JCO || 复发性或持续性卵巢癌:纳武利尤单抗联合伊匹单抗的缓解率高

2021-01-23 太后殿下 张师前公众号

美国纪念斯隆凯特琳癌症中心Zamarin等报告的一项随机Ⅱ期试验显示,对于上皮性卵巢癌(EOC)患者,与单药纳武利尤单抗相比,接受纳武利尤单抗联合伊匹单抗的缓解率更高,无进展生存期(PFS)更长(尽管

美国纪念斯隆凯特琳癌症中心Zamarin等报告的一项随机Ⅱ期试验显示,对于上皮性卵巢癌(EOC)患者,与单药纳武利尤单抗相比,接受纳武利尤单抗联合伊匹单抗的缓解率更高,无进展生存期(PFS)更长(尽管有局限性),且该联合方案的毒性与既往报道的相当。必须进行其他联合研究以确认该双重疗法的持久疗效。(J Clin Oncol. doi: 10.1200/JCO.19.02059.
 
单药PD-1阻断剂在EOC中疗效有限。该研究在患有持续性或复发性EOC 的妇女中,评估了伊匹单抗联合纳武利尤单抗对比单药纳武利尤单抗的疗效。
 
患者入组标准包括:可测量的疾病,1~3种既往治疗方案以及无铂间期(PFI)<12 个月。参与者被随机分配接受静脉给药的纳武利尤单抗(每2周一次)或纳武利尤单抗联合伊匹单抗诱导治4剂(每3周一次),然后每2周一次纳武利尤单抗维持治疗,最多42剂。最初的无效假设是每组随机分配6个月后的客观缓解率相当。
 
100例患者被分配接受纳武利尤单抗(49例)或纳武利尤单抗联合伊匹单抗(51例)治疗,62%的患者PFI <6个月。6个月内,纳武利尤单抗组的6例(12.2%),纳武利尤单抗联合伊匹单抗组的16例(31.4%)患者出现应答(OR=3.28,85% CI 1.54~ ∞,P=0.034)。
 
 纳武利尤单抗组和纳武利尤单抗联合伊匹单抗组的中位PFS分别为2个月和3.9个月,PFI分层的风险比为 0.53(95%CI0.34~0.82);两组的死亡风险比均为0.79(95%CI0.44~1.42)。
 
纳武利尤单抗组有33%的患者,联合组有49%的患者发生≥3级相关不良事件,未发生治疗相关的死亡。在两个治疗组中,PD-L1表达与应答均无显著相关性。

 

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