SCIENCE:粪便微生物群移植可能有助于消除黑色素瘤患者对免疫治疗的耐药性

2021-06-09 网络 网络

FMT可能有助于对晚期黑色素瘤患者的肠道微生物群进行重新编程,这可能中和对抗PD-1免疫治疗耐药性。

两项1期临床研究表明,在一些在抗程序性细胞死亡蛋白1(抗PD-1)药物治疗期间持续或进展的转移性黑色素瘤患者中,粪便微生物群移植(FMT)可能恢复对抗PD-1抑制的敏感性。需要进一步的研究来更好地识别微生物、循环和肿瘤内的生物标志物,以便选择最有可能从基于粪便微生物组的黑色素瘤治疗中获益的患者。

最近发表在SCIENCE杂志的两篇文章报道称,FMT可能有助于对晚期黑色素瘤患者的肠道微生物群进行重新编程,这可能中和对抗PD-1免疫治疗耐药性。

一些观察性研究表明,转移性黑色素瘤患者的肠道微生物群与他们对免疫检查点抑制剂(CPI)治疗的反应之间存在关联。虽然在临床前小鼠模型中,肠道微生物群也可以影响肿瘤对抗PD-1免疫治疗的反应,但尚未在抗PD-1免疫治疗后黑色素瘤持续或进展的人类患者的临床试验中进行FMT研究。

其中一项研究包括来自宾夕法尼亚州匹兹堡市匹兹堡大学希尔曼医学中心(UPMC)医学系和马里兰州贝塞斯达国立卫生研究院临床中心的7名FMT捐赠者和15名接受者。第二项试验包括2名FMT捐赠者和10名来自以色列Tel-HaShomer Sheba医疗中心Ella Lemelbaum免疫肿瘤研究所的受者。所有FMT捐赠者都是对抗PD-1免疫治疗有反应的转移性黑色素瘤患者。以色列两组均有完全反应(CR),匹兹堡组有4组有完全反应,3组有部分反应(PR);研究人员假设,他们的肠道微生物群是这些有利结果的一个因素,因此,可能有利于对类似治疗产生耐药性的患者。

两项研究中的FMT方案都包括了初始的原生微生物群落消耗方案,其中包括万古霉素和新霉素。然后患者进行结肠镜FMT和口服粪便胶囊,随后再次诱导纳武单抗抗PD-1治疗(在以色列的研究中),或仅通过结肠镜FMT,随后进行派姆单抗(在匹兹堡的研究中)。

匹兹堡研究中的15名FMT受者的结果包括3名PR患者和3名病情稳定患者。以色列研究中的10个FMT接受者也发现了类似的结果:1个CR和2个PRs。两个研究小组的结论是,他们的发现表明FMT是安全的,改变肠道微生物群中的细菌组合可以提高免疫治疗在一部分患者中的疗效。

这项研究证明可以通过重新编程肿瘤微环境来操纵微生物组来增强和提高晚期黑色素瘤的免疫治疗效果,并克服抗PD-1的耐药性

Zarour博士和他的团队还发现, 一些PD-1难治性患者可能对FMT没有反应,原因可能包括患者的免疫缺陷状态或可能因为缺乏肿瘤免疫原性而对肿瘤无反应,无论微生物群组成如何。FMT制剂中可能缺少抗PD-1治疗效果所需要的细菌分类群,或者可能“FMT无法成功植入受体,也无法诱导有利于抗PD-1的宿主微生物群的扰动。”

在以色列的研究中,研究人员观察了3名患者的临床反应,包括2名PRs和1名CR。除了观察临床抗肿瘤反应,两个团队进行了广泛的分子检测,支持FMT改变一些患者肠道微生物组的假设,这影响了他们肠道相关免疫细胞和肿瘤浸润免疫细胞的组成。值得注意的是,FMT治疗与肠道固有层和肿瘤微环境中的免疫细胞浸润和基因表达谱的良好变化相关

根据这两项研究,FMT对CPI治疗患者可能有治疗效果。然而,要使这种疗法获得批准,还需要解决一些临床、监管和科学方面的问题。此外,需要在明确的CPI后人群中进行更大规模的研究来证明FMT的有效性。

目前,由于微生物群调节的复杂性和操作不当带来的相关风险,微生物群调节应继续在临床试验的高度监测环境中进行。这两项研究只提供了一个原则证明,不能夸大数据,因为15个病人中只有6个有良好的结果。还需要进一步的研究来更好地识别微生物、循环和肿瘤内生物标志物,以便选择最有可能从基于微生物组的黑色素瘤治疗中获益的患者。未来的工作需要更好地了解供体FMT的来源、移植程序和受体表型是成功的CPI-FMT联合治疗所需要的反应特性。

原文出处

1、 Fecal microbiota transplant promotes response in immunotherapy-refractory melanoma patients. BY EREZ N. BARUCH, SCIENCE05 FEB 2021 : 602-609. 

2、 Fecal microbiota transplant overcomes resistance to anti–PD-1 therapy in melanoma patients. BY DIWAKAR DAVAR, SCIENCE05 FEB 2021 : 595-602

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    2022-03-06 sunylz
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    2021-06-11 jichang
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    2021-06-11 Homburg
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    2021-06-09 124d63dfm42暂无昵称

    学习了

    0

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复宏汉霖宣布与润新生物就BRAF V600E抑制剂RX208达成一项独家许可合作,复宏汉霖获得该产品在中国(包括中国香港、中国澳门和中国台湾)进行研究、开发、生产和商业化等的独家权利。