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杜尔瓦卢马布与安慰剂与化学放射治疗局部晚期宫癌 (CALLA):一个随机的,双盲的,第三期试验

Bradley J Monk¹, Takafumi Toita², Xiaohua Wu³

¹HonorHealth Research Institute and University of Arizona College of Medicine, Phoenix, AZ, USA.

The Lancet. Oncology

|December 1, 2023

概括

将杜尔瓦卢马布 (PD-L1抗体) 添加到化疗放射治疗并没有显著改善局部晚期宫癌患者的无进展生存率. 在PD-L1表达高的患者中需要进一步的研究.

科学领域:

妇科瘤学妇科瘤学
医学瘤学医学瘤学
免疫治疗是一种免疫疗法.

背景情况:

同时化学放射治疗是局部晚期宫癌的标准,但30-40%的患者会出现复发.
免疫检查点抑制剂对PD-L1阳性转移性或复发性宫癌具有前景.

研究的目的:

评估添加杜尔瓦卢马布 (PD-L1抗体) 与局部晚期宫癌同时进行化学放射治疗的益处.
在这个患者群体中评估无进展生存和安全结果.

主要方法:

在CALLA第三期试验中,随机选择了770名本地晚期宫癌患者接受杜尔瓦卢马布或安慰剂与化疗放射治疗.
化学辐射疗法包括外部光束放射疗法,西斯普拉丁或碳普拉丁,疗法.
主要终点是无进展的生存期,通过研究人员审查进行评估.

主要成果:

在杜尔瓦卢马布或安慰剂组 (HR 0.84;p=0.17) 中均没有达到无进展生存期.
无进展的12个月生存率为durvalumab的76.0%,与安慰剂的73.3%相比.
3-4级不良事件包括贫血和白细胞减少;严重不良事件在杜尔瓦卢马布组略高.

结论:

杜尔瓦卢马布与化学辐射疗法并发的治疗耐受性良好,但在未经选择的人群中没有显著改善无进展生存率.
在患有高瘤PD-L1表达的患者中,需要对杜尔瓦卢马布加化学辐射疗法的进一步研究.

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