國家衛生研究院 NHRI:Item 3990099045/15579
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    题名: The registry of genetic alterations of Taiwan NSCLC by comprehensive next-generation sequencing: A real-world cohort study - TCOG T1521 study
    作者: Liao, BC;Chiang, NJ;Chang, GC;Su, WC;Chong, IW;Yang, TY;Luo, YH;Lai, CL;Hsia, TC;Ho, CL;Lee, KY;Hsiao, CF;Yang, JCH
    贡献者: Institute of Population Health Sciences
    摘要: Introduction: Tissue next-generation sequencing (NGS) analysis is highly recommended for patients with advanced/metastatic NSCLC. However, in Taiwan, the single-payer National Health Insurance does not reimburse NGS analysis. Therefore, we conducted a registration study (NCT04849481, Taiwan Cooperative Oncology Group (TCOG) 1521 study) to investigate specific NSCLC populations that required tissue NGS analysis. Methods: We enrolled patients with 1) EGFR or ALK-positive NSCLC who had failed at least one line of tyrosine kinase inhibitor (TKI) therapy but no more than two lines of systemic treatment, 2) EGFR/ALK-negative non-squamous and 3) non- or light-smoker squamous NSCLC patients who were treatment-naïve or had failed no more than two lines of systemic treatment. A comprehensive tissue NGS testing (ACTOnco®+) was conducted, and subsequent treatment and outcomes were recorded. Results: We enrolled a total of 500 patients and categorized them into five cohorts. Cohort 1: EGFR TKI-pretreated EGFR-mutated population (50.2%, N¼251), cohort 2: ALK inhibitor-pretreated ALK-positive population (1.8%, N¼9), cohort 3: treatment-naïve EGFR/ALK-negative population (28.4%, N¼142), cohort 4: pretreated EGFR/ALKnegative population (16.8%, N¼84), and cohort 5: squamous cell carcinoma (3.4%, N¼17). In cohort 1, 11.2% (28/251) of the patients had MET amplification, 32.3% (81/251) had been treated with osimertinib, and EGFR C797S was detected in 6.2% (5/81) of these patients. In cohort 2, resistance ALK mutation was detected in 33.3% (3/9) of the patients. In cohort 3 and 4, targetable genetic alterations, including EGFR mutation (13.3%), ERBB2 mutation (9.3%), MET exon 14 skipping (5.3%), KRAS G12C mutation (4.4%), ROS1 fusion (2.2%), RET fusion (1.8%), and BRAF V600E mutation (1.3%) were detected. In cohort 5, MET exon 14 skipping was detected in 29.4% (5/17) of the patients. Conclusions: This multi-center registration study is the largest study to investigate comprehensive tissue NGS for specific NSCLC populations in Taiwan. The results provide realworld evidence to support the reimbursement of tissue NGS as a diagnostic test for NSCLC patients.
    日期: 2023-11
    關聯: Journal of Thoracic Oncology. 2023 Nov;18(11, Suppl.):S52.
    Link to: https://doi.org/10.1016/j.jtho.2023.09.037
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1556-0864&DestApp=IC2JCR
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