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.

IF 3.2 Q2 ONCOLOGY JCO Global Oncology Pub Date : 2024-09-01 Epub Date: 2024-09-30 DOI:10.1200/GO.24.00125

Bin-Chi Liao, Nai-Jung Chiang, Gee-Chen Chang, Wu-Chou Su, Yung-Hung Luo, Inn-Wen Chong, Tsung-Ying Yang, Chun-Liang Lai, Te-Chun Hsia, Ching-Liang Ho, Kang-Yun Lee, Chin-Fu Hsiao, Fan-Chen Ku, Wei-Tse Fang, James Chih-Hsin Yang

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Abstract

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 (EGFR) mutations or anaplastic large-cell lymphoma kinase (ALK) rearrangement-positive NSCLC who had failed at minimum one line of tyrosine kinase inhibitor (TKI) therapy, (2) EGFR-/ALK-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 EGFR-mutated population (50.0%, n = 250), cohort 2: ALK inhibitor-pretreated ALK-positive population (1.6%, n = 8), cohort 3: treatment-naïve EGFR-/ALK-negative population (28.2%, n = 141), cohort 4: pretreated EGFR-/ALK-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 MET amplification, 32.4% (81/250) 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 37.5% (3/8) of the patients. In cohorts 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 (2.7%), 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.

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

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台湾非小细胞肺癌基因变异的全面新一代测序登记：真实世界队列研究-台湾肿瘤合作组织 T1521。

目的：基于组织的新一代测序（NGS）分析被强烈推荐用于晚期/转移性非小细胞肺癌（NSCLC）患者。我们对需要进行基于组织的 NGS 分析的特定 NSCLC 患者群体进行了调查：我们招募了 500 名晚期/转移性（1）表皮生长因子受体（EGFR）突变或无性大细胞淋巴瘤激酶（ALK）重排阳性的 NSCLC 患者，这些患者至少接受过一次酪氨酸激酶抑制剂（TKI）治疗失败；（2）EGFR/ALK 阴性的非鳞癌患者；（3）非吸烟或轻度吸烟的鳞癌 NSCLC 患者，这些患者未经治疗或至少接受过两次系统治疗失败。这些患者被分为五个队列。进行了基于组织的全面 NGS 检测（ACTOnco+）：队列 1：经 EGFR TKI 治疗的 EGFR 突变人群（50.0%，n = 250）；队列 2：经 ALK 抑制剂治疗的 ALK 阳性人群（1.6%，n = 8）；队列 3：治疗无效的 EGFR-/ALK 阴性人群（28.2%，n = 141），队列 4：EGFR-/ALK 阴性预处理人群（16.8%，n = 84），队列 5：鳞癌（3.4%，n = 17）。在队列 1 中，11.2%（28/250）的患者有 MET 扩增，32.4%（81/250）的患者接受过奥希替尼治疗，其中 6.2%（5/81）的患者检测到表皮生长因子受体 C797S。在队列 2 中，37.5%（3/8）的患者检测到耐药性 ALK 突变。在队列 3 和队列 4 中，检测到了可靶向的基因改变，包括表皮生长因子受体突变（13.3%）、ERBB2 突变（9.3%）、MET 14 号外显子跳越（5.3%）、KRAS G12C 突变（4.4%）、ROS1 融合（2.7%）、RET 融合（1.8%）和 BRAF V600E 突变（1.3%）。在队列 5 中，29.4% 的患者（5/17）检测到 MET 14 号外显子跳变：这项多中心登记研究调查了台湾特定 NSCLC 患者群体中基于组织的 NGS。

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