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治疗晚期食道状细胞癌的第一线sugemalimab与化疗:一项随机的第三期研究

Jin Li¹, Zhendong Chen², Yuxian Bai³

¹Department of Oncology, Shanghai East Hospital, Shanghai, China. lijin@csco.org.cn.

Nature medicine

|February 1, 2024

概括

苏格梅利马布加化疗显著改善了晚期食道状细胞癌 (ESCC) 患者的无进展和整体存活率. 这种组合疗法在3期试验中显示出良好的安全性.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
胃肠道癌症胃肠道癌症

背景情况:

食道状细胞癌 (ESCC) 是全球癌症死亡的重要原因之一.
目前先进的ESCC的第一线治疗方法存在局限性,需要新的治疗策略.
反编程死亡配体1 (anti-PD-L1) 抗体在癌症免疫治疗中是一个有前途的方法.

研究的目的:

评估sugemalimab (一种抗PD-L1抗体) 与化疗相结合的疗效和安全性,作为不可切除,局部发达,复发或转移性ESCC的第一线治疗.
为了比较sugemalimab加化疗和安慰剂加化疗之间的无进展生存率 (PFS),总生存率 (OS) 和客观反应率 (ORR).

主要方法:

一个多中心的,随机的,双盲的第三期试验 (NCT04187352) 招募了540名先前未接受过治疗的ESCC的成年患者.
患者被随机分为2:1接受sugemalimab (1,200毫克) 或安慰剂每3周,长达24个月,并与标准化疗 (cisplatin和5-fluorouracil) 结合,长达6个周期.
有效性终点,包括PFS和OS,通过盲目的独立中央审查进行评估.

主要成果:

与安慰剂加化疗相比,Sugemalimab加化疗显示PFS (中位数6.2个月与5.4个月;HR 0.67;P=0.0002) 和OS (中位数15.3个月与11.5个月;HR 0.70;P=0.0076) 的统计学显著延长.
客观反应率在sugemalimab手臂显著更高 (60.1%对45.2%).
与治疗相关的3级或更高的不良事件的发生率在两组之间相似 (51.3%对48.4%).

结论:

苏格梅利马布加化疗是先进ESCC患者的有效和安全的第一线治疗选择.
这种组合疗法显著改善了关键的生存结果和响应率,而不会增加毒性.
这些发现支持使用sugemalimab与晚期ESCC的化疗结合使用.

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