复旦肿瘤医院薛恺:理性看待PD-1抑制剂 不用过于神化

2018-01-05 薛恺 复旦大学附属肿瘤医院

2015年12月,美国第39届总统吉米·卡特在接受放疗和免疫抗癌新药KEYTRUDA(PD-1抑制剂)治疗后发表声明说,医生在给他做完最近一次脑MRI后,没有发现此前在他大脑中出现的黑色素瘤或新的癌细胞。由此,PD-1抑制剂被民间称为“治愈总统的抗体”,这成功引起了PD-1免疫疗法在全世界范围的广泛关注。

2015年12月,美国第39届总统吉米·卡特在接受放疗和免疫抗癌新药KEYTRUDA(PD-1抑制剂)治疗后发表声明说,医生在给他做完最近一次脑MRI后,没有发现此前在他大脑中出现的黑色素瘤或新的癌细胞。由此,PD-1抑制剂被民间称为“治愈总统的抗体”,这成功引起了PD-1免疫疗法在全世界范围的广泛关注。

PD-1抑制剂治疗的原理是什么?

对于哪些肿瘤患者它的疗效最好?

和化疗、靶向治疗相比,其优势和局限在哪?

如何联合其它治疗进一步提高整体抗肿瘤疗效?

它是万能的治疗神药吗?

带着这些问题,让我们一起走近肿瘤领域的PD-1抑制剂。

PD-1抑制剂的诞生,确实为肿瘤医学的进步带来了巨大的跨越:它实现了横跨多个癌种的突破性进展:部分晚期患者实现了长期生存,可以说在现代抗肿瘤的拉锯战中取得了惊人的成绩,医学研究者们甚至断定:免疫治疗将会是未来攻克癌症的主要方向。PD-1抑制剂真的无往不利吗?我们先来看看它的治疗机理。

一、治疗机理

PD-1(programmed cell death protein 1)程序性死亡受体1,是一种重要的免疫抑制分子。免疫T细胞是人体健康的安全卫士。在人体内,一些小分子常常能与免疫T细胞上的受体结合,抑制它们的活性。这在一般的情况下能够避免安全卫士攻击自己人,避免乌龙事件。但不幸的是,一些肿瘤细胞也会利用这一点,它会很狡猾地产生一种叫做PD-L1的配体,把它当成自己的保护伞,逃过T细胞的攻击。当它与T细胞上的PD-1受体结合后,会抑制T细胞的活性,让它们进入“休眠”状态。

PD-1抑制治疗是通过解除肿瘤细胞逃避免疫系统的新型免疫疗法。PD-1免疫疗法的作用机制是针对PD-1或PD-L1设计特定的蛋白质抗体,阻止PD-1和PD-L1的识别过程,使睡眠中的T细胞唤醒,部分恢复其细胞功能,从而使T细胞可以识别和杀死肿瘤细胞。

简而言之,这类药物阻断了肿瘤细胞对T细胞的“欺骗”,脱掉肿瘤细胞身上的保护伞,让T细胞能够得以保持活性,对肿瘤细胞产生杀伤。

二、适用范围

PD-1抑制剂没有让我们失望:不同于小分子靶向药物的抗癌谱相对较窄,它为癌症治疗带来了多癌种的突破性进展,部分晚期患者因此长期生存,甚至临床治愈。它帮助晚期恶黑患者将5年生存率从17%提高到34%;经过自体干细胞移植和brentuximab vedotin治疗后复发或难治的经典型霍奇金淋巴瘤患者达到了66%的有效缓解。

目前PD-1抑制剂已被以严格闻名于世的美国FDA批准用于近十种肿瘤的治疗,包括:恶黑、非小细胞肺癌、膀胱癌、肾癌、头颈癌、胃癌、肝癌、霍奇金淋巴瘤和MSI-H的实体瘤……

对于PD-1抑制剂起效的疗效预测因子也在不断探索中,期待将来使用该治疗药物时,能更精准地找出相应获益人群。

三、PD-1抑制剂治疗与传统化疗、小分子靶向治疗相比的优势、局限有哪些?

目前,PD-1抑制剂免疫治疗与化疗、小分子靶向治疗是患者及医生同行经常讨论的一个热门话题。当前我们应用的阻断PD-1的免疫检查点抑制剂方法,实际上以解放免疫T细胞,来抵抗肿瘤,在于激发自身的免疫潜能。然而PD-1抑制剂仅对部分患者有效,但它一旦起效,疗效可能持续很长时间。不过也有可能矫枉过正,攻击自身的正常组织。

化学治疗为一种抗增殖治疗,主要杀伤生长活跃的组织细胞,选择性相对较差。因此在杀灭肿瘤细胞同时有可能会杀灭正常组织细胞。

小分子靶向治疗则是改变了化疗的缺点,为一种选择性杀伤,类似于生物学导弹,对于有靶点的患者进行精准治疗,这些靶点都是存在于正常组织,有些靶点甚至先天存在。因此,靶向治疗毒性可能小于化疗,但靶向治疗造成的毒性也不能忽视。

这三种治疗方法各有优缺点。相对来讲,免疫治疗与靶向治疗副作用,一般小于化学治疗副作用。

大家都把PD-1抑制剂称为“抗癌神药”。然而,传统药物治疗仍然大有市场。究其原因PD-1抑制剂存在一个较大的缺陷:有效率低!在临床中,PD-1抑制剂仅对约20%左右的癌症患者有效。

要真正实现治愈肿瘤的目标,当务之急是提高PD-1抑制剂的有效率。所有研究者们都在对这个目标不断奋进。随着研究的深入,免疫联合治疗展现了非常优越的有效性,通过特定的组合,部分肿瘤的控制率达到较好的效果。 举例来说: 2017年6月份召开的美国ASCO年会, PD-1抑制剂Keytruda联合化疗一线用于胃癌的临床数据,令人印象深刻。胃癌:有效率60%,控制率92%。 E7080,又叫乐伐替尼,是一个多靶点的抑制剂,在2017年的欧洲肿瘤学协会年会(ESMO)上, E7080公布了PD-1抗体Keytruda联合E7080针对肾癌的临床数据,一线使用有效率高达83%。 

四、它是万能的治疗神药吗?

其实,各种抗癌新药取得成功并非容易,很多研究项目会因为设计流程、患者选择、毒副反应处理、后续跟踪等多方面原因遭遇失败。

PD-1抑制剂就像一匹从中脱颖而出的黑马。从2014年7月,第一个PD-1抑制剂上市,到现在只有三年余。PD-1抑制剂创造了制药史上的奇迹,陆续获批恶性黑色素瘤、非小细胞肺癌、肾癌、头颈鳞癌、肝癌、胃癌、霍奇金淋巴瘤等适应症,也造福了许多肿瘤患者。但是,作为一个新药,我们还需要更多的研究,才能更好的了解并且驾驭它。就像我们国家自主研制的大飞机、北斗导航、量子通讯,需要3-5年的试飞、测试,形成稳定的操作流程和规范,掌握全面的技术参数和替补措施,才能真正实际应用。此外,疗效方面该药物只是使部分患者受益,还需进一步找出可靠的疗效预测因子; 毒副反应方面,T细胞矫枉过正式的攻击正常组织造成不良反应也不能忽视。

目前,全球已经有多PD-1/PD-L1抗体药物上市,正在进行1600多个临床试验。更加值得我们期待的是,我国多家公司也在研发竞争中脱颖而出,一些相关的临床研究也在国内多个临床医学中心开展。未来这些国产药物的上市,有望缓解新药过于昂贵的难题。可以预见的是,一路上必定是风雨与彩虹相伴,既会有很多波折,也将共同见证很多奇迹。

总之,PD-1抑制剂给我们抗癌治疗带来了新武器、新思路,有望提高肿瘤治疗成功率;但鉴于肿瘤的复杂性、动态变化及对环境的适应性,其治疗仍然有赖于多种技术、策略与经验,应科学而理性地看待它,不用过于神化,并在多学科团队指导下的综合治疗这一根本原则依然不可动摇。

专家简介

薛恺


复旦大学附属肿瘤医院 肿瘤内科 副主任医师

擅长淋巴瘤、头颈部肿瘤等恶性肿瘤的化疗

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    2018-07-18 jklm09
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    2018-01-07 saikp
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    2018-01-07 jyzxjiangqin

    理性看待PD一1抑制剂.

    0

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    2018-01-07 虈亣靌

    学习了.谢谢分享

    0

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    2018-01-06 wqkm

    ^_^^_^^_^^_^^_^

    0

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    2018-01-06 营养医师

    这个已经被神话

    0

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    2018-01-06 飛歌

    不错学习了很有用不错

    0

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