局部 Ablative 疗法,其次是 Osimertinib Rechallenge 在寡进性,EGFR 突变的 NSCLC 中: 一项 2 期研究
Azam Ghafoor1, Nitin Roper2, Chul Kim3
1Thoracic and Gastrointestinal Malignancies Branch (TGMB), Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.
JTO clinical and research reports
|September 29, 2025
概括
局部废除疗法 (LAT) 与 osimertinib rechallenge 结合,对 EGFR 突变的 NSCLC 患有寡进的患者显示出有前途. 循环瘤DNA阴性状态可能预测这种策略的好处,需要进一步调查.
科学领域:
- 在瘤学瘤学.
- 医学研究 医学研究
- 药理学 药理学是指药理学的学科.
背景情况:
- 奥西默提尼布对晚期EGFR突变NSCLC有效,但耐药性很常见.
- 寡头进展在治疗受 osimertinib 治疗的 NSCLC 患者中构成了挑战.
- 局部废除疗法 (LAT) 是克服耐药性的潜在策略.
研究的目的:
- 为了评估LAT对寡头进展的安全性和有效性,然后在EGFR突变的NSCLC中重新挑战 osimertinib.
- 评估这种综合方法的第二次无进展生存 (PFS2) 益处.
- 为了确定治疗反应的预测生物标志物.
主要方法:
- 有望的第二阶段试验,在三个队列中招募了37名EGFR突变NSCLC患者.
- 患者接受了奥西默蒂尼布,与LAT用于寡头进展,其次是奥西默蒂尼布重新挑战.
- 主要终点包括安全性,耐受性和PFS2;次要终点是PFS1和整体反应率.
主要成果:
- 21名患者接受了LAT,PFS2的中位数为3.7个月.
- 确定了一个具有异常长的PFS2的子组,其特点是较低的瘤负担和循环瘤DNA阴性最小残留疾病.
- 大多数与LAT相关的不良事件都是低级的 (1-2).
结论:
- 随着奥西默蒂尼布再挑战的LAT是选择EGFR突变NSCLC患者的可行策略.
- 循环瘤DNA阴性最小残留疾病状态可以作为生物标志物来预测LAT后奥西默提尼布继续治疗的益处.
- 虽然与历史数据相比没有达到主要目标,但在精心挑选的患者中可以考虑LAT.
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