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杜维利西布与多塞塔克塞尔用于患有抗PD-1耐火性,复发性或转移性头支状细胞癌的患者

Glenn J Hanna¹, L B Oakley¹, R Shi²

¹Center for Head and Neck Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.

Clinical cancer research : an official journal of the American Association for Cancer Research

|December 3, 2024

概括

这项研究将PI3K抑制剂与抗PD-1治疗后复发的头癌的多塞塔塞尔结合起来. 该组合显示了19%的应答率,为耐火性HNSCC患者提供了新的治疗选择.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
药理学药理学是指药理学的学科.

背景情况:

抗PD-1治疗后复发的,转移的头部和部状细胞癌 (HNSCC) 具有有限的治疗选择.
抑制PI3K信号传递可能会调节瘤微环境并增加对纳税素的敏感性.

研究的目的:

评估用多塞塔塞尔治疗抗PD-1耐火性HNSCC患者的双PI3Kδ/γ抑制的疗效和安全性.
作为主要终点,评估整体反应率 (ORR).

主要方法:

一个2期试验中,每21天服用杜维利西布 (PI3Kδ/γ抑制剂) 加上多塞塔克塞尔.
这项研究使用西蒙的两阶段设计来评估ORR (RECIST v1.1).
二级终点包括安全性,无进展生存率 (PFS) 和整体生存率 (OS).

主要成果:

总体应答率为19% (5/26名患者),所有患者的反应都是部分反应. 响应的平均持续时间为5.1个月.
46%的患者有稳定的疾病;32%的患者有疾病进展. 中位数PFS为2.8个月,中位数OS为10.2个月.
3级以上与治疗相关的不良事件发生在50%的患者中,主要是肝功能测试的升高. 阴性HPV患者的生存状况有所改善.

结论:

将选择性PI3K抑制剂与多塞塔塞尔结合起来,在抗PD-1耐火性HNSCC中显示出良好的反应率.
这种组合疗法代表了有限选择的患者潜在的新治疗策略.
对免疫学和基因组相关的进一步研究可能会优化治疗选择和结果.

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