在高级细胞癌中对无治疗生存的综合分析
Elaine Chang1, Jiaxi Zhou2, Chi Song1
1Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
概括
在接受免疫瘤学 (IO) 和氨酸激酶抑制剂 (TKI) 组合的高级细胞癌 (aRCC) 患者中,无治疗生存期 (TFS) 与单独的TKI相似. 这包括没有显著毒性的TFS,这表明在这个特定的环境中没有额外的好处.
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:
- 在无治疗间隔期间持久的临床益处是免疫瘤学 (IO) 疗程的关键目标.
- 具有和没有毒性的无治疗生存 (TFS) 的特征对于评估IO-VEGF氨酸激酶抑制剂 (TKI) 组合至关重要.
研究的目的:
- 在先进细胞癌 (aRCC) 患者中,以前线IO-VEGF TKI组合治疗与单独使用TKI治疗的患者中,描述无治疗生存期 (TFS).
- 在这个患者群体中评估TFS与或没有持续的毒性.
主要方法:
- 进行了对来自随机试验的个人患者数据的综合分析,评估前线IO-TKI组合在治疗前的aRCC中.
- 无治疗生存期 (TFS) 估计使用30个月的受限平均时间,以协议治疗停止的时间和随后的全身治疗开始或死亡的时间来定义.
- 评估了具有和没有毒性的整体存活率 (OS),TFS和TFS.
主要成果:
- 在IO-TKI组中的1,183名患者和在sunitinib (SUN) 组中的1,184名患者的三个试验符合标准.
- 平均TFS为IO-TKI的2.7个月和SUN的2.9个月,分别占30个月期间的9%和10%.
- 没有3级以上毒性的平均TFS为IO-TKI的1.7个月和SUN的2.3个月.
结论:
- 在此后期分析中,IO-TKI和SUN组的无治疗生存率 (TFS) 和无毒性TFS似乎相似.
- 这些发现可能会受到协议设计的影响,包括TKI延续到进展和IO停止2年后在一些试验中.
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