Registry of Genetic Alterations of Taiwan Non-Small Cell Lung Cancer by Comprehensive Next-Generation Sequencing: A Real-World Cohort Study-Taiwan Cooperative Oncology Group T1521.

PURPOSE

Tissue-based next-generation sequencing (NGS) analysis is highly recommended for patients with advanced/metastatic non-small cell lung cancer (NSCLC). We investigated a specific patient population with NSCLC that required tissue-based NGS analysis.

MATERIALS AND METHODS

We enrolled 500 patients with advanced/metastatic (1) epidermal growth factor receptor () mutations or anaplastic large-cell lymphoma kinase () rearrangement-positive NSCLC who had failed at minimum one line of tyrosine kinase inhibitor (TKI) therapy, (2) -negative nonsquamous, and (3) non- or light-smoker patients with squamous NSCLC who were treatment-naïve or had failed at maximum two lines of systemic treatment. These patients were divided into five cohorts. Comprehensive tissue-based NGS testing (ACTOnco+) was conducted.

RESULTS

Cohort 1: EGFR TKI-pretreated -mutated population (50.0%, n = 250), cohort 2: ALK inhibitor-pretreated -positive population (1.6%, n = 8), cohort 3: treatment-naïve -negative population (28.2%, n = 141), cohort 4: pretreated -negative population (16.8%, n = 84), and cohort 5: squamous cell carcinoma (3.4%, n = 17). In cohort 1, 11.2% (28/250) of the patients had amplification, 32.4% (81/250) had been treated with osimertinib, and C797S was detected in 6.2% (5/81) of these patients. In cohort 2, resistance ALK mutation was detected in 37.5% (3/8) of the patients. In cohorts 3 and 4, targetable genetic alterations, including mutation (13.3%), mutation (9.3%), exon 14 skipping (5.3%), G12C mutation (4.4%), fusion (2.7%), fusion (1.8%), and V600E mutation (1.3%), were detected. In cohort 5, exon 14 skipping was detected in 29.4% (5/17) of the patients.

CONCLUSION

This multicenter registration study investigated tissue-based NGS for a specific patient population with NSCLC in Taiwan.