PDF(Pubmed)
Abstract：
UNASSIGNED: Thromboembolic events with the use of immune checkpoint inhibitors (ICIs) in patients with cancer have been reported in few studies. However, the detailed profile of these cases remains mostly uncertain.
UNASSIGNED: A descriptive analysis of Thromboembolic events associated with ICIs retrieved from the VigiBase, between 1967 to November 2020. We extracted the data using the terms of \'pulmonary embolism\' OR \'deep vein thrombosis\' OR \'acute coronary syndrome\' OR \'myocardial infarction\' OR \'ischemic stroke\' (preferred term (PT) (MedDRA).
UNASSIGNED: We included 161 cases from 26 countries in our descriptive analysis. Patients\' ages were reported in 141 (87.6%) cases, with a median of 68 years (interquartile range 61-74), and 63.4% of the patients were male. Indications for ICIs were reported in 151 (93.8%) cases, as follows: lung cancer (n = 85, 52.8%), renal cell carcinoma (n = 24, 14.9%), melanoma (n = 20, 12.4%), urethral carcinoma (n = 12, 7.45%), breast cancer (n = 4, 2.48%), adenocarcinoma of the gastroesophageal junction (n = 3, 1.9%), gastric cancer (n = 2, 1.24%), and skin cancer (n = 1, 0.62%). Nivolumab was reported as a suspected drug in 76 cases (47%), pembrolizumab in 46 cases (28.5%), atezolizumab in 21 cases (13%), durvalumab in 14 cases (8.6%), and avelumab in four cases (2.4%).The time to onset of thromboembolic events was reported in 127 (78.8%) cases. Most of these patients (n = 109, 85.8%) reported thromboembolic events within the first six months. The causality assessment of included cases showed that 50.3% of reported thromboembolic events were possibly related to the suspected reported medication, 13.7% were probably related, 13% were unlikely to be related, and 23% were not assessable due to insufficient information.
UNASSIGNED: This study demonstrates a possible association between the use of ICIs and thromboembolic events. Further epidemiological studies are needed to assess this association and to elucidate the underlying mechanism.
UNASSIGNED: A descriptive analysis of Thromboembolic events associated with ICIs retrieved from the VigiBase, between 1967 to November 2020. We extracted the data using the terms of \'pulmonary embolism\' OR \'deep vein thrombosis\' OR \'acute coronary syndrome\' OR \'myocardial infarction\' OR \'ischemic stroke\' (preferred term (PT) (MedDRA).
UNASSIGNED: We included 161 cases from 26 countries in our descriptive analysis. Patients\' ages were reported in 141 (87.6%) cases, with a median of 68 years (interquartile range 61-74), and 63.4% of the patients were male. Indications for ICIs were reported in 151 (93.8%) cases, as follows: lung cancer (n = 85, 52.8%), renal cell carcinoma (n = 24, 14.9%), melanoma (n = 20, 12.4%), urethral carcinoma (n = 12, 7.45%), breast cancer (n = 4, 2.48%), adenocarcinoma of the gastroesophageal junction (n = 3, 1.9%), gastric cancer (n = 2, 1.24%), and skin cancer (n = 1, 0.62%). Nivolumab was reported as a suspected drug in 76 cases (47%), pembrolizumab in 46 cases (28.5%), atezolizumab in 21 cases (13%), durvalumab in 14 cases (8.6%), and avelumab in four cases (2.4%).The time to onset of thromboembolic events was reported in 127 (78.8%) cases. Most of these patients (n = 109, 85.8%) reported thromboembolic events within the first six months. The causality assessment of included cases showed that 50.3% of reported thromboembolic events were possibly related to the suspected reported medication, 13.7% were probably related, 13% were unlikely to be related, and 23% were not assessable due to insufficient information.
UNASSIGNED: This study demonstrates a possible association between the use of ICIs and thromboembolic events. Further epidemiological studies are needed to assess this association and to elucidate the underlying mechanism.
摘要：
未经证实：在癌症患者中使用免疫检查点抑制剂（ICIs）的血栓栓塞事件的报道很少。然而,这些病例的详细概况仍不确定。
UNASSIGNED：从VigiBase检索到的与ICIs相关的血栓栓塞事件的描述性分析，1967年至2020年11月。我们使用“肺栓塞”或“深静脉血栓形成”或“急性冠脉综合征”或“心肌梗死”或“缺血性卒中”（首选术语（PT）（MedDRA）。
UNASSIGNED：我们在描述性分析中纳入了来自26个国家的161例病例。141例(87.6%)报告患者年龄，中位数为68岁（四分位距61-74），63.4%的患者为男性。在151例（93.8％）中报告了ICI的适应症，如下：肺癌（n=85，52.8%），肾细胞癌（n=24，14.9%），黑色素瘤（n=20，12.4%），尿道癌（n=12，7.45%），乳腺癌（n=4，2.48%），胃食管交界处腺癌（n=3，1.9％），胃癌（n=2，1.24%），和皮肤癌（n=1，0.62％）。Nivolumab被报告为76例（47％）的可疑药物，帕姆单抗46例（28.5%），阿替珠单抗21例（13%），durvalumab14例（8.6%），和阿维鲁单抗4例（2.4%）。127例（78.8%）病例报告发生血栓栓塞事件的时间。这些患者中的大多数（n=109，85.8％）在前六个月内报告了血栓栓塞事件。纳入病例的因果关系评估显示，50.3%的报告血栓栓塞事件可能与可疑报告药物有关。13.7%可能是相关的，13%不太可能是相关的，23％由于信息不足而无法评估。
UNASSIGNED：本研究表明ICIs的使用与血栓栓塞事件之间可能存在关联。需要进一步的流行病学研究来评估这种关联并阐明潜在的机制。
UNASSIGNED：从VigiBase检索到的与ICIs相关的血栓栓塞事件的描述性分析，1967年至2020年11月。我们使用“肺栓塞”或“深静脉血栓形成”或“急性冠脉综合征”或“心肌梗死”或“缺血性卒中”（首选术语（PT）（MedDRA）。
UNASSIGNED：我们在描述性分析中纳入了来自26个国家的161例病例。141例(87.6%)报告患者年龄，中位数为68岁（四分位距61-74），63.4%的患者为男性。在151例（93.8％）中报告了ICI的适应症，如下：肺癌（n=85，52.8%），肾细胞癌（n=24，14.9%），黑色素瘤（n=20，12.4%），尿道癌（n=12，7.45%），乳腺癌（n=4，2.48%），胃食管交界处腺癌（n=3，1.9％），胃癌（n=2，1.24%），和皮肤癌（n=1，0.62％）。Nivolumab被报告为76例（47％）的可疑药物，帕姆单抗46例（28.5%），阿替珠单抗21例（13%），durvalumab14例（8.6%），和阿维鲁单抗4例（2.4%）。127例（78.8%）病例报告发生血栓栓塞事件的时间。这些患者中的大多数（n=109，85.8％）在前六个月内报告了血栓栓塞事件。纳入病例的因果关系评估显示，50.3%的报告血栓栓塞事件可能与可疑报告药物有关。13.7%可能是相关的，13%不太可能是相关的，23％由于信息不足而无法评估。
UNASSIGNED：本研究表明ICIs的使用与血栓栓塞事件之间可能存在关联。需要进一步的流行病学研究来评估这种关联并阐明潜在的机制。
