刘晓晴教授:EGFR敏感突变晚期NSCLC一线治疗进展颇丰,治疗药物选择需综合考虑

2020-03-26 佚名 肿瘤资讯

EGFR敏感突变晚期非小细胞肺癌(NSCLC)的治疗日新月异,新药新组合、新的治疗模式不断改善着患者的总生存时间。

EGFR敏感突变晚期非小细胞肺癌(NSCLC)的治疗日新月异,新药新组合、新的治疗模式不断改善着患者的总生存时间。

2019年EGFR敏感突变晚期NSCLC一线治疗重要研究进展回顾

在2019年,EGFR突变阳性晚期NSCLC的一线治疗有很多临床研究进展,对临床实践产生重大的影响。首先在单药治疗上,有两个研究必须提到,即ARCHER 1050研究和FLAURA研究。

第二代的EGFR TKI达可替尼于2019年5月在国内上市,在2019年ESMO Asia大会上,ARCHER 1050研究更新的OS数据公布,达可替尼组的中位OS达到34.1个月,较吉非替尼组的27.0个月延长了7.1个月(HR=0.748,双侧检验P=0.0155)。在亚洲亚组中,达可替尼组的获益更加明显,中位OS达到37.7个月,较吉非替尼组的29.1个月延长了8.6个月(双侧检验P=0.0457)。此外针对不同EGFR突变类型的患者进行分层分析,在21 L858R突变的患者中,达可替尼组的中位OS达到32.5个月,较吉非替尼组的23.2个月延长了9.3个月(双侧检验P=0.0203)[1]。在整体人群中,几乎所有的分层分析均显示达可替尼组的患者相比吉非替尼组有总生存的获益,达可替尼总生存的延长对于未来的临床实践具有指导性的意义。

既往FLAURA研究的结果显示,相比第一代的吉非替尼/厄洛替尼,第三代的EGFR TKI奥希替尼显着延长患者的PFS,其中位PFS达到18.9个月。在2019年ESMO年会上,FLAURA研究的OS结果终于公布,奥希替尼组的中位OS为38.6个月,虽未达到预期的超过40个月的时间,但其比对照组的31.8个月提高了6.8个月的时间。亚组分析中,奥希替尼相比第一代的吉非替尼/厄洛替尼,并不像上述提到的达可替尼一样,为亚洲患者带来的OS获益[2]。在一线治疗中,达可替尼和奥希替尼所取得的研究数据,尤其是OS方面的结果,对于未来临床实践有很多重要提示,进一步去深究这些数据,对于指导临床治疗具有更重要的意义。

除了单药治疗,EGFR TKI联合治疗同样非常备受关注,包括与化疗或抗血管生成治疗的联合,在2019年,CTONG 1509研究公布,其研究设计与既往日本的Ⅱ期JO25567研究和Ⅲ期NEJ026研究相似,在初治的EGFR敏感突变患者中,头对头比较厄洛替尼联合贝伐珠单抗和厄洛替尼单药的疗效。研究主要终点——独立评审委员会评估的PFS数据显示,相比厄洛替尼单药组,联合治疗组提高了6.7个月(中位PFS:18.0个月 vs 11.3个月)[3]。该研究进一步证明在初治的EGFR敏感突变患者中,“A+T”模式的疗效。

最后,在EGFR TKI联合化疗方面,2019年来自日本的NEJ009研究结果正式在JCO杂志发表,相比吉非替尼单药组,吉非替尼联合化疗组提高了患者的PFS达9.7个月(中位PFS:20.9个月 vs 11.2个月)。同时联合治疗组的中位OS达到50.9个月,而单药组只有38.8个月[4]。上述两项联合治疗研究的结果提示,对于EGFR敏感突变的患者,无论是EGFR TKI与抗血管生成治疗的联合,还是与化疗的联合,相比单纯的EGFR TKI治疗,能够让患者获得更长的PFS,延缓耐药的发生,并且有可能带来更长的OS结果。

EGFR敏感突变晚期NSCLC一线治疗用药选择经验分享

随着2019年达可替尼在中国的上市,目前在EGFR敏感突变晚期NSCLC的一线治疗上已经呈现“三代同堂”的局面,药物选择更多是好事,但同时也给临床医生在治疗选择上带来一些困惑。

在治疗选择时我们首先应该关注药物的疗效,包括近期缓解率、PFS和最重要的OS,其次还需关注药物的安全性、获批的适应证以及药物价格等因素。这当中最重要的一点,因为目前我们所追求的还是尽可能让患者有更长的OS,因此一个药物的PFS再长,其耐药后的治疗对于患者的长期获益同样是非常重要的,因此药物的耐药机制以及耐药后的治疗也是在进行选择时需要考虑的重要因素。

第二方面,如先前分享的2019年的一线治疗最新结果,在ARCHER 1050研究中,达可替尼确实为EGFR敏感突变患者带来非常好的OS获益,提示非常好的治疗前景。基于达可替尼的PFS和OS数据,达可替尼是否能够成为一线治疗首选?“2+3”的模式是否是目前最优的选择呢?鉴于ARCHER 1050研究开展的时间,在一线达可替尼治疗失败后,后续接受第三代TKI治疗的患者比例只有9.7%[5],数据较为有限,但从结果来看,我个人认为“2+3”模式也可能作为EGFR敏感突变患者的首要治疗模式。

第三方面,近年来关于联合治疗的研究越来越多,相比单纯的TKI治疗,TKI联合化疗或抗血管生成治疗有更长的PFS,甚至是OS。随着检测技术的提高以及检测的普及,在初治的部分患者中,其不仅存在EGFR敏感突变,同时还存在耐药基因突变或伴随基因突变,对于这部分患者,联合治疗用于更广阔的治疗前景。当然目前虽然联合治疗有非常好的疗效,但同样我们也需要关注联合治疗的其他问题,首先是联合治疗的安全性,其次是哪些患者最适合联合治疗,选择人群是单纯敏感突变还是共突变患者,或是肿瘤负荷大的患者、难治的患者。此外,联合治疗的时机,是在初始治疗选择联合,还是在分子耐药或临床耐药时再选择联合,我想这些均是值得在未来选择联合治疗时需要考虑的。

EGFR敏感突变晚期NSCLC未来的探索方向

关于EGFR敏感突变晚期NSCLC患者的治疗,未来应该关注以下几个问题。首先,观察2019年公布的相关研究数据,EGFR TKI作为EGFR敏感突变患者的主要治疗选择已经毋庸置疑,但在治疗上应该是越来越精准,对于不同的EGFR基因突变类型,例如敏感突变或非常规突变,甚至是敏感突变中19号外显子缺失突变和21号外显子L858R点突变,从ARCHER 1050研究和FLAURA研究中观察到,这两类患者的获益是不同的,因此未来针对这两类患者,在治疗上是否需要区别对待,还是当做一组人群对待,是未来值得关注的问题。

第二方面是关注耐药的问题,目前虽然在单药基础上进行联合治疗可以进一步延长患者的PFS,延缓耐药的发生,但疗效再好,联合治疗仍然会出现耐药,因此未来在耐药机制方面,单药的耐药机制与联合治疗的耐药机制是否存在差异?针对相应的不同的耐药机制,其对应的处理模式应该会有所不同,只有越来越精准的治疗,以及未来更多的针对不同耐药模式的处理,才能让EGFR敏感突变患者获得越来越长的OS。

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    2020-03-28 liuyiping
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    2020-03-26 肿肿

    NSCLC下一步突破在于新靶点了,靶向治疗和免疫治疗基本见顶了,再有新的就需要新机制了

    0

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