Biomarker Testing for Non–Small-Cell Lung Cancer Increased Over Time

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Biomarker testing can help guide treatment decisions in patients with advanced non–small-cell lung cancer (NSCLC), and multiple biomarkers have been identified in patient subgroups for targeted therapy.1 Several biomarker testing methods are currently available. Simple tests include a single test to detect a single gene mutation or a low multiplex assay that detects the most common mutation in 1 or 2 genes.1 Complex tests, which include next-generation sequencing (NGS), can detect mutations in multiple genes and may also detect gene fusions or copy number alterations.1 For patients with advanced nonsquamous NSCLC, biomarker testing at a minimum should include ALK and ROS1 rearrangements, EGFR mutation, BRAF mutation, and PD-L1 immunohistochemistry. If NGS is used, RET, MET, HER2, and KRAS should also be assessed.1 Despite multiple society guidelines recommending testing for biomarkers, clinical use of biomarker testing is variable.1 EGFR is the most common targetable mutation, but the most recent surveys (2016) have found that testing of eligible patients ranged from 61% to 87% in select geographical areas.1 The ALK testing rate in 2018 was only 69%.1

To understand current biomarker testing and treatment practices in the United States, a retrospective observational study of 16,882 patients aged ≥18 years with advanced NSCLC was conducted. To be included in the study, patients had to be diagnosed with cancer and seen for ≥1 visit within 90 days of the diagnosis; patients were then followed for ≥90 days. Data were used from the Flatiron Health electronic health record database at OneOncology (OO) community and non-OO Flatiron Health nationwide (NAT) sites. Community sites accounted for 90% of the data collected whereas academic sites accounted for 10%.

For patients with advanced NSCLC, 14,516 were NAT patients and 2366 were OO patients. Overall, testing was 85% at OO and 84% at NAT. NGS testing was 58% at OO and 49% at NAT. Testing for 6 mutations (ALK, BRAF, KRAS, ROS1, EGFR, and PD-L1) was 54% at OO and 50% at NAT. Over time, NGS testing increased for both OO and NAT groups.

When test timing was assessed, 1945 OO patients and 11,376 NAT patients received treatment before test results were available. When evaluating patients who had ≥1 actionable mutations, which included ALK, BRAF, ROS1, and EGFR, 18% of OO and 22% of NAT patients had treatment prior to test results. The most common treatment was cancer immunotherapy plus chemotherapy, which was given to 36% of OO patients and 40% of NAT patients. After test results were received, 33% of OO patients and 45% of NAT patients remained on this treatment. For patients with an actionable mutation who waited until biomarker testing results were received before undergoing treatment, 65% in both groups received targeted treatment.


  1. Pennell NA, Arcila ME, Gandara DR, West H. Biomarker testing for patients with advanced non-small cell lung cancer: real-world issues and tough choices. Am Soc Clin Oncol Educ Book. 2019;39:531-542.

Source: Schwartzberg LS, Yu E, Meyer CS, et al. Evolution of biomarker testing in advanced non-small cell lung cancer (aNSCLC) and metastatic breast cancer (mBC) in U.S. community practices. J Clin Oncol. 2022;40(16 suppl):e18778-e18778.

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