Pritchard Elizabeth R, Murillo Jose R, Putney David, Hobaugh Eleanor C
1 1 Department of Pharmacy Practice, 15499 University of Arkansas for Medical Sciences College of Pharmacy , Little Rock, AR, USA.
2 U.S. Oncology Global Medical Affairs, Merck, North Wales, PA, USA.
J Oncol Pharm Pract. 2019 Jan;25(1):52-59. doi: 10.1177/1078155217726158. Epub 2017 Aug 21.
The safety and efficacy of direct oral anticoagulants in cancer patients is currently unclear. Low-molecular-weight heparin remains the standard of care for cancer patients with venous thromboembolism, with warfarin, a vitamin K antagonist, as an alternative. Clear recommendations do not exist for patients with both active cancer and non-valvular atrial fibrillation. The objectives of this study were to report safety and efficacy outcomes of direct oral anticoagulants, low-molecular-weight heparin, and vitamin K antagonist in cancer patients with venous thromboembolism or non-valvular atrial fibrillation.
Retrospective chart review of adult cancer patients from 2012 to 2015 who received an antineoplastic agent and an anticoagulant.
A total of 258 patients were reviewed: 80 patients in direct oral anticoagulant group, 95 patients in low-molecular-weight heparin group, and 83 patients in vitamin K antagonist group. Sixty-seven percent of patients were on an anticoagulant for acute or chronic venous thromboembolism. Major bleeding events were similar across the groups (15% direct oral anticoagulant vs 17% low-molecular-weight heparin vs 18% vitamin K antagonist). The most common type of major bleeding event was gastrointestinal bleeding. A total of five fatal bleeding events occurred. Venous thromboembolism recurrence rates were higher in both direct oral anticoagulant (18%) and low-molecular-weight heparin (12%) groups while lower in vitamin K antagonist group (10%) compared to previous studies.
Cancer patients receiving direct oral anticoagulants, low-molecular-weight heparin, or vitamin K antagonist had similar rates of major bleeding events, with gastrointestinal bleeding being the most common event. Venous thromboembolism recurrence rates were higher in direct oral anticoagulant and low-molecular-weight heparin groups than prior studies. Randomized trials are warranted to establish clear safety and efficacy in this population.
直接口服抗凝剂在癌症患者中的安全性和有效性目前尚不清楚。低分子量肝素仍然是患有静脉血栓栓塞症的癌症患者的护理标准，维生素K拮抗剂华法林则作为一种替代选择。对于同时患有活动性癌症和非瓣膜性心房颤动的患者，目前尚无明确的推荐方案。本研究的目的是报告直接口服抗凝剂、低分子量肝素和维生素K拮抗剂在患有静脉血栓栓塞症或非瓣膜性心房颤动的癌症患者中的安全性和有效性结果。
对2012年至2015年期间接受抗肿瘤药物和抗凝剂治疗的成年癌症患者进行回顾性病历审查。
共审查了258例患者：直接口服抗凝剂组80例，低分子量肝素组95例，维生素K拮抗剂组83例。67%的患者因急性或慢性静脉血栓栓塞症而接受抗凝治疗。各组之间的严重出血事件相似（直接口服抗凝剂组为15%，低分子量肝素组为17%，维生素K拮抗剂组为18%）。最常见的严重出血事件类型是胃肠道出血。总共发生了5例致命出血事件。与先前的研究相比，直接口服抗凝剂组（18%）和低分子量肝素组（12%）的静脉血栓栓塞症复发率较高，而维生素K拮抗剂组（10%）的复发率较低。
接受直接口服抗凝剂、低分子量肝素或维生素K拮抗剂治疗的癌症患者严重出血事件发生率相似，其中胃肠道出血最为常见。直接口服抗凝剂组和低分子量肝素组的静脉血栓栓塞症复发率高于先前的研究。有必要进行随机试验以确定该人群中明确的安全性和有效性。
