Kunimasa Kei, Matsumoto Shingo, Kawamura Takahisa, Inoue Takako, Tamiya Motohiro, Kanzaki Ryu, Maniwa Tomohiro, Okami Jiro, Honma Keiichiro, Goto Koichi, Nishino Kazumi
Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan.
Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Lung Cancer. 2023 May;179:107190. doi: 10.1016/j.lungcan.2023.107190. Epub 2023 Apr 8.
To investigate the clinical performance of the AMOY 9-in-1 kit (AMOY) in comparison with a next-generation sequencing (NGS) panel in lung cancer patients.
Lung cancer patients enrolled in the LC-SCRUM-Asia program at a single institution were analyzed for the success rate of AMOY analysis, the detection rate of targetable driver mutations, the turn around time (TAT) from specimen submission to the result reporting, and the concordance rate of results with the NGS panel.
Of the 406 patients included in the analysis, 81.3% had lung adenocarcinoma. The success rates of AMOY and NGS were 98.5% and 87.8%, respectively. With AMOY, genetic alterations were detected in 54.9% of cases. Of the 42 cases in which NGS analysis failed, targetable driver mutations were detected by AMOY in ten cases through analysis of the same sample. Of the 347 patients for whom the AMOY and NGS panels were successful, 22 showed inconsistent results. In four of the 22 cases, the mutation was detected only in the NGS panel because AMOY did not cover the EGFR mutant variant. Mutations were detected only by AMOY in five of the six discordant pleural fluid samples, with AMOY having a higher detection rate than NGS. The TAT was significantly shorter five days after AMOY.
AMOY had a higher success rate, shorter turnaround time, and higher detection rate than NGS panels. Only a limited number of mutant variants were included; thus be careful not to miss promising targetable driver mutations.
旨在比较AMOY 9合1试剂盒（AMOY）与下一代测序（NGS）检测肺癌患者的临床性能。
对单机构参与LC-SCRUM-亚洲项目的肺癌患者进行分析，评估AMOY分析成功率、可靶向驱动基因突变检测率、从样本提交到结果报告的周转时间（TAT）以及与NGS检测结果的一致性。
纳入分析的406例患者中，81.3%为肺腺癌。AMOY和NGS的成功率分别为98.5%和87.8%。使用AMOY，54.9%的病例检测到基因改变。在NGS分析失败的42例病例中，通过对同一样本分析，AMOY检测到10例可靶向驱动基因突变。在AMOY和NGS检测成功的347例患者中，22例结果不一致。在这22例中的4例中，仅在NGS检测中检测到突变，因为AMOY未覆盖EGFR突变变体。在6例不一致的胸水样本中，有5例仅通过AMOY检测到突变，AMOY的检测率高于NGS。AMOY检测后的TAT显著缩短了5天。
与NGS检测相比，AMOY具有更高的成功率、更短的周转时间和更高的检测率。但仅包含有限数量的突变变体；因此要注意避免遗漏有潜在靶向价值的驱动基因突变。
