卡博赞提尼布加上伊皮利马布/尼沃马布,用于先前接受过治疗的高级分化甲状腺癌患者
Bhavana Konda1, Eric J Sherman2, Erminia Massarelli3
1Division of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH 43210, USA.
The Journal of clinical endocrinology and metabolism
|August 12, 2024
概括
卡博桑提尼布,尼沃卢马布和伊皮利穆马布在耐火分化甲状腺癌中表现出有限的疗效,反应率低,副作用显著. 这种组合疗法没有达到该研究的疗效目标.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 甲状腺癌研究研究
背景情况:
- 研究人员发起的II期试验评估了先前接受治疗的患者中的卡博桑提尼布,尼沃卢马布和伊皮利穆马布 (CaboNivoIpi).
- 专注于放射性耐火差异化甲状腺癌 (RAI耐火DTC).
研究的目的:
- 评估CaboNivoIpi在RAI耐药DTC患者的疗效,这些患者在之前的VEGFR向治疗中进展.
- 主要终点:在前6个月内客观反应率 (ORR).
主要方法:
- 2周的卡博桑提尼布单一疗法开始,随后是卡博尼沃Ipi的4个周期,然后是卡博桑提尼布加尼沃卢马布.
- 西蒙最优的2阶段设计与中间分析.
- 如果在10名可评估患者中观察到至少5个反应,则研究将进入第二阶段.
主要成果:
- 10%的ORR (1部分响应) 在10名可评估患者中,在6个月内.
- 平均无进展生存时间:9个月;平均整体生存时间:19.2个月.
- 与治疗相关的3/4级 (55%) 和5级 (18%) 副作用的高发病率;高血压是最常见的.
结论:
- 在这个患者群体中,CaboNivoIpi表现出较低的客观应答率.
- 组合疗法与治疗相关的严重 (等级≥3) 副作用的高率有关.
- 该研究没有达到预先规定的疗效值.
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