The role of aspirin in the prevention of thrombotic complications of thalidomide and anthracycline-based chemotherapy for multiple myeloma
The role of aspirin in the prevention of thrombotic complications of thalidomide and anthracycline-based chemotherapy for multiple myeloma
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DOI：
10.4065/80.12.1568
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发表时间：
2005-12-01
影响因子：
8.9
通讯作者：
Hussein, MA
中科院分区：
文献类型：
--
作者：
Baz, R;Li, L;Hussein, MA
目的：研究每日小剂量阿司匹林的疗效（口服81 mg）在接受聚乙二醇化多柔比星、长春新碱和降频地塞米松加沙利度胺（DVD-T）的多发性骨髓瘤患者中降低静脉血栓栓塞事件（VTE）的发生率。在克利夫兰临床基金会于2001年8月至2003年10月进行的DVD-T的2期临床试验中，招募了105名患者。前35例患者发生VTE数量增加。在用DVD-T治疗之前和之后，血管性血友病因子水平和血小板对瑞斯托康的聚集显著增加，表明涉及血小板-内皮相互作用的病理生理学。方案中添加阿司匹林，因此产生3个患者组：组I在研究开始前从DVD-T治疗开始时接受阿司匹林（58例患者），组2在DVD-T治疗开始后和研究开始后接受阿司匹林（26例患者），组3在研究期间未接受每日低剂量阿司匹林（19例患者）。2例因其他适应症接受华法林治疗的患者从研究中排除。本研究的主要终点是以深静脉血栓形成或肺栓塞形式出现的WE的发生率。次要终点的时间firrst静脉血栓栓塞，时间的复合终点死亡或首次静脉血栓栓塞，出血complications.Results的发生率：经过中位随访24个月，在意向治疗的基础上，26治疗后静脉血栓栓塞发生后，中位数为90天，19%发生在第1组，15%在第2组，58%在第3组。多变量时间事件分析后，阿司匹林的使用仍然与WE的相对风险较低相关（风险比，0.22;置信区间，0.10-0.47; P < .001）和复合终点（风险比，0.28;置信区间，0.15-0.51; P <0.001）。每日低剂量阿司匹林（81 mg口服）给予接受Dvd治疗的新诊断和复发/难治性多发性骨髓瘤患者，T降低了VTE的发生率，而没有增加出血并发症。
OBJECTIVE: To study the efficacy of daily low-dose aspirin (81 mg orally) in decreasing the incidence of venous thromboembolic events (VTEs) in patients with multiple myeloma receiving pegylated doxorubicin, vincristine, and decreased-frequency dexamethasone, plus thalidomide (DVd-T).PATIENTS AND METHODS: In this phase 2 clinical trial of DVd-T, conducted by the Cleveland Clinic Foundation from August 2001 to October 2003, 105 patients were enrolled. The first 35 patients experienced Increased numbers of VTEs. von Willebrand levels and platelet aggregation to ristocetin before and after treatment with DVd-T increased significantly, suggesting a pathophysiology involving platelet-endothelial interaction. Aspirin was added to the regimen, thus generating 3 patient groups: group I received aspirin from the start of DVd-T treatment before the study began (58 patients), group 2 received aspirin after the start of DVd-T treatment and after the study began (26 patients), and group 3 did not receive daily low-dose aspirin during the study (19 patients). Two patients being treated with warfarin for other Indications were excluded from the study. The primary end point for this study was the Incidence of WE in the form of either deep venous thrombosis or pulmonary embolism. Secondary end points were the time to the flrst VTE, time to the composite end point of death or first VTE, and Incidence of bleeding complications.RESULTS: After a median follow-up of 24 months, on an Intent-to-treat basis, 26 posttreatment VTEs occurred after a median of 90 days, with 19% occurring In group 1, 15% in group 2, and 58% in group 3. Following multivariate time-to-event analysis, aspirin use continued to be associated with lower relative risk of WE (hazard ratio, 0.22; confidence interval, 0.10-0.47; P < .001) and of the composite end point (hazard ratio, 0.28; confidence interval, 0.15-0.51; P < .001).CONCLUSION: Daily low-dose aspirin (81 mg orally) given to patients with newly diagnosed and relapsed/refractory multiple myeloma who were receiving DVd-T reduced the Incidence of VTEs without an increase in bleeding complications.