Real-world Data of the Lung Cancer Compact Panel™ in Non-small Cell Lung Cancer Using Tissue Samples.

Abstract

Background/aim: Multiple companion diagnostics are essential for detecting genetic alterations and guiding personalized treatment in patients with non-small cell lung cancer (NSCLC). The Lung Cancer Compact Panel™ (LCCP) is a newly developed multiple companion diagnostic tool designed to detect genetic mutations in NSCLC with high sensitivity, compatible with tissue and cytological samples. There has been no large-scale validation of the LCCP that includes tissue samples. This study analyzed LCCP data including tissue samples under real-world clinical conditions to examine its characteristics and usefulness.

Patients and methods: We retrospectively analyzed consecutive NSCLC cases tested with the LCCP at a single institution between April 2023 and July 2024. Patient data, including histological type, genetic abnormalities, allele frequency, and program death ligand 1 expression, were collected from pathology records and electronic medical systems. Tissue specimens were used in cases where tumor content exceeded 5%.

Results: Of the 317 cases, 154 (48.6%) harbored genetic abnormalities. The most common mutation was epidermal growth factor receptor (EGFR) major mutations (n=63). Among lung adenocarcinoma cases, 126 (70.0%) had genetic abnormalities. Fifteen patients had multiple coexisting genetic abnormalities. Notably, 13 patients had low allele frequencies (<2.5%). Nine variants were detected in 30 EGFR exon 19 deletion positive cases, three of which were undetectable by other multiple companion diagnostics. The LCCP demonstrated an ability to detect genetic abnormalities, even in cases with low tumor content (≥5%) compared to Oncomine DxTT and FoundationOne (≥30%), identifying rare EGFR exon 19 deletions and multiple coexisting mutations.

Conclusion: These findings highlight LCCP's potential to improve personalized treatment strategies for NSCLC.