在肺癌和胃肠道癌症的风险导向的门诊血栓预防:TARGET-TP随机临床试验
Marliese Alexander1,2, Sam Harris3, Craig Underhill4,5
1Department of Pharmacy, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.
JAMA oncology
|September 21, 2023
概括
使用生物标志物的风险导向血栓预防在患有肺癌和胃肠道癌症的患者中显著降低了血栓栓塞. 这种方法也降低了死亡率,而没有增加出血风险,使高风险和低风险个体受益.
科学领域:
- 在瘤学瘤学.
- 血液学 血液学 血液学
- 临床试验 临床试验
背景情况:
- 系统性抗癌疗法增加了血栓栓塞的风险,需要有效的预防.
- 现有的风险模型显示肺癌和胃肠癌队列的局限性.
- 生物标志物驱动的策略可以优化血栓预防的好处.
研究的目的:
- 评估生物标志物驱动血栓预防的临床益处和安全性.
- 为肺癌和胃肠道癌症患者外部验证生物标志物血栓形成风险评估模型.
- 评估风险导向血栓预防对血栓栓塞,出血和生存的影响.
主要方法:
- 一个开放的,第三阶段随机临床试验 (TARGET-TP),涉及接受肺癌或胃肠道癌症全身抗癌疗法的成年人.
- 风险分层使用纤维素和d-二次体水平分为低风险 (观察) 和高风险 (随机) 队列.
- 高风险患者被随机分配给埃诺沙巴林或没有血栓预防;主要结局是180天后确诊的血栓栓塞.
主要成果:
- 血栓栓塞栓症发生在8%的高危患者中,受埃诺沙巴林治疗,而在高危对照组中为23% (HR,0.31;P=.005).
- 低风险个体患有8%的血栓栓塞,而高风险对照人群患有23%.
- 在所有组中,主要出血率都很低 (1-2%);用埃诺沙巴林减少了6个月死亡率 (13%对高风险对照组的26%).
结论:
- 以生物标志物为指导的风险导向血栓预防,有效地减少了肺癌和胃肠癌患者的血栓栓塞.
- 该策略显示了治疗所需的有利人数和改善的生存率,没有安全问题.
- 基于生物标志物的风险分层允许有针对性的干预措施,避免低风险患者不必要的治疗.
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