Efficacy and Safety of Edoxaban in Cancer-Associated Venous Thromboembolism: A Real World Retrospective Study.

TH open : companion journal to thrombosis and haemostasis Pub Date : 2022-03-01 eCollection Date: 2022-04-01 DOI:10.1055/a-1783-9744
Elisa Grifoni, Andrea Baroncelli, Gabriele Pinto, Eleonora Cosentino, Irene Micheletti, Ira Signorini, Grazia Panigada, Giancarlo Landini, Luca Masotti
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Abstract

Introduction  Few data exist on the use of edoxaban in cancer-associated venous thromboembolism (VTE) outside of clinical trials. Aim of this study was to evaluate the characteristics and outcomes of these patients in a real world clinical setting. Methods  We retrospectively analyzed the characteristics of patients with cancer-associated VTE who were prescribed edoxaban. Follow-up at 3, 6, and 12 months was performed: VTE recurrences, bleedings, mortality, cancer progression and treatment, edoxaban interruption and its reason were assessed. Results  Fifty-four patients, 38 females (70.4%), mean age 71 ± 14 years, were enrolled. In 38 patients (70.4%), the episode of VTE was the first one, in 28 (51.8%) it was an isolated deep vein thrombosis (DVT), in 13 (24.1%) a pulmonary embolism (PE) associated with DVT, in 13 (24.1%) an isolated PE. Median time between cancer and VTE diagnosis was 6 (interquartile range [IQR] 2-47) months. Median time between VTE diagnosis and edoxaban prescription was 36 (IQR 7-117) days. At 3, 6, and 12 months the incidence of all-cause mortality was 16.6, 22.2, and 38.8%, that of VTE recurrence 1.8, 1.8, and 3.7%, and that of major bleeding 7.4, 9.2, and 12.9%, respectively. No bleeding was fatal. Of the 33 patients alive at 12 months, 32 (96.9%) were still on edoxaban therapy, in seven (21.2%) cancer was in progression. Conclusion  Our study, conducted on a real world population of patients with cancer-associated VTE, confirms the results of randomized controlled clinical trials, and supports the use of edoxaban as effective and safe treatment in this context.

埃多沙班治疗癌症相关静脉血栓栓塞症的有效性和安全性:一项真实世界的回顾性研究
导言:在临床试验之外,关于埃多沙班用于癌症相关性静脉血栓栓塞症(VTE)的数据很少。本研究旨在评估这些患者在实际临床环境中的特征和预后。方法 我们回顾性分析了处方埃多沙班的癌症相关 VTE 患者的特征。分别进行了 3、6 和 12 个月的随访:对 VTE 复发、出血、死亡率、癌症进展和治疗、依度沙班中断及其原因进行评估。结果 54名患者中有38名女性(70.4%),平均年龄(71±14)岁。38名患者(70.4%)首次发生VTE,28名患者(51.8%)为孤立的深静脉血栓(DVT),13名患者(24.1%)为伴有DVT的肺栓塞(PE),13名患者(24.1%)为孤立的PE。癌症与 VTE 诊断之间的中位时间为 6 个月(四分位数间距 [IQR] 2-47)。VTE 诊断与开具埃多沙班处方之间的中位时间为 36 天(IQR 7-117 天)。3、6和12个月时,全因死亡率分别为16.6%、22.2%和38.8%,VTE复发率分别为1.8%、1.8%和3.7%,大出血率分别为7.4%、9.2%和12.9%。没有出现致命的出血。在 33 名存活 12 个月的患者中,32 人(96.9%)仍在接受依多沙班治疗,7 人(21.2%)的癌症处于进展期。结论 我们的研究在现实世界中的癌症相关 VTE 患者中进行,证实了随机对照临床试验的结果,并支持在这种情况下使用埃多沙班进行有效、安全的治疗。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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