抗癌药物联合应用阿哌沙班或达肝素对癌症相关静脉血栓栓塞患者复发和出血的影响。
Effects of concomitant administration of anticancer agents and apixaban or dalteparin on recurrence and bleeding in patients with cancer-associated venous thromboembolism.
机构信息
Internal, Vascular and Emergency Medicine - Stroke Unit, University of Perugia, Perugia, Italy.
Medical Oncology Department, Hospital General Universitario Gregorio Marañón, Universidad, Complutense, Madrid, Spain.
出版信息
Eur J Cancer. 2021 May;148:371-381. doi: 10.1016/j.ejca.2021.02.026. Epub 2021 Mar 26.
BACKGROUND
Whether concomitant administration of anticancer agents influences the efficacy and safety of oral anticoagulants in patients treated for cancer-associated venous thromboembolism (VTE) is undefined. The pharmacological interaction between anticancer agents and direct oral anticoagulants is perceived as a concern.
METHODS
We evaluated the effects of concomitant administration of anticancer agents on recurrent VTE, major bleeding and death in patients with cancer-associated VTE randomised to receive apixaban or dalteparin in the Caravaggio study.
RESULTS
Anticancer agents were concomitantly given to 336 patients (58.3%) treated with apixaban and to 332 patients (57.3%) treated with dalteparin. In patients treated with apixaban, recurrent VTE occurred in 20 (6.0%) and 12 (5.0%) among patients treated or not treated with anticancer agents, respectively (hazard ratio [HR] = 1.14; 0.55-2.38); major bleeding occurred in 12 (3.6%) and 10 (4.2%) patients , respectively (HR = 0.79; 0.34-1.82), and death occurred in 74 (22.0%) and 61 (25.4%) patients , respectively (HR = 0.71; 0.51-1.00). In patients treated with dalteparin, recurrent VTE occurred in 24 (7.2%) and 22 (8.9%) among patients treated or not treated with anticancer agents, respectively (HR = 0.71; 0.40-1.28); major bleeding occurred in 16 (4.8%) and 7 (2.8%) patients, respectively (HR = 1.78; 0.66-4.79), and death occurred in 87 (26.2%) and 66 (26.7%) patients, respectively (HR = 0.85; 0.62-1.18). The comparative efficacy and safety of apixaban and dalteparin was not different in patients treated or not treated with anticancer agents. No effect on recurrent VTE, major bleeding or death was observed with inhibitors or inducers of P-glycoprotein and/or CYP3A4.
CONCLUSION
In our study, concomitant administration of anticancer agents had no effect on the risk of VTE recurrence or major bleeding in patients treated with apixaban or dalteparin for cancer-associated VTE.
背景
在接受癌症相关静脉血栓栓塞症（VTE）治疗的患者中，同时使用抗癌药物是否会影响口服抗凝剂的疗效和安全性尚不清楚。抗癌药物与直接口服抗凝剂之间的药物相互作用被认为是一个关注点。
方法
我们评估了在 Caravaggio 研究中，接受阿哌沙班或达肝素治疗的癌症相关 VTE 患者中同时使用抗癌药物对复发性 VTE、大出血和死亡的影响。
结果
336 例（58.3%）接受阿哌沙班治疗和 332 例（57.3%）接受达肝素治疗的患者同时使用了抗癌药物。在接受阿哌沙班治疗的患者中，分别有 20 例（6.0%）和 12 例（5.0%）接受或不接受抗癌药物治疗的患者发生复发性 VTE（风险比[HR]为 1.14；0.55-2.38）；分别有 12 例（3.6%）和 10 例（4.2%）接受或不接受抗癌药物治疗的患者发生大出血（HR 为 0.79；0.34-1.82），分别有 74 例（22.0%）和 61 例（25.4%）接受或不接受抗癌药物治疗的患者死亡（HR 为 0.71；0.51-1.00）。在接受达肝素治疗的患者中，分别有 24 例（7.2%）和 22 例（8.9%）接受或不接受抗癌药物治疗的患者发生复发性 VTE（HR 为 0.71；0.40-1.28）；分别有 16 例（4.8%）和 7 例（2.8%）接受或不接受抗癌药物治疗的患者发生大出血（HR 为 1.78；0.66-4.79），分别有 87 例（26.2%）和 66 例（26.7%）接受或不接受抗癌药物治疗的患者死亡（HR 为 0.85；0.62-1.18）。接受抗癌药物治疗或不治疗的患者，阿哌沙班和达肝素的疗效和安全性无差异。未观察到 P-糖蛋白和/或 CYP3A4 抑制剂或诱导剂对复发性 VTE、大出血或死亡有影响。
结论
在我们的研究中，同时使用抗癌药物对接受阿哌沙班或达肝素治疗的癌症相关 VTE 患者的 VTE 复发或大出血风险没有影响。
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