Original Study|Articles in Press

Real-world Biomarker Testing Patterns in Patients with Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) in a US Community-based Oncology Practice Setting

Published:March 18, 2023DOI:


      • This real-world study evaluated biomarker testing and targeted therapy in mNSCLC
      • At least one biomarker test was received by 89.4% of patients with mNSCLC
      • Targeted therapy was used in 62.4% of patients with a positive biomarker test
      • Increases in biomarker testing were observed after national guideline updates
      • Despite recent improvements, there remain gaps in biomarker testing and treatment



      : This study was designed to describe real-world changes in biomarker testing among patients with non-squamous, metastatic non-small-cell lung cancer (mNSCLC) in a community oncology setting from 2015 to 2020.

      Patients and Methods

      : This retrospective study randomly selected 500 adult patients diagnosed with non-squamous mNSCLC to undergo chart review and data extraction. Data were extracted and validated by two independent abstractors. Biomarker testing rates were described before and after national guideline updates and FDA approval of targeted agents.


      : At least one biomarker test was received by 89.4% of patients with mNSCLC. Of all patients, 46.6%, 34.6%, and 8.2% received both single-gene and next generation sequencing (NGS)-based testing, single-gene testing only, and NGS-based testing only, respectively. However, there were changes in testing rates at the time of drug approvals for targeted agents. Biomarker testing increased for ALK (45.0% before to 78.3% after ALK-targeted drug approval), BRAF (20.0% to 67.8%), EGFR (20.0% to 78.2%), NTRK (34.6% to 55.7%), and ROS1 (29.6% to 74.2%). Biomarker testing increased after changes were made to national guidelines for BRAF (from 18.8% before to 68.1% after inclusion in guidelines), NTRK (37.2% to 56.5%), and ROS1 (40.8% to 74.5%). Targeted therapy was used in 62.4% of patients with a positive biomarker.


      : Increases in biomarker testing rates were observed relative to targeted agent approvals and national guideline updates. However, many patients with non-squamous mNSCLC did not receive full genotyping in accordance with national guidelines and represent an opportunity to identify reasons and solutions for barriers to care.


      : This real-world chart review study observed increases in biomarker testing after both targeted drug approvals and after inclusion in national treatment guidelines. Despite these improvements, approximately 10% of patients never received any biomarker testing, and more than one third of patients with positive biomarker tests do not receive targeted therapy. Further work is needed to understand barriers in patient care.


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