贝尔佐瑟蒂布加托波特干与托波特干单独治疗复发小细胞肺癌患者:一项随机临床试验
Nobuyuki Takahashi1,2, Zhonglin Hao3, Liza C Villaruz4
1National Cancer Institute, Center for Cancer Research, Bethesda, Maryland.
JAMA oncology
|October 12, 2023
概括
在复发的小细胞肺癌 (SCLC) 中,添加贝佐谢蒂布 (berzosertib) 给托波特坎并没有改善无进展的生存率. 然而,这种组合治疗显著改善了SCLC患者的整体存活率.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 药理学 药理学是指药理学的学科.
背景情况:
- 小细胞肺癌 (SCLC) 是一种具有侵略性的癌症,对于复发病例的治疗选择有限.
- 复制应激是SCLC的一个关键特征,表明潜在的治疗点,如ATR激酶.
- 作为ATR激酶抑制剂的伯佐瑟蒂布在SCLC的临床前研究中显示出有前途.
研究的目的:
- 评估在复发性SCLC患者中结合贝尔佐瑟蒂布和托波特坎的疗效和安全性.
- 为了确定这种组合是否改善无进展生存 (PFS) 和整体生存 (OS) 与单独托波特干相比.
主要方法:
- 一个开放的,第二阶段随机临床试验与60名复发性SCLC患者进行.
- 患者被随机分配,接受单独的托波特坎或托波特坎加贝尔佐塞尔蒂布.
- 主要终点是PFS,OS作为一个关键的次要终点. 使用Kaplan-Meier和Cox比例危险模型分析了生存结果.
主要成果:
- 在组合手臂和单独托波特坎之间没有观察到PFS的显著差异 (PFS中位数:3.9vs3.0个月;HR,0.80;P=.44).
- 在接受贝佐瑟蒂布加托波特干组的整体存活时间明显更长 (中位数OS:8.9 vs 5.4个月;HR,0.53;P=.03).
- 两个治疗组的不良事件概况是可比的,血小板缺血和恶心的发病率相似.
结论:
- 在复发性SCLC患者中,添加贝尔佐瑟蒂布到托波特坎并没有改善PFS.
- 柏佐瑟蒂布和托波特坎的组合表明,整体存活率显著改善.
- 这表明ATR抑制在复发性SCLC的化疗组合中可能发挥作用,需要进一步调查.
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