PDF(Pubmed)
Abstract：
UNASSIGNED: To determine the appropriate treatment for patients with advanced/recurrent nonsquamous non‒small-cell lung cancer (NSCLC), a companion diagnostic was conducted to detect driver mutations through genetic testing. In Japan, Oncomine Dx Target Test (DxTT) using next-generation sequencing (NGS) that can comprehensively detect gene mutations or single-gene tests are conducted as companion diagnostics. Furthermore, cost-effectiveness analysis was conducted to compare the cost-effectiveness of Oncomine DxTT using NGS with that of single-gene test in Japan.
UNASSIGNED: The target population included patients with advanced/recurrent nonsquamous NSCLC. A model structure was constructed for the Oncomine DxTT strategy and three single-gene tests (i.e., epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK)/c-ros oncogene 1 (ROS1) rearrangements) with reference to previous studies and the Clinical Practice Guidelines of Lung Cancer 2022 in Japan. The model structure assumed that genetic testing would be conducted and first-line treatment used the drug most recommended in the 2022 Japanese Lung Cancer Clinical Practice Guidelines, depending on the driver mutation,. Model inputs were obtained from the literature and price list in Japan, and cost-utility analysis was conducted.
UNASSIGNED: For the Oncomine DxTT strategy, the expected incremental costs and effectiveness were estimated to be approximately JPY 172,361 (JPY 12,285,228 vs. JPY 12,112,867 for strategies A and B, respectively) and -0.51 quality-adjusted life-year (QALY) per patient (21.93 QALY vs. 22.44 QALY for strategies A and B). As a result, the costs increased but the effectiveness decreased. Therefore, the Oncomine DxTT strategy was dominated by the three single-gene tests. Sensitivity and scenario analyses revealed that the test success rate of Oncomine DxTT affected the results.
UNASSIGNED: The genetic test using Oncomine DxTT before the first-line treatment is not cost-effective compared with the three single-gene tests (EGFR/ALK/ROS1) for patients with advanced/recurrent nonsquamous NSCLC.
UNASSIGNED: The target population included patients with advanced/recurrent nonsquamous NSCLC. A model structure was constructed for the Oncomine DxTT strategy and three single-gene tests (i.e., epidermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK)/c-ros oncogene 1 (ROS1) rearrangements) with reference to previous studies and the Clinical Practice Guidelines of Lung Cancer 2022 in Japan. The model structure assumed that genetic testing would be conducted and first-line treatment used the drug most recommended in the 2022 Japanese Lung Cancer Clinical Practice Guidelines, depending on the driver mutation,. Model inputs were obtained from the literature and price list in Japan, and cost-utility analysis was conducted.
UNASSIGNED: For the Oncomine DxTT strategy, the expected incremental costs and effectiveness were estimated to be approximately JPY 172,361 (JPY 12,285,228 vs. JPY 12,112,867 for strategies A and B, respectively) and -0.51 quality-adjusted life-year (QALY) per patient (21.93 QALY vs. 22.44 QALY for strategies A and B). As a result, the costs increased but the effectiveness decreased. Therefore, the Oncomine DxTT strategy was dominated by the three single-gene tests. Sensitivity and scenario analyses revealed that the test success rate of Oncomine DxTT affected the results.
UNASSIGNED: The genetic test using Oncomine DxTT before the first-line treatment is not cost-effective compared with the three single-gene tests (EGFR/ALK/ROS1) for patients with advanced/recurrent nonsquamous NSCLC.
摘要：
■为了确定晚期/复发性非鳞状非小细胞肺癌（NSCLC）患者的适当治疗方法，通过基因检测进行伴随诊断以检测驱动突变.在日本,使用下一代测序（NGS）的OncomineDx目标测试（DxTT）可以全面检测基因突变或单基因测试作为伴随诊断进行。此外，进行了成本-效果分析,以比较使用NGS的OncomineDxTT与日本单基因检测的成本-效果.
■目标人群包括晚期/复发性非鳞状细胞肺癌患者。为OncomineDxTT策略和三个单基因测试构建了模型结构（即，表皮生长因子受体（EGFR）突变和间变性淋巴瘤激酶（ALK）/c-ros癌基因1（ROS1）重排），参考以前的研究和日本2022年肺癌临床实践指南。模型结构假设将进行基因检测，一线治疗使用2022年日本肺癌临床实践指南中最推荐的药物，根据驱动突变，.模型输入来自日本的文献和价格表，并进行了成本效用分析。
■对于OncomineDxTT策略，预计增量成本和有效性估计约为172,361日元(12,285,228日元与策略A和策略B的12,112,867日元，分别）和每位患者-0.51质量调整生命年（QALY）（21.93QALYvs.22.44策略A和B的QALY)。因此,成本增加，但效果下降。因此,OncomineDxTT策略由三个单基因测试主导。敏感性和情景分析表明，OncomineDxTT的测试成功率会影响结果。
■与三种单基因检测（EGFR/ALK/ROS1）相比，一线治疗前使用OncomineDxTT进行的基因检测对晚期/复发性非鳞状细胞肺癌患者的成本效益不高。
■目标人群包括晚期/复发性非鳞状细胞肺癌患者。为OncomineDxTT策略和三个单基因测试构建了模型结构（即，表皮生长因子受体（EGFR）突变和间变性淋巴瘤激酶（ALK）/c-ros癌基因1（ROS1）重排），参考以前的研究和日本2022年肺癌临床实践指南。模型结构假设将进行基因检测，一线治疗使用2022年日本肺癌临床实践指南中最推荐的药物，根据驱动突变，.模型输入来自日本的文献和价格表，并进行了成本效用分析。
■对于OncomineDxTT策略，预计增量成本和有效性估计约为172,361日元(12,285,228日元与策略A和策略B的12,112,867日元，分别）和每位患者-0.51质量调整生命年（QALY）（21.93QALYvs.22.44策略A和B的QALY)。因此,成本增加，但效果下降。因此,OncomineDxTT策略由三个单基因测试主导。敏感性和情景分析表明，OncomineDxTT的测试成功率会影响结果。
■与三种单基因检测（EGFR/ALK/ROS1）相比，一线治疗前使用OncomineDxTT进行的基因检测对晚期/复发性非鳞状细胞肺癌患者的成本效益不高。
