Prediction and prevention of thromboembolic events with enoxaparin in cancer patients with elevated tissue factor-bearing microparticles: a randomized-controlled phase II trial (the Microtec study).

Prediction and prevention of thromboembolic events with enoxaparin in cancer patients with elevated tissue factor-bearing microparticles: a randomized-controlled phase II trial (the Microtec study).
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DOI:
10.1111/bjh.12163
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发表时间:
2013-02
影响因子:
6.5
通讯作者:
Furie B
Furie B
中科院分区:
医学2区
文献类型:
--
作者:
Zwicker JI;Liebman HA;Bauer KA;Caughey T;Campigotto F;Rosovsky R;Mantha S;Kessler CM;Eneman J;Raghavan V;Lenz HJ;Bullock A;Buchbinder E;Neuberg D;Furie B

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循环组织因子携带微粒(TFMP)水平升高与癌症患者发生静脉血栓栓塞(VTE)的风险增加相关。我们进行了一项随机II期研究,以评估未接受血栓预防的TFMP水平较低的晚期癌症患者和随机接受依诺肝素或观察的循环TFMP水平较高的晚期癌症患者的VTE累积发生率。随机分配至依诺肝素的较高TFMP组(N=23)2个月时VTE的累积发生率为5.6%,而较高TFMP组观察组(N=11)为27.3%(灰色检验P=0.06)。低TFMP中VTE的累积发生率为7.2%(N=32)。在依诺肝素组中未观察到大出血,观察后TFMP水平较高的患者的中位生存期为11.8个月,而依诺肝素组为17.8个月(P=0.58)。在一项前瞻性随机试验中,通过阻抗流式细胞术检测到的循环TFMP数量增加确定了VTE发生率高的癌症患者。在TFMP水平升高的患者中,依诺肝素显示出明显的降低VTE发生率的趋势,总体VTE发生率与TFMP水平较低组相似。
Elevated levels of circulating tissue factor-bearing microparticles (TFMP) have been associated with an increased risk of developing venous thromboembolism (VTE) in cancer patients. We performed a randomized phase II study to evaluate the cumulative incidence of VTE in advanced cancer patients with lower levels of TFMP not receiving thromboprophylaxis and those with higher levels of circulating TFMP randomized to enoxaparin or observation. The cumulative incidence of VTE at 2 months in the higher TFMP group randomized to enoxaparin (N=23) was 5.6% while the higher TFMP group observation arm (N=11) was 27.3% (Gray test P=0.06). The cumulative incidence of VTE in the low TFMP was 7.2% (N=32). No major haemorrhages were observed in the enoxaparin arm. The median survival for patients with higher levels of TFMP followed by observation was 11.8 months compared with 17.8 months on enoxaparin (P=0.58). In a prospective randomized trial, increased numbers of circulating TFMP detected by impedance flow cytometry identified cancer patients with a high incidence of VTE. Enoxaparin demonstrated a clear trend towards reducing the rate of VTE in patients with elevated levels of TFMP, with an overall rate of VTE similar in magnitude to the lower TFMP group.
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