OBJECTIVES: Biomarker testing is increasingly crucial for patients with early-stage non-small cell lung cancer (eNSCLC). This exploratory study aimed to understand biomarker test utilization over time in eNSCLC patients in the real-world setting.

METHODS: Using COTA’s oncology database, this retrospective observational study included adult patients ≥18 years old diagnosed with eNSCLC (disease stage 0-IIIA) between 01/01/2011 and 12/31/2021. The date of the first eNSCLC diagnosis was the study index date. To understand the biomarker test utilization over time, testing rates were reported by the index year for patients who received any biomarker test within 6 months of their eNSCLC diagnosis and by each molecular marker. Biomaker testing methods and test turnaround time were also reported.

RESULTS: Of the 1,031 eNSCLC patients included in the analysis,764 (74.1%) received at least one biomarker test within 6 months of their eNSCLC diagnosis. Overall, EGFR (64%), ALK (60%), PD-L1 (48%), ROS1 (46%), BRAF (40%), MET (39.8%), KRAS (35.2%), RET (22%), HER2 (21%), and PIK3CA (20%) were the ten most frequently tested biomarkers. The proportion of patients undergoing biomarker testing rose from 55.3% in 2011 to 88.1% in 2021. The most commonly performed testing method was Sanger sequencing for EGFR (244, 37%), FISH for ALK (464, 75%) and ROS1 (357, 76%), immunohistochemical (IHC) assay for PD-L1 (450, 90%), and next-generation sequencing (NGS) testing for other biomarkers. The test turnaround time was shortest for IHC (median [IQR]: 9 [7-22] days) but longest for RNA sequencing (median [IQR]: 59 [36-68.8] days). NGS testing had the second-longest turnaround time (median [IQR]: 30 [16-50.5] days).

CONCLUSIONS: This study suggests a high biomarker testing rate among patients with eNSCLC in the U.S. with testing rates for various biomarkers increasing over time during the past decade.