| 龚 磊,潘志文,覃 晶.非小细胞肺癌患者外周血表皮生长因子受体T790M检测与奥希替尼疗效的相关性研究[J].中国肿瘤,2019,28(3):234-239. |
| 非小细胞肺癌患者外周血表皮生长因子受体T790M检测与奥希替尼疗效的相关性研究 |
| Epidermal Growth Factor Receptor T790M Detection in Predicting Efficacy of Osimertinib in Patients with Non-small Cell Lung Cancer |
| 投稿时间：2018-09-25 |
| DOI：10.11735/j.issn.1004-0242.2019.03.A013 |
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| 中文关键词: 奥希替尼 表皮生长因子受体 酪氨酸激酶抑制剂 非小细胞肺癌 |
| 英文关键词:osimertinib epidermal growth factor receptor tyrosine kinase inhibitor non-small cell lung cancer |
| 基金项目:浙江省医药卫生科技面上项目课题资助（2018KY313） |
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| 中文摘要: |
| 摘 要：［目的］ 评估非小细胞肺癌患者第一代表皮生长因子受体-酪氨酸激酶抑制剂（epidermal growth factor receptor-tyrosine kinase inhibitor，EGFR-TKI）获得性耐药后外周血EGFR T790M突变的阳性率和用外周血T790M检测结果预测奥希替尼疗效的可靠性。［方法］ 回顾性分析2017 年3月至2018年6月经第一代EGFR-TKI治疗后获得性耐药且使用超级扩增阻滞突变系统(ultra-amplification refractory mutation system，Ultra-ARMS )进行外周血EGFR T790M检测的原发性非小细胞肺癌患者。评估血T790M阳性患者使用奥希替尼的疗效。［结果］共有103例符合标准的第一代EGFR-TKI获得性耐药患者，其中28例（27.2%，28/103）血T790M阳性，75例（72.8%，75/103）血T790M阴性。血T790M阳性患者中，接受奥希替尼治疗有23例：部分缓解（partial response，PR） 15例，疾病稳定（stable disease，SD）6例，疾病进展（progression of disease，PD） 2例。疾病控制率(disease control rate，DCR) 91.3%，客观有效率（objective response rate，ORR)65.2%。奥希替尼治疗的中位无进展生存时间（progression free survival，PFS） 12.5个月（95%CI：11.2~13.8）。有9例血T790M阴性患者后续进行了组织检测，3例在组织中检测到T790M突变。有6例血T790M阴性的患者虽未再行组织检测，但要求试用奥希替尼靶向治疗，1例患者获得了PR，1例SD（PFS超过5个月）。［结论］对第一代EGFR-TKI获得性耐药后未能再次行组织活检的非小细胞肺癌患者，Ultra-ARMS方法检测血T790M阳性可预测奥希替尼疗效。血T790M检测阴性的患者建议再次取组织进行T790M检测以排除假阴性。组织检测是T790M检测的金标准，血T790M检测可作为补充。 |
| 英文摘要: |
| Abstract：［Purpose］ To detect epidermal growth factor receptor(EGFR) p.Thr790Met point mutation(T790M) in patients with non-small cell lung cancer(NSCLC) and to investigate the correlation between T790M detection and the efficacy of osimertinib. ［Methods］ One hundred and three NSCLC patients，who developed resistance to first generation EGFR-tyrosine kinase inhibitor(EGFR-TKI) and admitted in Zhejiang Cancer Hospital from March 2017 to June 2018，were enrolled in the study. Plasma EGFR T790M was tested by ultra-amplification refractory mutation system(Ultra-ARMS). The efficacy of osimertinib in T790M-positive NSCLC patients was analyzed. ［Results］ Among 103 EGFR-TKI resistant NSCLC patients，plasma T790M was positive in 28 cases(27.2%) and negative in 75 cases(72.8%). In 23 plasma T790M-positive patients receiving osimertinib treatment，there were partial response(PR) in 15 cases，stable disease(SD) in 6 cases and progression of disease(PD) in 2 cases. The disease control rate(DCR) was 91.3%，and the objective response rate(ORR) was 65.2%. The median progression free survival(PFS) of osimertinib was 12.5(95%CI：11.2~13.8) months. Nine plasma T790M-negative patients were subsequently examined with tissue specimens，and 3 of them were T790M-positive. Six plasma T790M-negative patients without tissue tests were treated with osimertinib，among whom 1 achieved PR，and 1 achieved SD(PFS was longer than 5 months). ［Conclusion］ Plasma T790M detection can predict the efficacy of osimeritinib in NSCLC patients with first-generation EGFR-TKI resistance. Patients with plasma negative T790M are suggested to perform tissue T790M test to exclude false negative results. |
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