来自一项Ibrutinib组合疗法在晚期尿癌中进行的第1b/2期研究的结果
Nataliya Mar1, Yousef Zakharia2, Alejandro Falcon3
1Division of Hematology/Oncology, University of California Irvine, Orange, CA 92868, USA.
Cancers
|June 10, 2023
概括
布鲁顿的氨酸激酶抑制剂易布鲁替尼 (ibrutinib) 在晚期泌尿腺癌 (UC) 中表现有前途. 与布罗利祖马布或帕克利塔克塞尔的联合治疗表明,与单一药物的历史数据相比,反应率有所改善.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 尿癌研究 尿癌研究
背景情况:
- 易布鲁替尼是B细胞恶性瘤的经批准的布鲁顿氨酸激酶抑制剂.
- 晚期泌尿腺癌 (UC) 仍然是一个具有挑战性的疾病,治疗选择有限.
研究的目的:
- 评估单独或组合使用易布鲁替尼的安全性和有效性,用于晚期泌尿腺癌 (UC).
- 在UC患者中确定ibrutinib的推第二阶段剂量 (RP2D).
主要方法:
- 第1b/2期临床试验设计.
- 易布鲁替尼口服 (840毫克或560毫克每天) 作为单一药物或与帕克利塔塞尔或潘布罗利祖马布结合使用.
- 评估无进展生存率 (PFS),整体反应率 (ORR) 和安全概况.
主要成果:
- 单剂伊布鲁丁尼布显示了7%的ORR. 易布鲁替尼加布罗利祖马布可以达到36%的ORR.
- 易布鲁替尼加帕克利塔塞尔的ORR为26%,PFS中位数为4.1个月.
- 安全性概况与单个药物的已知副作用一致.
结论:
- 易布鲁替尼组合,特别是与班布罗利祖马布组合,表明在以前接受过治疗的UC患者中疗效提高.
- 对ibrutinib组合的观察到的ORR超过了单剂疗法的历史基准.
- 需要对尿路细胞癌中的基于易布鲁替尼的治疗方案进行进一步的研究.
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