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在敏感的非小细胞肺癌中,olaparib维持与安慰剂相比:第2期随机 PIPSeN 试验

Sophie Postel-Vinay^1,2,3, Juan Coves⁴, Matthieu Texier⁵

¹Drug Development Department, DITEP, Gustave Roussy, Villejuif, France. sophie.postel-vinay@gustaveroussy.fr.

British journal of cancer

|December 14, 2023

概括

在对敏感的非小细胞肺癌患者中,Olaparib的维持并没有改善无进展生存率或整体生存率. 由于提前终止,PIPSeN研究的动力不足.

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:

敏感性是Poly (ADP-ribose) 聚合酶抑制剂 (PARPi) 在特定癌症类型中的有效性的一个关键生物标志物.
大约三分之一的非小细胞肺癌 (NSCLC) 病例表现出对的敏感性.
在PIPSeN研究中,研究了Olaparib,一个PARPi,作为白金敏感高级NSCLC的维持疗法.

研究的目的:

评估olaparib作为维护疗法的疗效,在患有白金敏感高级NSCLC的患者.
评估无进展生存期 (PFS) 作为主要终点.
作为二次终点,确定整体生存率 (OS) 和安全性.

主要方法:

一个双盲,随机,安慰剂控制的II期临床试验 (PIPSeN,NCT02679963).
纳入标准:未经化疗治疗,ECOG 0-1,对敏感,EGFR/ALK野生型,IIIB-IV期NSCLC.
患者被随机分配到olaparib维持或安慰剂;60名患者被随机分配到计划中的144名患者中.

主要成果:

由于批准了抗PD(L) 1疗法,该研究被提前终止,导致结果不足 (60个随机选择的患者).
中位PFS为2.9个月 (olaparib) 和2.0个月 (安慰剂) (p=0.99).
平均生存期为9.4个月 (olaparib) 与9.5个月 (安慰剂) (p=0.28);没有发现新的安全问题.

结论:

由于早期终止和患者入学率低,PIPSeN试验在统计学上不足.
在这种敏感NSCLC群体中,olaparib维持疗法没有显著改善PFS或OS.
可能需要进一步的研究来确定可以从PARPi维持疗法中受益的患者子组.

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