後天T790M突變非小細胞肺癌病患的預後：來自真實世界的數據

張立群

doi:10.6342/NTU202102347

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後天T790M突变非小细胞肺癌病患的预後：来自真实世界的数据

The Clinical Outcomes of Patients with Non-small Cell Lung Cancer Harboring Acquired T790M Mutation: The Real-world Data

张立群 , 硕士　　导师：施金元　　

英文 DOI： 10.6342/NTU202102347

非小细胞肺癌；表皮生长因子受体基因； T790M突变；泰格莎；存活分析； Non-small cell lung cancer ； EGFR ； T790M ； osimertinib ； survival

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摘要 │ 参考文献 (30) │ 国际计量

摘要〈TOP〉

背景：多数具有EGFR基因突变的非小细胞肺癌(non-small cell lung cancer)患者在接受表皮生长因子受体(epidermal growth factor receptor)酪胺酸激酶抑制剂(tyrosine kinase inhibitors)治疗後最终仍会产生抗药性，抗药性大多来自於EGFR T790M基因突变。Osimertinib(商品名 Tagrisso，泰格莎)常用於治疗後天T790M基因突变的非小细胞肺癌患者，但投予osimertinib的时机与病患存活时间的相关性仍有待厘清。
研究方法：在这个回溯性的研究中，我们收集了两家医院具有後天T790M基因突变的非小细胞肺癌患者，检视并分析包括病患的基本资料、EGFR基因突变类型、是否接受osimertinib治疗、osimertinib投予的时机、治疗成效等临床资讯。主要结果(primary outcome)定为在从侦测到T790M突变开始计算的不同时段内，比较接受或未接受osimertinib治疗病患的累计死亡率。
研究结果：本研究共纪录了205位具有後天T790M基因突变的非小细胞肺癌患者，其中108位患者进入存活分析。从侦测到T790M突变开始13周内未使用osimertinib的非小细胞肺癌患者其累计死亡率显着高於接受osimertinib治疗的患者 (12.8%和1.7%，p = 0.023)。接受osimertinib治疗的84位患者中，从侦测到T790M突变到开始给予osimertinib治疗之间天数的中位数为56天，以投予osimertinib在侦测到T790M突变起56天内和56天後分组，疾病无恶化存活期(progression-free survival, PFS)的中位数分别为8.2个月和21.8个月，未达到统计学上的显着差异(p = 0.063)；以osimertinib作为侦测到T790M後第一线或第二线以後治疗分组，PFS的中位数分别为10.9个月和9.3个月，两组相当接近(p = 0.950)。多变项分析中，从血浆循环肿瘤DNA检验测得T790M突变的病患，其PFS (风险比率，hazard ratio = 2.79, 95% confidence interval, 1.30-5.95)及存活时间(hazard ratio = 5.27, 95% confidence interval, 2.12-13.15)与由肿瘤组织切片测得T790M突变的病患相比与较短。
结论：对於後天T790M突变的非小细胞肺癌患者，延後投予osimertinib可能会增加患者的死亡率，但以osimertinib作为侦测到T790M突变後第一线或第二线以後的治疗，PFS没有显着的差异，然而侦测到T790M突变的检体来源可能是重要的预後因子。

并列摘要〈TOP〉

Background: Most patients with EGFR-mutated non-small cell lung cancer (NSCLC) receiving epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) therapy would eventually encounter drug resistance, which is frequently caused by EGFR T790M mutation. Osimertinib is frequently used to treat acquired T790M-mutated NSCLC. The correlation between the timing of osimertinib use and survival benefit remains unclear.
Methods: In this retrospective two-center study, we enrolled patients with EGFR-mutated NSCLC harboring acquired T790M mutation. The clinical data were collected and analyzed, including clinical characteristics, types of EGFR mutation, use of osimertinib or not, the timing of osimertinib use, and treatment outcomes. The primary outcome was defined as comparison of cumulative death rate in patients who had and hadn’t received osimertinib within different time interval since T790M mutation detected.
Results: A total of 205 patients with EGFR-mutated NSCLC harboring acquired T790M mutation were identified. Among them, 108 patients were included for survival analysis. Patients who hadn’t received osimertinib within 13 weeks since T790M mutation detected had higher cumulative death rate than those who had received osimertinib (12.8% vs. 1.7%，p = 0.023). For patients received osimertinib therapy (n = 84), the median duration from detection of T790M mutation to osimertinib treatment was 56 days. The median progression-free survival (PFS) showed no significant difference between patient groups receiving osimertinib therapy within and beyond 56 days (8.2 vs. 21.8 months, p = 0.063). The median PFS in patients received osimertinib as first subsequent therapy after T790M detected was similar to those as second subsequent therapy or beyond (10.9 vs. 9.3 months, p = 0.950). In multivariate analysis, the patients with T790M mutation detected from circulating tumor DNA had a shorter PFS (hazard ratio = 2.79, 95% confidence interval, 1.30-5.95) and survival (hazard ratio = 5.27, 95% confidence interval, 2.12-13.15) as compared with those who had T790M mutation detected from tumor tissue.
Conclusions: For NSCLC patients with acquired EGFR T790M mutation, delay in the administration of osimertinib might increase mortality rate. But there was no significant difference in osimertinib PFS between patients received osimertinib as first subsequent therapy or second subsequent therapy or beyond after T790M detected. The specimen from which T790M mutation detected may indicate of a prognostic value.

参考文献 ( 30 ) 〈TOP〉

1. Li S, Li L, Zhu Y, et al. Coexistence of EGFR with KRAS, or BRAF, or PIK3CA somatic mutations in lung cancer: a comprehensive mutation profiling from 5125 Chinese cohorts. Br J Cancer 2014;110:2812-2820.
2. Barlesi F, Mazieres J, Merlio JP, et al. Routine molecular profiling of patients with advanced non-small-cell lung cancer: results of a 1-year nationwide programme of the French Cooperative Thoracic Intergroup (IFCT). Lancet 2016;387:1415-1426.
3. Kris MG, Johnson BE, Berry LD, et al. Using multiplexed assays of oncogenic drivers in lung cancers to select targeted drugs. JAMA 2014;311:1998-2006.
4. Planchard D, Popat S, Kerr K, et al. Metastatic non-small cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol 2018;29 Suppl 4:iv192-iv237.
5. Hanna N, Johnson D, Temin S, et al. Systemic Therapy for Stage IV Non-Small-Cell Lung Cancer: American Society of Clinical Oncology Clinical Practice Guideline Update. J Clin Oncol 2017;35:3484-3515.

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使用DOI作为永久连结

引用含有DOI的文献

DOI可强化引用精确性、增强学术圈连结，并给予使用者跨平台的良好使用经验，目前在全世界已有超过五千万个对象申请DOI。 如想对DOI的使用与概念有进一步了解，请参考 （ ） 。

DOI可强化引用精确性、增强学术圈连结，并给予使用者跨平台的良好使用经验，目前在全世界已有超过五千万个对象申请DOI。如想对DOI的使用与概念有进一步了解，请参考（）。