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严重急性呼吸综合征冠状病毒2型(SARS-CoV-2)疫苗在伴有或不伴有活动性或既往自身免疫性疾病的胸腺瘤患者中的应用:TYME网络安全性分析简要报告

SARS-CoV-2 vaccine in patients with thymic epithelial tumours with and without active or pre-existing autoimmune disorders: Brief report of a TYME network safety analysis.

作者信息

Giugliano Federica, Zucali Paolo A, Galli Giulia, Ballatore Zelmira, Corti Chiara, Aliaga Pamela T, Uliano Jacopo, Vivanet Grazia, Curigliano Giuseppe, Conforti Fabio, Queirolo Paola, Berardi Rossana, Manglaviti Sara, Apollonio Giulia, Perrino Matteo, Borea Federica, D'Antonio Federica, Garassino Marina C, De Pas Tommaso

机构信息

Division of New Drugs and Early Drug Development for Innovative Therapies, European Institute of Oncology, IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.

Department of Oncology, IRCCS, Humanitas Clinical and Research Center, Via Manzoni 56, 20089, Rozzano, Milan, Italy; Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, 20090, Pieve Emanuele, Milan, Italy.

出版信息

Eur J Cancer. 2022 May;166:202-207. doi: 10.1016/j.ejca.2022.02.011. Epub 2022 Feb 25.

Abstract

BACKGROUND

International guidelines recommend severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine for patients with cancer. A substantial risk of developing vaccine-related autoimmune toxicities could be hypothesised for patients with thymic epithelial tumours (TETs) due to their high risk of autoimmune disorders (ADs). Moreover, a cross-reaction between SARS-CoV-2 spike protein antibodies and various tissue proteins has been shown, and antibodies against nucleoproteins showed overlaps in the autoimmune cross-reaction with antibodies to spike protein. Due to the rarity of TETs, no data addressing this hypothesis are available.

METHODS

Patients with TETs who received SARS-CoV-2 vaccine, treated in 4 referral centres of the Italian Collaborative Group for ThYmic MalignanciEs (TYME) network between February 2021 and September 2021, were interviewed through a standardised 15-items questionnaire in order to describe the safety of SARS-CoV-2 vaccine in patients affected by TETs.

RESULTS

Data from 245 doses of vaccine administered to 126 patients (41 = thymic carcinoma, 85 = thymoma; 38 with AD, of which 26 with active AD) were collected. Nine patients had a previous COVID-19-positive swab. No cases of AD reactivation or worsening of a pre-existing AD were seen in the study population. A new diagnosis of myasthenia gravis likely unrelated to the vaccine was made in two patients after the vaccination. Sixty-four patients (51%) experienced a total of 103 adverse events, all G1/G2, most commonly fatigue, new or worsening muscle pain and chills. None AE required patients' hospitalisation.

CONCLUSIONS

SARS-CoV-2 mRNA vaccines appear to be safe in patients with TET, even in case of active or pre-existing AD.

摘要

背景

国际指南推荐为癌症患者接种严重急性呼吸综合征冠状病毒2(SARS-CoV-2)疫苗。胸腺上皮肿瘤(TET)患者因自身免疫性疾病(AD)风险高,可能存在发生疫苗相关自身免疫毒性的重大风险。此外,已显示SARS-CoV-2刺突蛋白抗体与各种组织蛋白之间存在交叉反应,并且核蛋白抗体在与刺突蛋白抗体的自身免疫交叉反应中显示出重叠。由于TET罕见,尚无针对该假设的数据。

方法

2021年2月至2021年9月期间,在意大利胸腺恶性肿瘤协作组(TYME)网络的4个转诊中心接受SARS-CoV-2疫苗治疗的TET患者,通过一份标准化的15项问卷进行访谈,以描述SARS-CoV-2疫苗在TET患者中的安全性。

结果

收集了126例患者(41例胸腺癌,85例胸腺瘤;38例患有AD,其中26例为活动性AD)接种的245剂疫苗的数据。9例患者既往新冠病毒检测呈阳性。研究人群中未观察到AD复发或既往AD恶化的病例。两名患者在接种疫苗后被诊断为可能与疫苗无关的重症肌无力。64例患者(51%)共经历了103次不良事件,均为1/2级,最常见的是疲劳、新发或加重的肌肉疼痛和寒战。无一例不良事件需要患者住院治疗。

结论

SARS-CoV-2 mRNA疫苗在TET患者中似乎是安全的,即使是在患有活动性或既往AD的情况下。

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