惠周光教授:PACIFIC研究改写临床实践,Durvalumab续写华章

2019-06-27 佚名 肿瘤资讯

放疗是肺癌非常重要的治疗手段,在不可切除Ⅲ期非小细胞肺癌(NSCLC)的治疗上,根治性同步放化疗是标准治疗,2017年PACIFIC研究的公布,一场“海啸”席卷而来。免疫治疗在晚期NSCLC的治疗上,给部分患者带来了长生存,随着2019年ASCO年会上PACIFIC研究3年随访结果的公布,在不可切除Ⅲ期NSCLC患者中,同样有望获得长期生存。

放疗是肺癌非常重要的治疗手段,在不可切除Ⅲ期非小细胞肺癌NSCLC)的治疗上,根治性同步放化疗是标准治疗,2017年PACIFIC研究的公布,一场“海啸”席卷而来。免疫治疗在晚期NSCLC的治疗上,给部分患者带来了长生存,随着2019年ASCO年会上PACIFIC研究3年随访结果的公布,在不可切除Ⅲ期NSCLC患者中,同样有望获得长期生存。

放射治疗在NSCLC治疗的地位

从Ⅰ期到Ⅳ期NSCLC,放射治疗都是不可或缺的重要治疗手段,占有重要的地位。在Ⅰ期NSCLC中,放疗的进展最引人注目。Ⅰ期NSCLC患者主要分为2类,一类是年龄较大或因严重合并症不能耐受手术或不愿意接受手术的患者,当前立体定向放疗是这部分患者的标准治疗,研究显示,较传统分割放疗,立体定向放疗使治疗疗效得到明显提高,局控率和生存率都提高近1倍。Ⅰ期NSCLC的另一类患者是可手术患者,这类患者放疗和手术治疗是否具有相同的治疗效果仍存在争议,既往研究显示二者疗效类似,而且放疗的毒副作用相对更少,但仍需要大型研究结果支持,目前中美合作的POSTILV/RTOG3502随机研究正在招募患者,相信未来会有更多的研究,给出更多的临床证据。

放疗在NSCLC中应用的第二部分是术后放疗。回顾性研究显示,对于根治性切除术后ⅢA-N2期的患者,在辅助化疗基础上采用直线加速器为基础的适形或调强放疗,可显着改善生存和局控率。目前正在开展前瞻性的Ⅲ期临床试验,研究对于N2期患者,是否应该常规进行术后精准放疗。

Ⅲ期NSCLC是放疗的主阵地,现在的主要标准治疗模式是根治性同步放化疗,再次基础上增加诱导化疗或巩固化疗均未显示临床获益。近期PACIFIC研究证实,ⅢA和ⅢB期不可切除患者在根治性同步放化疗或诱导化疗+根治性同步放化疗基础上给予抗PD-L1抑制剂Durvalumab进行巩固治疗,能够进一步提高总生存时间和无进展生存。基于PACIFIC研究,该治疗方案作为NCCN指南推荐已有1年。

对于晚期NSCLC,既往放疗的目的多是姑息性的,常用于缓解症状,如止血、止痛和缓解呼吸困难等。现在这个观念正在被打破,由于包括免疫治疗和靶向治疗在内的全身治疗的巨大进步,患者生存时间明显延长,此时对部分残存肿瘤或寡转移积极地给予放射治疗,可以显着改善生存,有达到潜在根治的可能。

前面我们提到了PACIFIC研究,国内对PACIFIC研究的解读很多,我个人认为在分析PACIFIC研究时有两点需要注意。首先,PACIFIC研究纳入的ⅢA和ⅢB期患者有限定条件,包括先期治疗完成后疾病没有进展,没有严重的治疗毒副作用,没有大于Ⅱ度的放射性肺炎,因为放疗联合免疫治疗可能加重肺毒性。其次,目前有高级别证据免疫检查点抑制剂只有Durvalumab,其它的抗PD-1/PD-L1药物目前仍缺少充分的证据。

PACIFIC研究3年OS率57%足以改写临床实践

PACIFIC研究最大的意义是打破了近20年来不可切除Ⅲ期NSCLC根治性同步放化疗治疗疗效的瓶颈。为了提高根治性同步放化疗的疗效,既往做了很多尝试,如增加诱导化疗、增加巩固化疗、提高放疗剂量等以改善生存,然而这些传统思维下的治疗尝试,都以失败告终。而PACIFIC研究是在根治性同步放化疗基础上进行了免疫巩固治疗,对无进展生存和总生存时间都有显着提高,这是具有划时代意义的结果,这种治疗模式对医师和患者的影响都将会非常巨大。

2019年ASCO年会上,PACIFIC研究公布根治性同步放化疗后序贯Durvalumab治疗组的3年生存率达到57%,相较于传统根治性同步放化疗30%~40%的生存率,有显着提高,虽非一鸣惊人,但治疗的进步都是一步一个脚印,这也足以改写临床实践。所以PACIFIC研究的3年生存率给了一个很好的提示,可以预测5年长期生存率也会有较大提高,而传统根治性同步放化疗5年生存率只有15%~20%。

放疗联合免疫治疗的思考

放疗如果运用不当,会增加放射性肺炎的发生,免疫治疗也会有免疫性肺炎的发生,二者联合可能会在一定程度上增加肺炎的发生率和严重程度。临床实践中如果采用二者联合治疗,就要从临床获益和毒副作用两个方面进行综合考虑。如果增加一定的毒副作用,但有更巨大的临床获益,那么这种治疗模式是值得的,这和根治性同步放化疗一样,虽然和单纯放疗以及序贯放化疗相比增加毒副作用,但却显着改善了生存,所以根治性同步放化疗替代单纯或序贯放化疗成为标准治疗。

为了更好的保证放疗联合免疫治疗的疗效,减少治疗毒副作用,就要尽量降低每种治疗手段的毒副作用,如从技术层面,可以采用更为先进的放疗技术,如调强放疗、立体定向放疗、质子或重离子放疗,这些放疗技术对肺的影响相对较小,对免疫治疗的不良影响也相对较小。

此外放疗和免疫治疗联合的时机也很重要,如原先认为根治性同步放化疗序贯免疫治疗可能相对安全,但三者同时应用也未必会增加毒副作用,如MD Anderson癌症中心的一项研究初步显示,三种治疗联合毒副作用不但没有增加,肺损伤还有一定程度的降低,近期疗效有明显的增加。所以如何联合能有更大临床获益,如何联合毒副作用相对较低,这些都值得探索。现在相对比较明确的是根治性同步放化疗后预示有≥2级放射性肺炎的患者不宜贸然继续免疫治疗,否则肺损伤可能加重。

放射治疗联合免疫治疗与化疗联合免疫治疗孰优孰劣

我不认为二者具有直接可比性,只要能在现有标准治疗基础上提高疗效,就是更好的治疗。Ⅲ期NSCLC和Ⅳ期NSCLC分别代表不同的人群,Ⅲ期的标准治疗是根治性同步放化疗,放疗作为主导治疗手段并联合免疫治疗,已证实能更好的改善患者生存。Ⅳ期NSCLC以全身治疗为主导手段,化疗和免疫治疗的联合的确也可以改善患者生存,这一点也已得到证实。所以没有孰优孰劣,只要是在标准治疗前提下改善了疗效,就是对不同类型患者更好的治疗选择。

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    2020-04-24 snf701207
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    2020-05-15 bnjfy
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    2019-06-27 yydlt

    恩非常不错,学习了

    0

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    2019-06-27 cqykthl

    免疫治疗在肿瘤中的应用

    0