关于接受西妥昔单抗联合化疗的患者发生静脉和动脉血栓栓塞（VTE 和 ATE）风险的数据有限。我们的目的是确定接受西妥昔单抗联合化疗与单独化疗相比的复发/转移性结直肠癌 (CRC) 患者的血栓栓塞风险。这项基于人群的研究使用了韩国健康保险审查和评估服务局 2013 年以来的全国索赔数据到 2020 年。纳入了接受一线奥沙利铂或伊立替康双药联合或不联合西妥昔单抗治疗且未进行 VTE 和 ATE 二级预防的复发/转移性 CRC 患者。主要结局是任何血栓栓塞事件、VTE 和 ATE 的发生，这些事件是使用累积发生率法将死亡作为竞争事件来确定的。我们确定了 19,723 名患者（西妥昔单抗加化疗，N = 7630；单独化疗，N = 12,093） 。接受西妥昔单抗联合化疗的患者中任何血栓栓塞事件的累积发生率均显着高于接受单独化疗的患者（6 个月，5.62% vs. 3.58%，P < 0.0001）。接受西妥昔单抗联合化疗的患者的 VTE（6 个月，5.11% vs. 3.28%，P < 0.0001）和 ATE（6 个月，0.53% vs. 0.32%，P = 0.0218）发生率也较高。在多变量分析中，西妥昔单抗加化疗与任何血栓栓塞事件的发生独立相关（风险比 [HR]，1.63；95% 置信区间 [CI]，1.42-1.87）、VTE（HR，1.62；95% CI，1.40-1.87） ）和 ATE（HR，1.77；95% CI，1.16-2.71）。西妥昔单抗联合伊立替康或奥沙利铂双联化疗与任何血栓栓塞事件、VTE 和 ATE 的风险增加相关；有必要进行进一步研究以检验其潜在机制。版权所有 © 2023。由 Elsevier Ltd 出版。

Limited data exist on the risk of venous and arterial thromboembolisms (VTE and ATE) in patients receiving cetuximab plus chemotherapy. We aimed to determine the thromboembolic risk of patients with recurrent/metastatic colorectal cancer (CRC) treated with cetuximab plus chemotherapy compared to chemotherapy alone.This population-based study used nationwide claims data from the Health Insurance Review and Assessment Service of South Korea from 2013 to 2020. Patients with recurrent/metastatic CRC treated with first-line oxaliplatin- or irinotecan-based doublets with or without cetuximab and no secondary prevention for VTE and ATE were included. Primary outcomes were the occurrence of any thromboembolic events, VTE, and ATE, which were determined using the cumulative incidence method incorporating death as a competing event.We identified 19,723 patients (cetuximab plus chemotherapy, N = 7630; chemotherapy alone, N = 12,093). The cumulative incidence of any thromboembolic events in patients with cetuximab plus chemotherapy was significantly higher than in those receiving chemotherapy alone (6-month, 5.62 % vs. 3.58 %, P < 0.0001). The rates of VTE (6-month, 5.11 % vs. 3.28 %, P < 0.0001) and ATE (6-month, 0.53 % vs. 0.32 %, P = 0.0218) were also higher in patients receiving cetuximab plus chemotherapy. In multivariable analysis, cetuximab plus chemotherapy was independently associated with developing any thromboembolic events (hazard ratio [HR], 1.63; 95 % confidence interval [CI], 1.42-1.87), VTE (HR, 1.62; 95 % CI, 1.40-1.87), and ATE (HR, 1.77; 95 % CI, 1.16-2.71).Cetuximab with irinotecan- or oxaliplatin-based doublet chemotherapy was associated with an increased risk of any thromboembolic events, VTE, and ATE; further studies are warranted to examine the underlying mechanisms.Copyright © 2023. Published by Elsevier Ltd.