Real-World Data Shows Significant Increase of Biomarker Testing in Past Decade for NSCLC


Looking at real-world data, researchers identified a large increase of biomarker testing for patients with early-stage non–small cell lung cancer, which indicates a continuing trend toward personalized treatment.

Over the past decade, a continuous increase of biomarker testing for patients with early-stage non–small cell lung cancer (NSCLC) suggests a real-world trend toward personalization of treatment for these patients, according to an analysis of real-world data.1

Presented at the 2023 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) meeting in Boston, Massachusetts, researchers conducted a retrospective observational study of a de-identified electronic medical record database from COTA Healthcare of adult patients diagnosed with early-stage NSCLC between January 1, 2011, to December 31, 2021.

Initially, 1200 patients with early-stage NSCLC were identified in the COTA database, with early-stage NSCLC defined as patients with a disease stage of 0-IIIA at the time of their diagnosis. However, after excluding patients with an unspecified cancer stage, those who had biomarker testing not in the prespecified time range, no evidence of interaction with their healthcare system after 90 days or survival less than 30 days after diagnosis, and patients that did not enroll in a clinical trial within 182 days of diagnosis, 1031 patients were used for the real-world analysis.

The majority of patients, 74.1% (n = 764), had at least 1 biomarker tests within 6 months of their diagnosis. The majority of patients were 65-years-old or older, with 91.8% being white and 81.4% had a history of tobacco use. The most common testing method was the use of Sanger sequencing for patients’ disease with an EGFR mutation (n = 244), fluorescent in situ hybridization (FISH) for ALK (n = 464) and ROS1 (n = 357), while immunohistochemistry was used to identify the level of PD-L1 (n = 450), and next generation sequencing was used for the remaining mutations. 

The most frequent biomarkers that appeared in testing were EGFR (64%), ALK (60%), PD-L1 (48%), ROS1 (46%), BRAF (40%), MET (35%), KRAS (29%), RET (22%), HER2 (21%), and PIK3CA (20%). These biomarkers also make up some of the most common biomarkers, along with neurotrophic tropomyosin kinase receptors (NTRK), found for patients with adenocarcinoma, which is a subtype of NSCLC.2

Turnaround time for the tests was shortest for patients given immunohistochemistry with a median IQR range of 7-22 days, while the longest was RNA sequencing with a median IQR range of 36-68.8 days. In total, 763 patients were given the most used biomarker tests for either EGFR, ALK, PD-L1, ROS1, and BRAF, and the majority of patients received their tests prior to the start of systemic therapy.

Patients tested for EGFR had a median of 43 days between the start of their test and initiation of systemic therapy, in comparison, ALK tests had a median of 43 days, PD-L1 was 44 days, ROS1 was 43 days, and BRAF was 41. In all categories, most of these patients were then started with chemotherapy with a small number of patients on non-chemotherapy systemic treatments for their early-stage NSCLC.

"We observed a high biomarker testing rate among patients with eNSCLC in the US, with testing rates for various biomarkers increasing over time during the past decade," explained Yilin Chen, MPH, the study coauthor and a PhD candidate from the Comparative Health Outcomes, Policy, and Economics Institute, University of Washington. "This indicates a continuous trend towards personalization of treatment decisions in the NSCLC landscape."

Overall, the proportion of patients who were given biomarker testing rose from 55.3% in 2011 to 88.1% in 2021. The test with the largest increase in the past decade was EGFR testing with a 64% increase in patients undergoing EGFR biomarker testing. A 60% increase was seen for patients being tested for ALK, while there was just a 48%, 46%, 40%, 35%, and 29% increase of testing in the past decade for PD-L1, ROS1, BRAF, MET, and KRAS. The smallest increase was seen for the testing of NTRK3 fusions with just a 4% increase from 2011 to 2020.

According to the researchers, the study demonstrates that the overall large increase in this testing shows the widespread use of biomarker testing outside of clinical trials. Moreover, this fills a gap in real-world knowledge of these data for this patient population.

However, they also cautioned that future research is needed to see if biomarker testing has improved physicians’ treatment decisions and the long-term survival outcomes of patients with NSCLC. To that end, a manuscript developed from the study findings has been officially accepted for publication in the Oncology and Therapy journal.


1. Yan J, Jin Y, Lo E, et al. Increased Real-World Biomarker Testing Test Utilization in Patients with Early-Stage Non–Small Cell Lung Cancer in the United States, 2011-2021. Presented at: 2023 International Society for Pharmacoeconomics and Outcomes Research; May 7-10, 2023. Boston, MA.

2. Lung Cancer Biomarker Testing. American Lung Cancer Association. November 17, 2022. Accessed: May 8, 2023.

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