美国SITC发布,头颈部鳞状细胞癌免疫治疗专家共识

2019-11-10 蓝海贝 肿瘤资讯

美国癌症免疫治疗学会(SITC)于近日发布《头颈部鳞状细胞癌(HNSCC)免疫治疗专家共识》。临床上,提高复发或转移性头颈部鳞状细胞癌(R/M HNSCC)的治疗是一个迫在的亟需。而对于新兴免疫治疗,临床医师尚需要更多的认识,包括精准的患者选择、治疗序列、应答监测、不良事件管理,以及生物标记物检测等。为解决这样的需要,SITC制定此次的专家共识,共识编委包括专家医师、护士、科学家,以及患者权益维护

美国癌症免疫治疗学会(SITC)于近日发布《头颈部鳞状细胞癌(HNSCC)免疫治疗专家共识》。临床上,提高复发或转移性头颈部鳞状细胞癌(R/M HNSCC)的治疗是一个迫在的亟需。而对于新兴免疫治疗,临床医师尚需要更多的认识,包括精准的患者选择、治疗序列、应答监测、不良事件管理,以及生物标记物检测等。为解决这样的需要,SITC制定此次的专家共识,共识编委包括专家医师、护士、科学家,以及患者权益维护者就以上问题基于循证给予规范的临床指导。共识通过8个问题的形式给予推荐,这些指导意见反映免疫治疗应用于HNSCC的最新理念,希望临床医师合理应用而为HNSCC患者达到最大临床获益。

问题一:免疫治疗结合PD-1抑制剂如何应用于复发或转移性HNSCC?

一线治疗:

帕博利珠单抗适用于未接受过治疗的R/M HNSCC。

帕博利珠单抗单药治疗可用于R/M HNSCC以及PD-L1 CPS≥1患者的初始治疗。

帕博利珠单抗单药+化疗(铂类和氟尿嘧啶)可用于治疗未接受过治疗的、生物标志物不明确的R/M HNSCC患者。

二线治疗:

帕博利珠单抗或纳武单抗单药治疗应该应用于铂类难治性R/M HNSCC患者,包括接受铂类为基础化疗方案6个月内进展患者。

问题二:生物标志物检测在HNSCC患者的治疗中起什么作用?

指南委员会建议,不要使用MSI检测标准,即根据IHC染色PD-L1 ≥ 1% TPS或 ≥ 1 CPS为阳性。

当综合阳性评分(CPS)的HNSCC患者接受免疫治疗时,给予生物标记无检测。

问题三:HPV状态如何影响免疫治疗在HNSCC中的应用?

HPV状态(基于p16过度表达)应在治疗计划中,但不应影响为R/M HNSCC患者使用SOC免疫治疗的决策。

问题四:如何评估治疗应答,以及晚期HNSCC如何治疗?

起始治疗后1月内需有首次随访,用于确定免疫相关症状和不良反应(AE)

为继续观察免疫相关症状和AE,至少每月进行一次评估,如果患者不良反应剧烈需增加评估频次

首次随访后,应每3月进行一次患者评估(通过放射成像)以监测患者的应答迹象

经过治疗并接受6个月免疫治疗的维持治疗后,如果CR或者接近CR,则继续治疗至少2年或者治疗直到疾病进展或出现毒性反应

针对初次评估,请通过CT或PET-CT扫描技术为患者做一次基线检查

如果患者出现症状进展/临床恶化,停止治疗

如果在治疗早期观察到放射学进展,并且患者临床情况稳定,继续治疗第二次扫描确定病情恶化

如果在PD-1抑制剂治疗时或治疗后疾病进展:患者入组临床试验,请使用姑息放疗和/或化疗(紫杉烷)

问题五:应如何识别和处理HNSCC患者的免疫相关不良事件?

针对irAE < 3级,对于1级不良事件继续ICIs(某些神经、血液或心脏毒性事件除外);对于2级不良事件,停止IO治疗并密切监测门诊治疗情况(包括考虑使用口服类固醇激素)

针对irAE ≥ 3级,停止治疗,允许患者入院并服用类固醇激素

通过影像学检查和AST/ALT水平对甲状腺功能、颈部和气道行常规监测

对于甲状腺功能减退的患者,继续免疫治疗,给予左甲状腺素治疗,并每两月一次行甲状腺评估

如果发生巨快病变导致功能或器官损害:停止治疗

相比其他癌种而言,肺炎事件对于HNSCC接受免疫治疗患者不是太严重的问题

问题六:HNSCC患者中哪些患者不应该接受免疫治疗

不要根据年龄、肺癌转移、合并症,及自身免疫疾病等情况自行认为患者不适于抗PD-1单抗免疫治疗

患有丙型肝炎或者HIV+等免疫控制疾病的患者,CD4+ T细胞计数正常且正在接受抗逆转录病毒治疗,通常适合ICI治疗

问题七:免疫疗法在头颈癌罕见亚型的治疗中起什么作用?

对于转移性或局部晚期cSCC不适合行根治性手术或放疗患者,应使用cemiplimab

鼻咽癌患者不同于其他HNSCC患者。复发或转移性疾病患者建议入组临床试验(首要治疗选择);若患者无条件入组临床试验,铂类难治性鼻咽癌患者可以从PD-1/PD-L1单药治疗获益

问题八:如何在HNSCC患者的新型系统性联合治疗策略中结合免疫疗法?

出于提高患者应答率的考虑,所有共识编委中的临床工作者达成一致意见,对于疾病迅速进展患者推荐联合治疗(特别是:化疗+IO)。

从指南推荐来看,如何评估免疫应答,和如何处理免疫相关不良反应是临床最为关切的问题。

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    2019-11-12 wshxjq
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