Lancet Oncol:纳武单抗或可成为一线治疗后进展的恶性间皮瘤的新选择!

2021-10-19 Nebula MedSci原创

纳武单抗代表了一种可能对一线治疗后进展的恶性间皮瘤患者有益的治疗方法

迄今为止,尚无 3 期试验显示,哪种药物可提高铂类化疗后进展的胸膜或腹膜恶性间皮瘤患者的生存率。本研究是一项在英国的24家医院开展的多中心、安慰剂为对照、双盲、平行组、随机的3期试验,旨在评估抗PD-1抗体纳武单抗在这类患者中的疗效和安全性

招募了年满18岁的既往接受过以铂类为基础的一线化疗的、影像证据提示疾病进展的、ECOG表现状态0或1分、组织学确诊的胸膜或腹膜间皮瘤患者,随机(2:1)分成两组,接受纳武单抗(240 mg/2周,固定剂量,静滴)或安慰剂,直到疾病进展或满12个月。主要终点是无进展生存期和总生存期。

两组的无进展生存期和总生存期

2017年5月10日至2020年3月30日,共招募了332位患者,其中221位(67%)被随机分至纳武单抗组,111位(33%)被分至安慰剂组。中位随访了11.6个月。纳武单抗组和安慰剂组的中位无进展生存期分别是3.0个月和1.8个月(校正风险比[HR] 0.67, 95% CI 0.53-0.85; p=0.0012)。纳武单抗组和安慰剂组的中位总生存期分别是10.2个月和6.9个月(校正HR 0.69, 95% CI 0.52-0.91; p=0.0090)。

部分副反应事件的发生情况

最常见的3级及以上的治疗相关的副反应有腹泻(纳武单抗组 vs 安慰剂组:3% vs 2%)和输液相关反应(3% vs 0)。纳武单抗组有90位(41%)、安慰剂组有49位(44%)患者发生了严重副反应。两组均无治疗相关死亡病例。

综上所述,纳武单抗代表了一种可能对一线治疗后进展的恶性间皮瘤患者有益的治疗方法

原始出处:

Dean A Fennell, et al. Nivolumab versus placebo in patients with relapsed malignant mesothelioma (CONFIRM): a multicentre, double-blind, randomised, phase 3 trial. The Lancet Oncology. October 14, 2021. https://doi.org/10.1016/S1470-2045(21)00471-X

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    2022-07-29 minlingfeng
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    2021-12-24 howi
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    2021-10-20 JZ Yang

    感谢分享

    0

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    2021-10-20 595690844

    !!!

    0

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