诱导化疗-免疫疗法随后的化疗-放射疗法和免疫疗法维护在第三阶段NSCLC (APOLO):一个第二阶段试验
Mariano Provencio1, Begoña Campos2, María Guirado3
1Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain. mprovenciop@gmail.com.
Nature communications
|December 23, 2025
概括
在标准治疗之前添加化疗免疫疗法,改善了不可切除的第三阶段非小细胞肺癌 (NSCLC) 患者的无进展生存率. 这一诱导阶段显示出有前途的安全性和疗效,这表明了NSCLC的新治疗方法.
科学领域:
- 在瘤学瘤学.
- 胸部外科手术 胸部外科手术
- 医学瘤学 医学瘤学
背景情况:
- 无法切除的第三阶段非小细胞肺癌 (NSCLC) 的标准治疗包括化疗-放射治疗 (CT-RT),然后进行免疫疗法 (IO) 维护.
- 在标准治疗之前研究新的诱导疗法可能会提高晚期NSCLC的治疗结果.
研究的目的:
- 评估在不可切割的第三阶段NSCLC中,在同时进行化学放射治疗 (CT-RT) 和免疫治疗 (IO) 维持之前,添加化疗免疫治疗 (ChIO) 的诱导阶段的疗效和安全性.
- 评估12个月无进展生存 (PFS) 的初级终点和包括整体生存 (OS) 和客观反应率 (ORR) 在内的二级终点.
主要方法:
- 一个多中心,单臂,第二阶段试验 (APOLO) 招募了38名患有不可切除IIIA-IIIC期NSCLC的患者.
- 患者接受了3个周期的诱导ChIO (阿特佐利祖马布+卡博普拉丁+帕克利塔塞尔),随后同时接受CT-RT (3个周期),并维持阿特佐利祖马布治疗16个周期.
- 随访时间中位数为29.6个月,数据截止时间为2024年2月.
主要成果:
- 12个月的PFS率为68.4% (95% CI,51.1-80.7),明显超过了55%的零假设.
- 24个月的PFS和OS率分别为50.0%和60.5%. 12个月的生存率为86.8%.
- 在诱导后47.4%的患者中观察到部分反应. 在10名患者中发生了远程进展 (55.6%的进展). 与治疗相关的≥3级不良事件 (TRAEs) 是可以管理的.
结论:
- 诱导化疗-免疫疗法之后CT-RT和IO维护在不可切除的III期NSCLC中表现出显著的活性和可管理的安全性.
- 这些发现支持这种强化治疗策略的潜力,需要在更大的临床试验中对先进的NSCLC进行进一步调查.
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