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表皮生长因子受体(EGFR)突变的非小细胞肺癌患者在EGFR酪氨酸激酶抑制剂(TKI)治疗期间血浆循环肿瘤DNA(ctDNA)中T790M监测的最终报告(JP-CLEAR试验)

Final report on plasma ctDNA T790M monitoring during EGFR-TKI treatment in patients with EGFR mutant non-small cell lung cancer (JP-CLEAR trial).

作者信息

Naka Go, Yokoyama Takuma, Usui Kazuhiro, Ishida Hiroo, Kishi Kazuma, Uemura Kohei, Ohashi Yasuo, Kunitoh Hideo

机构信息

National Center for Global Health and Medicine, Tokyo, Japan.

Kyorin University Hospital, Mitaka, Tokyo, Japan.

出版信息

Jpn J Clin Oncol. 2022 Jul 8;52(7):791-794. doi: 10.1093/jjco/hyac032.

DOI:10.1093/jjco/hyac032
PMID:35323965
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9264253/
Abstract

Osimertinib is active against T790M-positive epidermal growth factor receptor mutant non-small cell lung cancer. We enrolled 122 sensitive epidermal growth factor receptor mutant non-small cell lung cancer patients who were planned to receive or were receiving first-/second-generation epidermal growth factor receptor tyrosine kinase inhibitors without disease progression and monitored plasma T790M every 1-2 months using the cobas® EGFR Mutation Test v2. We previously reported the concordance between T790M status in plasma and tissue. This is the final report on the sensitivity of plasma T790M and the efficacy of sequential osimertinib. The sensitivity was 21.1% (95% confidence interval: 6.1-45.6%). The best overall response was 25.0% (95% confidence interval: 9.8-46.7) in the plasma T790M-positive group and 28.6% (95% confidence interval: 8.4-58.1) in the plasma T790M-negative but tissue T790M-positive group. Median progression-free survival was 7.9 months (95% confidence interval: 4.7-17.5) for the former and 4.4 months (95% confidence interval: 3.0-N.E.) for the latter, with no statistically significant difference (P = 0.74).

摘要

奥希替尼对T790M阳性的表皮生长因子受体突变型非小细胞肺癌有效。我们纳入了122例敏感的表皮生长因子受体突变型非小细胞肺癌患者,这些患者计划接受或正在接受第一代/第二代表皮生长因子受体酪氨酸激酶抑制剂且无疾病进展,每1 - 2个月使用cobas® EGFR Mutation Test v2监测血浆T790M。我们之前报道了血浆和组织中T790M状态的一致性。这是关于血浆T790M敏感性及序贯使用奥希替尼疗效的最终报告。敏感性为21.1%(95%置信区间:6.1 - 45.6%)。血浆T790M阳性组的最佳总体缓解率为25.0%(95%置信区间:9.8 - 46.7),血浆T790M阴性但组织T790M阳性组为28.6%(95%置信区间:8.4 - 58.1)。前者的中位无进展生存期为7.9个月(95%置信区间:4.7 - 17.5),后者为4.4个月(95%置信区间:3.0 - 无数据),差异无统计学意义(P = 0.74)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b798/9264253/dc70f5262875/hyac032f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b798/9264253/dc70f5262875/hyac032f1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b798/9264253/dc70f5262875/hyac032f1.jpg

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Detection of EGFR-Activating and T790M Mutations Using Liquid Biopsy in Patients With EGFR-Mutated Non-Small-Cell Lung Cancer Whose Disease Has Progressed During Treatment With First- and Second-Generation Tyrosine Kinase Inhibitors: A Multicenter Real-Life Retrospective Study.利用液体活检检测第一代和第二代酪氨酸激酶抑制剂治疗后进展的 EGFR 突变型非小细胞肺癌患者中的 EGFR 激活和 T790M 突变:一项多中心真实世界回顾性研究。
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