研究结果:
替雷利珠单抗联合化疗组和安慰剂联合化疗组患者中位OS时间分别为15.5个月和13.5个月(HR=0.75,P=0.003 5),中位PFS时间分别为4.8个月和4.3个月(HR=0.63,P<0.0001),中位缓解持续时间(duration of response,DOR)分别为4.3个月和3.7个月。值得注意的是,真实世界中有15%~20% SCLC患者初诊时已发生脑转移,该研究虽预设了脑转移分层,但试验组仅有1例脑转移患者;亚组分析中无脑转移患者数据,缺乏对脑转移ES-SCLC疗效参考价值。
该研究再次证实除了程序性细胞死亡配体1(programmed cell death ligand 1,PD-L1)单抗之外,PD-1单抗联合化疗可以提高ES-SCLC预后。结合既往研究结果可以看出:免疫治疗联合化疗已经可以将ES-SCLC中位OS时间延长至15个月。
替雷利珠单抗+化疗与单纯化疗相比显著改善患者生存,中位OS分别为15.5个月 vs 13.5个月(HR=0.75;95%CI:0.61-0.92;P=0.0035),2年OS率分别为33.2%和22.4%,3年OS率分别为25%和9.3%(2023 WCLC摘要#OA01.06)。
生存数据
来源:
CHENG Y, FAN Y, ZHAO Y, et al. First-line chemotherapy with or without tislelizumab for extensive-stage small cell lung cancer:RATIONALE-312 phase 3 study[J]. J Thorac Oncol, 2023,18(Suppl 11):S46.
参考文献:
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