Nature Medicine:结直肠癌患者要不要接种COVID-19疫苗

2021-05-28 MedSci原创 MedSci原创

癌症患者避免在试验性治疗后48-72小时内接种疫苗,但COVID-19疫苗接种的利益-风险状况仍然强烈支持在这一人群中接种疫苗。在疫苗推出期间优先考虑癌症患者是至关重要的。

细胞因子释放综合征(CRS)/细胞因子风暴是一种全身炎症反应,其特征是细胞因子释放过度(即INF-γ、IL-6、IL-10和IL-2R升高)。CRS可能发生在感染后(包括COVID-19)或由于医源性原因,最显著的是嵌合抗原受体T细胞(CAR-T)治疗,较少的情况下,是细胞毒性化疗或干细胞移植。极其罕见的是,它发生在免疫检查点抑制剂(ICI)治疗后,而且据我们所知,没有在使用任何疫苗后发生的报道。

Lewis Au等报告一例COVID-19 mRNA疫苗BNT162b2 (tozinameran)接种后发生CRS的病例。

目前,全球范围内将癌症患者列为COVID-19疫苗接种计划的优先对象,其中包括mRNA疫苗的管理细胞因子释放综合征(CRS)尚未在mRNA疫苗中报道,它是一种极其罕见的免疫检查点抑制剂的免疫相关不良事件。Lewis Au等报告了一例长期抗PD-1单药治疗的结直肠癌患者接种BTN162b2 (tozinameran)( Pfizer-BioNTech mRNA COVID-19疫苗)后5天发生CRS的病例。

2019年2月,一名58岁男性开始抗PD-1单药治疗(一项正在进行的介入临床试验中的实验性ICI;NCT02715284),用于转移至肠系膜和腹直肌的错配修复缺陷结直肠癌(MMRd CRC)的治疗(图1a)。在治疗开始两个月后,该患者经历了神经免疫相关不良事件(irAE),并在病因不明的脊髓小脑共济失调的背景下恶化(1至2级,脑桥、髓质和小脑的磁共振成像改变)。ICI被暂停,开始使用1 mg kg−1泼尼松龙(1个月后逐渐减少),共济失调恢复到1级(基线)。

于2019年6月重新开始抗PD-1治疗 ,根据实体肿瘤免疫相关应答评估标准,病情稳定。

2020年3月(开始ICI后13个月),患者出现内分泌类irAE(1级促肾上腺皮质激素缺乏引起的低皮质醇血症;图1a),并开始使用生理皮质类固醇替代(泼尼松龙,每天3毫克)。疾病得以控制,最后一剂ICI于2020年12月执行,即接种BNT162b2前27天。

该患者从癌症诊断到CRS炎症标志物的临床过程

患者无SARS-CoV-2感染史,于2020年6月和10月SARS-CoV-2血清学检测阴性。2020年12月29日,接受了第一剂BNT162b2疫苗(图1a),除接种部位1级炎症外,没有立即发生不良事件。5天后(最后一次抗PD-1剂量后32天),尽管使用了退烧治疗(布洛芬),患者仍出现肌痛、腹泻2天(1级)和发热1天(38.4°C)。入院时,生命体征如下:氧饱和度,100%室内空气;呼吸频率,每分钟18次呼吸;血压111/71 mmHg;心率每分钟86次;温度为36.7℃。实验室检查发现炎症标志物(c反应蛋白(CRP))升高,125 mg L−1;血清乳酸脱氢酶(LDH), 184 U L−1;血小板减少(68 × 109个细胞每升;开展静脉注射广谱抗生素的经验性治疗;然而,血液和尿液培养均为阴性,SARS-CoV-2 RT-PCR序列鼻咽拭子也为阴性。在入院或随访期间没有任何临床体征或症状怀疑该患者有血栓事件。胸部、腹部及骨盆CT未见感染或血栓形成,且显示疾病相对于癌症稳定。病人没有肝素化。在接下来的5天里,持续39.8°C的发烧,血小板减少症恶化(每升28 × 109个细胞)和炎症标志物增加(CRP, 317 mg L−1;LDH, 849 U L−1),包括显著升高的铁蛋白(6010µg L−1(正常范围,18-464µg L−1)。此时(入院后5天),怀疑为CRS(3级),开始静脉注射甲基泼尼松龙(IVMP) 1mg kg - 1, 3 d后停用抗生素。IVMP开始后7天内,生化和血液学指标均恢复正常,患者停用皮质类固醇治疗出院后,无发热,无症状。于2021年2月8日(首次就诊36天后)再次接受抗PD-1治疗,无任何不良事件发生。该患者未接种第二剂BNT162b2疫苗。

BNT162b2疫苗的细胞因子谱及免疫应答

炎症标志物升高、血小板减少、细胞因子水平升高(IFN-γ/ IL-2R / IL-18 / IL-16 / IL-10)和类固醇反应证明了CRS。

在这种情况下,疫苗接种与CRS的诊断在时间上紧密相关,这表明CRS是疫苗相关的不良事件。抗PD-1阻断剂是潜在的贡献因素。总体而言,癌症患者还需要进一步的前瞻性药物警戒性数据,但是受益风险曲线仍然强烈支持在这一人群中接种COVID-19疫苗。

鉴于癌症患者被排除在SARS-CoV-2疫苗研究之外,且目前在全球COVID-19疫苗接种项目中处于优先地位,该病例促使人们对COVID-19疫苗在癌症患者中的安全性进行前瞻性药物警戒。到目前为止,前瞻性数据尚未证明BNT162b2在一般癌症患者(n = 151)或接受ICI治疗的患者(n = 170)中具有额外的安全性。

目前关于COVID-19疫苗接种时机的实证建议是,对癌症患者进行“可获得性”的全身抗癌治疗,包括ICI、细胞毒性化疗和激素治疗,避免在试验性治疗后48-72小时内接种疫苗,以减少不良事件原因的错误归因。

总体而言,由于本病例的CRS是一个个案报告,癌症患者通常更容易感染COVID-19,COVID-19疫苗接种的利益-风险状况仍然强烈支持在这一人群中接种疫苗。在疫苗推出期间优先考虑癌症患者是至关重要的。

原文出处

Au, L., Fendler, A., Shepherd, S.T.C. et al. Cytokine release syndrome in a patient with colorectal cancer after vaccination with BNT162b2. Nat Med (2021). https://doi.org/10.1038/s41591-021-01387-6

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    2021-09-02 liye789132251
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    2021-06-26 kalseyzl
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    2021-07-31 jeanqiuqiu
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    2021-05-28 骨科实习生

    这真是难得的牛

    0

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