Therascreen 切换至 Cobas v2 后对 EGFR-TKs 伴随诊断检测的临床影响。
Clinical influence of switching companion diagnostic tests for EGFR-TKs from Therascreen to Cobas v2.
机构信息
Department of Thoracic Medical Oncology, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
出版信息
Thorac Cancer. 2021 Mar;12(6):906-913. doi: 10.1111/1759-7714.13797. Epub 2021 Feb 2.
BACKGROUND
Several companion diagnostic (CDx) tests for epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) have been approved. In our institute, the CDx test for EGFR-TKIs was changed from the Therascreen test (Therascreen) to the Cobas EGFR v2 test (Cobas) because only Cobas was approved for the use of osimertinib in patients with EGFR-mutated non-small cell lung cancer (NSCLC) with T790M mutations. The clinical influence of switching the CDx test has not yet been examined comprehensively.
METHODS
All serial patients with lung cancer tested for EGFR mutations with CDx tests between February 2014 and February 2016 at the Cancer Institute Hospital of the Japanese Foundation for Cancer Research (JFCR) were enrolled in this analysis.
RESULTS
Therascreen was used as a CDx test for EGFR-TKI therapy in 607 patients between February 2014 and January 2015, and Cobas was used in 621 patients between February 2015 and February 2016. EGFR mutations were detected in 218 patients (35.9%) and 244 patients (39.3%) tested with Therascreen and Cobas, respectively. At the initial diagnosis, 400 and 459 patients were tested with Therascreen and Cobas, respectively. EGFR mutation subtypes, including del19, L858R, and others, were detected in 13.0%, 17.0%, and 2.5% of patients using Therascreen and 17.4%, 14.4%, and 1.5% of patients using Cobas, respectively.
CONCLUSIONS
No significant impact of switching from Therascreen to Cobas as the CDx test for EGFR mutations in clinical practice was observed. However, the detection pattern of the EGFR mutation subtypes between the two CDx tests was slightly different.
KEY POINTS
SIGNIFICANT FINDINGS OF THE STUDY: We examined the influence of changing the EGFR test in 1228 patients in total. The detection rate of EGFR mutations was similar. However, the detection pattern for EGFR subtype mutations was slightly different between the two tests.
WHAT THIS STUDY ADDS
Switching CDx tests from target polymerase chain reaction (PCR)- to next-generation sequencing (NGS)-based methods may lead to obvious changes in clinical practice. When the CDx test is required to change, the investigation of this influence is warranted in future studies.
背景
已经批准了几种用于表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs）的伴随诊断（CDx）测试。在我们的研究所，EGFR-TKIs 的 CDx 测试从 Therascreen 测试（Therascreen）更改为 Cobas EGFR v2 测试（Cobas），因为只有 Cobas 被批准用于治疗 EGFR 突变的非小细胞肺癌（NSCLC）患者的奥希替尼，这些患者具有 T790M 突变。切换 CDx 测试的临床影响尚未得到全面检查。
方法
本分析纳入了 2014 年 2 月至 2016 年 2 月期间在日本癌症基金会癌症研究所（JFCR）使用 CDx 测试检测 EGFR 突变的所有连续肺癌患者。
结果
Therascreen 于 2014 年 2 月至 2015 年 1 月期间用于 607 例 EGFR-TKI 治疗的 CDx 测试，而 Cobas 于 2015 年 2 月至 2016 年 2 月期间用于 621 例患者。Therascreen 和 Cobas 分别检测到 218 例（35.9%）和 244 例（39.3%）患者存在 EGFR 突变。在初始诊断时，分别有 400 例和 459 例患者接受了 Therascreen 和 Cobas 检测。Therascreen 检测到的 EGFR 突变亚型包括 del19、L858R 和其他，分别占患者的 13.0%、17.0%和 2.5%，Cobas 检测到的分别为 17.4%、14.4%和 1.5%。
结论
在临床实践中，从 Therascreen 切换到 Cobas 作为 EGFR 突变的 CDx 测试未观察到明显的影响。然而，两种 CDx 测试之间 EGFR 突变亚型的检测模式略有不同。
关键点
研究的重要发现：我们总共检查了 1228 例患者的 EGFR 检测变化的影响。EGFR 突变的检出率相似。但是，两种测试之间 EGFR 亚型突变的检测模式略有不同。
此项研究增加的内容
从靶向聚合酶链反应（PCR）到下一代测序（NGS）的 CDx 测试的转换可能会导致临床实践发生明显变化。在需要更改 CDx 测试时，在未来的研究中需要调查这种影响。
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