奥西默蒂尼布加上化疗与奥西默蒂尼布,用于患有同时发生EGFR和TP53突变的晚期NSCLC患者:前性队列研究
Jixian Li1, Xiang Zhan1, Mengqing Shao2
1Shandong Provincial Hospital, Shandong University, Jinan City, 250021, Shandong Province, China.
Scientific reports
|July 1, 2025
概括
将化疗添加到奥西默蒂尼布可能会改善EGFR和TP53共同突变的非小细胞肺癌 (NSCLC) 患者的结果. 这种组合疗法显示出更好的反应率和无进展生存率的趋势,特别是在L858R突变患者中.
科学领域:
- 在瘤学瘤学.
- 遗传学 遗传学 是一个
- 药理学 药理学是指药理学的学科.
背景情况:
- 奥西默提尼布是一种标准的第一线治疗,用于晚期EGFR突变非小细胞肺癌 (NSCLC).
- TP53共同突变与NSCLC患者的存活率较低有关.
- 关于EGFR-TP53共同突变的NSCLC患者的治疗策略和治疗结果的数据有限.
研究的目的:
- 在EGFR突变NSCLC和TP53共同突变的患者中,研究 osimertinib 加化学疗法与 osimertinib 单疗法的疗效.
- 评估这种联合治疗对无进展生存期 (PFS) 和整体反应率 (ORR) 的影响.
主要方法:
- 98名EGFR突变,TP53突变NSCLC患者被随机分为两个组:奥西默蒂尼布加化疗 (Osi+Chemo) 或奥西默蒂尼布单疗法 (Osi).
- 无进展生存率 (PFS) 是主要终点,同时评估了整体应答率 (ORR) 和疾病控制率 (DCR).
- 随访时间平均为19.2个月.
主要成果:
- 氧化+化疗组显示了更高ORR (80.0%对71.7%) 和DCR (91.4%对80.4%) 的趋势,尽管在统计学上并不显著.
- 中位数PFS为Osi+Chemo的26.0个月,而Osi的20.7个月,这一差异没有达到统计学意义 (p=0.34).
- 亚组分析显示,在患有L858R突变的患者中,Osi+Chemo对PFS有显著的益处 (未达到vs17.1个月,p=0.03),但在患有19Del.的患者中没有.
结论:
- 奥西默提尼布加化学疗法在EGFR和TP53共同突变的NSCLC患者中显示出改善ORR和延长PFS的潜力.
- 组合疗法对L858R突变患者特别有希望,在这个子组中显著延长了PFS.
- 需要进一步的研究来证实这些发现,并优化对这一具有挑战性的患者群体的治疗策略.
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