用尼沃卢马布治疗可切除非小细胞肺癌患者的新辅助化疗免疫疗法的安全概况在现实世界中 (CReGYT-04新金星)
Kotaro Nomura1, Takuya Watanabe2, Shinkichi Takamori3
1Department of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.
The Annals of thoracic surgery
|October 31, 2025
概括
这项研究评估了可切除非小细胞肺癌 (NSCLC) 的新辅助化疗免疫疗法. 现实世界的数据显示可行性,可管理的不良事件 (AE),但冠状动脉疾病史预测严重的AE.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床研究 临床研究
背景情况:
- 研究可切除非小细胞肺癌 (NSCLC) 的新辅助化疗免疫疗法.
- 评估现实世界的可行性和不良事件 (AE) 概况.
研究的目的:
- 评估新辅助化学免疫治疗在可切除NSCLC患者中的安全性和有效性.
- 确定严重不良事件 (等级≥3AEs) 的风险因素.
主要方法:
- 在126名可切除II/III期NSCLC患者的多中心回顾性研究中.
- 在2023年3月至2024年7月期间,从29个日本机构收集的数据.
- 对等级≥3AE的安全性,AE概况和风险因素的分析.
主要成果:
- 3级以上与治疗相关的副作用发生在28.6%的患者中,与免疫相关的副作用 (irAEs) 发生在9.5%的患者中.
- 冠状动脉疾病的病史是3级≥3级AE和irAE的显著风险因素.
- 90.5%的患者接受了手术,术后死亡率较低.
结论:
- 新辅助化学免疫疗法在切除性NSCLC的现实环境中是可行的,与临床试验结果保持一致.
- 有临床意义的不良事件发生,冠状动脉疾病史可能预测它们的发生.
- 对AE的预测因素进行进一步的调查是有必要的.
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