A retrospective analysis of cardiovascular adverse events associated with immune checkpoint inhibitors.

A retrospective analysis of cardiovascular adverse events associated with immune checkpoint inhibitors.
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DOI:
10.1186/s40959-021-00106-x
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发表时间:
2021-05-28
期刊:
Cardio-oncology (London, England)
影响因子:
--
通讯作者:
Cheng F
Cheng F
中科院分区:
其他
文献类型:
--
作者:
Lal JC;Brown SA;Collier P;Cheng F

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肿瘤学的现代疗法增加了癌症存活率以及心血管不良事件的发生率。虽然免疫检查点抑制剂在几种癌症类型中显示出显著的临床影响,但免疫相关心血管(CV)不良事件的发生率构成了额外的健康问题,并已被报道。我们对2010年1月至2020年3月期间FDA不良事件报告系统中关于免疫治疗和经典化疗的可疑产品报告数据进行了回顾性分析。我们确定了90,740例与免疫检查点抑制剂和经典化疗相关的不良事件报告。我们发现心肌炎与接受抗程序性细胞死亡蛋白1(PD-1)或抗程序性死亡配体1(PD-L1)治疗的患者显著相关,比值比(OR)= 23.86(95%置信区间[CI] 11.76-48.42,(调整的p值)q < 0.001),联合免疫疗法,OR = 7.29(95% CI 1.03-51.89,q = 0.047)。与PD-(L)1相比,化疗中心力衰竭显著相关,OR = 0.50(95% CI 0.37-0.69,q < 0.001),CTLA 4,OR = 0.08(95% CI 0.03-0.20,q < 0.001),联合免疫治疗OR = 0.25(95% CI 0.13-0.48,q < 0.001)。此外,我们观察到男性在心律失常心脏不良反应报告中的性别特异性,OR = 0.81(95%CI 0.75-0.87,q < 0.001),冠心病,0.63(95%CI 0.53-0.76,q < 0.001),心肌梗死,OR = 0.60心肌炎OR = 0.59(95% CI 0.47-0.75,q <0.001),心包炎OR = 0.5(95% CI 0.35-0.73,q < 0.001)。我们的研究提供了与常规化疗相比,免疫治疗患者心脏不良事件的当前风险估计。了解使免疫治疗的癌症患者易于发生通常致命的CV不良事件的临床风险因素对于肿瘤学管理至关重要。在线版本包含补充材料,可通过10.1186/s40959-021-00106-x获得。
Modern therapies in oncology have increased cancer survivorship, as well as the incidence of cardiovascular adverse events. While immune checkpoint inhibitors have shown significant clinical impact in several cancer types, the incidence of immune-related cardiovascular (CV) adverse events poses an additional health concern and has been reported. We performed a retrospective analysis of the FDA Adverse Event Reporting System data of suspect product reports for immunotherapy and classical chemotherapy from January 2010–March 2020. We identified 90,740 total adverse event reports related to immune checkpoint inhibitors and classical chemotherapy. We found that myocarditis was significantly associated with patients receiving anti-program cell death protein 1 (PD-1) or anti-program death ligand 1 (PD-L1), odds ratio (OR) = 23.86 (95% confidence interval [CI] 11.76–48.42, (adjusted p-value) q <  0.001), and combination immunotherapy, OR = 7.29 (95% CI 1.03–51.89, q = 0.047). Heart failure was significantly associated in chemotherapy compared to PD-(L)1, OR = 0.50 (95% CI 0.37–0.69, q <  0.001), CTLA4, OR = 0.08 (95% CI 0.03–0.20, q <  0.001), and combination immunotherapy, OR = 0.25 (95% CI 0.13–0.48, q <  0.001). Additionally, we observe a sex-specificity towards males in cardiac adverse reports for arrhythmias, OR = 0.81 (95% CI 0.75–0.87, q <  0.001), coronary artery disease, 0.63 (95% CI 0.53–0.76, q <  0.001), myocardial infarction, OR = 0.60 (95% CI 0.53–0.67, q <  0.001), myocarditis, OR = 0.59 (95% CI 0.47–0.75, q <  0.001) and pericarditis, OR = 0.5 (95% CI 0.35–0.73, q <  0.001). Our study provides the current risk estimates of cardiac adverse events in patients treated with immunotherapy compared to conventional chemotherapy. Understanding the clinical risk factors that predispose immunotherapy-treated cancer patients to often fatal CV adverse events will be crucial in Cardio-Oncology management. The online version contains supplementary material available at 10.1186/s40959-021-00106-x.
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发表时间: 2020-09-11
期刊: Science (New York, N.Y.)
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