Lancet Oncol:派姆单抗单药治疗BCG-无应答性高危型非肌肉浸润性膀胱癌的疗效

2021-05-27 Nebula MedSci原创

派姆单抗单药治疗BCG-无应答性非肌肉浸润性膀胱癌的抗肿瘤活性较高,或可成为这类难以治疗的人群的非手术治疗方案

高危型非肌肉浸润性膀胱癌的标准治疗方法是经尿道膀胱肿瘤切除术,继以膀胱内BCG免疫治疗。但是,尽管治疗初期的缓解率很高,但仍有高达50%的患者可能会复发或对BCG耐受。PD-1信号通路激活与BCG耐药有关。

KEYNOTE-057研究评估了PD-1抑制剂派姆单抗用于BCG-无应答性非肌肉浸润性膀胱癌的疗效和安全性。

这是一项在14个国家的54个医疗中心开展的开放标签、单臂、多中心的2期研究。A队列招募了年满18岁的组织学确诊的有或无乳头状瘤的BCG-无应答性原位膀胱癌患者,且不适合或拒绝行根治性膀胱切除术。所有患者都接受派姆单抗(200 mg/3周)治疗,直到满24周或出现病程进展、复发、耐药、不可接受的毒性,或撤出试验。主要终点是第1剂研究药物后3个月的临床完全缓解率。

2015年12月9日-2018年4月1日,共筛查了334位患者,其中186位不符合纳入条件,47位患者被分至B队列(BCG-无应答性高Ta期或无原位癌的任何T1期的乳头状瘤;结果不包含在本次分析中)。A队列的101位患者至少接受了一剂派姆单抗治疗,被纳入安全性分析。5位患者不符合FDA对BCG-无应答性非肌肉浸润性膀胱癌的定义,被排除疗效分析(n=96)。

首剂派姆单抗后的应答持续时间

中位随访了36.4个月(IQR 32.0-40.7)。96例BCG-无应答性伴或不伴乳头状瘤的膀胱原位癌患者中有39位(41%,95%CI 30.7-51.1)在3个月时获得完全缓解

治疗相关不良反应

13位(13%)患者发生了最常见的3/4期治疗相关的不良反应;最常见的有关节痛(2%)和低钠血症(3%)。8位(8%)患者发生了严重的治疗相关的不良反应。无治疗相关死亡病例。

综上所述,派姆单抗单药治疗BCG-无应答性非肌肉浸润性膀胱癌的耐受性良好,而且显示出了令人期待的抗肿瘤活性,或可成为这类难以治疗的人群的非手术治疗方案

原始出处:

Arjun V Balar, et al. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study. The Lancet Oncology. May 25, 2021. https://doi.org/10.1016/S1470-2045(21)00147-9

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    2022-01-11 howi
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    2022-03-07 minlingfeng
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    2021-05-28 148aa5c4m83(暂无昵称)

    学习了,谢谢分享

    0

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    2021-05-28 仔仔斧

    学习了

    0

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    2021-05-28 健康达人

    肿瘤免疫是大家关心的话题,K药与其它药对比,值得关注!

    0

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    2021-05-28 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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    2021-05-28 goodbing

    顶刊就是不一样,质量很高,内容精彩!学到很多

    0

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Eur Radiol:如何识别膀胱癌的肌层浸润深度?

膀胱癌有无肌层浸润决定了治疗方案的选择和预后。经尿道膀胱肿瘤切除术对无肌层浸润性膀胱癌的首选治疗手段,根治性膀胱切除术是肌层浸润性膀胱癌的标准治疗方法。

Eur Urol:铂治疗的局部晚期或转移性尿路上皮癌患者的Atezolizumab与化疗治疗比较

Atezolizumab是一种抗PD-L1免疫检查点抑制剂,推荐用于治疗先前含铂化疗后的局部晚期或转移性尿路上皮癌(mUC)。

Eur Urol Oncol:肾癌和膀胱癌中无细胞和循环肿瘤DNA的临床应用

膀胱癌和肾癌需要侵入性方法进行明确诊断,而膀胱癌需要重复侵入来监测疾病的复发。鉴于最近在液体活检中利用分子改变来诊断和监测疾病,有必要对越来越多的证据进行综合分析。

Eur Urol Focus:基于人工智能的常规组织学检测膀胱癌FGFR3突变状态

成纤维细胞生长因子受体(FGFR)抑制剂治疗已成为膀胱癌中第一个获得临床批准的靶向疗法。然而,该疗法需要事先对每为患者进行分子测试,昂贵且不是普遍可用的。