Determining Line of Therapy from Real-World Data in Non-Small Cell Lung Cancer.

Area of Science:

• Oncology
• Real-world data analysis
• Clinical trial methodology

Background:

• Accurate determination of lines of therapy (LOT) is essential for clinical decision-making and research in metastatic non-small cell lung cancer (mNSCLC).
• Existing LOT determination methods do not adequately account for the increasing use of targeted therapies in mNSCLC treatment.
• There is a need for updated LOT rules that reflect current mNSCLC treatment paradigms.

Purpose of the Study:

• To propose and validate novel rules for determining LOT from real-world data in patients with mNSCLC, specifically addressing the integration of targeted therapies.
• To establish a standardized framework for LOT determination that enhances the analysis of real-world evidence in mNSCLC.

Main Methods:

• Developed LOT rules through expert consensus using a real-world cohort of 550 ALK+ or ROS1+ mNSCLC patients from the ATOMIC Driver Mutation Registry.
• Refined LOT rules based on expert review and applied them to an independent cohort of EGFR+ mNSCLC patients.
• Utilized electronic medical record data for comprehensive LOT determination.

Main Results:

• Six novel LOT rules were established.
• Application to 1133 EGFR+ mNSCLC patients revealed 2834 total LOTs (median 2 per patient).
• The new rules differed from previous methods in 5.7% of LOT assignments, primarily involving targeted therapies, and identified 11% of regimen changes that did not advance LOT.

Conclusions:

• The developed rules offer an updated framework for evaluating mNSCLC treatment patterns using real-world data.
• These rules effectively incorporate the growing role of targeted therapies in mNSCLC management.
• The proposed methodology promotes standardization in determining LOT from real-world data, crucial for clinical research and decision-making.