ArticlePharmacoepidemiology and drug safety2024
Determining Line of Therapy from Real-World Data in Non-Small Cell Lung Cancer.
Article in Pharmacoepidemiology and drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed.
- Observational
- AI-Enabled Real-World Evidence in Oncology: A Statistical Perspective for Regulatory Decisions.Therapeutic innovation & regulatory science · 2026Review
- Optimisation and validation of line-of-therapy advancement algorithms in advanced/metastatic non-small-cell lung cancer: an I-O Optimise study.ESMO real world data and digital oncology · 2026Article
- Advancing real-world research in thoracic malignancies: learnings from the international I-O Optimise initiative.Future oncology (London, England) · 2025Review
- Changing Treatment and Metastatic Disease Patterns in Patients with EGFR Mutated NSCLC: An Academic Thoracic Medical Investigator's Consortium Registry Analysis.JTO clinical and research reports · 2025Article
Corrections and comments
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Authors and funding
25 authors.
Funding
Abstract
introductionDetermining 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.
methodsLOT 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.
resultsSix 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.
conclusionThese 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.
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