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杜尔瓦卢马布加帕佐帕尼布组合治疗晚期软组织瘤患者:一项II期试验
Hee Jin Cho1, Kum-Hee Yun2, Su-Jin Shin3
1Department of Biomedical Convergence Science and Technology, CMRI, Kyungpook National University, Daegu, Republic of Korea.
Nature communications
|January 23, 2024
概括
帕佐帕尼布和杜尔瓦卢马布的联合治疗显示,转移性软组织肉瘤 (STS) 的整体应答率为30.4%. 在这项癌症治疗研究中,高CD20+B细胞透预测了更长的无进展生存期.
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:
- 转移性和/或复发性软组织肉瘤 (STS) 仍然是一个具有挑战性的临床问题,有效的治疗选择有限.
- VEGF受体氨酸激酶抑制剂和PD-L1抑制剂正在成为各种癌症的有前途的治疗药物.
研究的目的:
- 评估在患有转移性/复发性STS的患者中,将帕佐帕尼布 (抗VEGF受体激素激酶抑制剂) 与杜尔瓦卢马布 (抗PD-L1抑制剂) 结合使用的疗效和安全性.
- 为了确定潜在的生物标志物,预测治疗反应.
主要方法:
- 一个单臂,第二阶段临床试验 (NCT03798106) 进行.
- 患者每天接受一次帕佐帕尼布800毫克,每3周服用杜尔瓦卢马布1500毫克.
- 主要终点是整体应答率 (ORR);次要终点包括无进展生存率 (PFS) 和安全性.
主要成果:
- 该研究达到其主要终点,达到ORR30.4%.
- 中位数PFS为7.7个月. 常见的3-4级不良事件包括中性质减退,肝酶升高和血小板减小.
- 转录基因分析显示,B谱系的特征是反应的关键决定因素 (P=0.014).
- 高CD20+B细胞透率和血管密度与更长的PFS (P=6.5 × 10-4) 和更好的反应率 (50%对12%,P=0.019) 相相关.
- 在多变量分析中,CD20+ B细胞透是PFS的唯一独立预测因子.
结论:
- 杜尔瓦卢马布和帕佐帕尼布的组合在未经选择的STS患者队列中显示出有希望的疗效.
- 治疗方案表现出可管理的毒性概况.
- CD20+ B细胞透是接受这种联合治疗的STS患者治疗反应和生存的重要预测生物标志物.
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