明其用途：结果：制定了六种确定 LOT 的规则。在1133名表皮生长因子受体（EGFR）突变的mNSCLC患者中，共记录了3168个治疗方案，中位数为每个患者2个治疗方案（IQR，1-4；范围，1-13）。应用我们的规则后，共有 2834 个 LOT，每个患者的中位数为 2 个 LOT（IQR，1-3；范围，1-11）。规则 1-3 使 11% 的治疗方案变更无法推进 LOT。与之前公布的规则相比，5.7%的LOT分配存在差异，主要是在靶向治疗的LOT中：这些规则提供了评估当前治疗模式的最新框架，考虑到了mNSCLC患者越来越多地使用靶向治疗的情况，并促进了根据真实世界数据确定LOT方法的标准化。
Determining Line of Therapy from Real-World Data in Non-Small Cell Lung Cancer.
Introduction: Determining lines of therapy (LOT) using real-world data is crucial to inform clinical decisions and support clinical research. Existing rules for determining LOT in patients with metastatic non-small cell lung cancer (mNSCLC) do not incorporate the growing number of targeted therapies used in treatment today. Therefore, we propose rules for determining LOT from real-world data of patients with mNSCLC treated with targeted therapies.
Methods: LOT rules were developed through expert consensus using a real-world cohort of 550 patients with ALK+ or ROS1+ mNSCLC in the multi-institutional, electronic medical record-based Academic Thoracic Oncology Medical Investigators Consortium's (ATOMIC) Driver Mutation Registry. Rules were subsequently modified based on a review of appropriate LOT determination. These resulting rules were then applied to an independent cohort of patients with EGFR+ mNSCLC to illustrate their use.
Results: Six rules for determining LOTs were developed. Among 1133 patients with EGFR mutations and mNSCLC, a total of 3168 regimens were recorded with a median of 2 regimens per patient (IQR, 1-4; range, 1-13). After applying our rules, there were 2834 total LOTs with a median of 2 LOTs per patient (IQR, 1-3; range, 1-11). Rules 1-3 kept 11% of regimen changes from advancing the LOT. When compared to previously published rules, LOT assignments differed 5.7% of the time, mostly in LOTs with targeted therapy.
Conclusion: These rules provide an updated framework to evaluate current treatment patterns, accounting for the increased use of targeted therapies in patients with mNSCLC, and promote standardization of methods for determining LOT from real-world data.
期刊介绍：
The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report.
Particular areas of interest include:
design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
assessments of harm versus benefit in drug therapy;
patterns of drug utilization;
relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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