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德克索鲁比辛加奥拉图马布与德克索鲁比辛加安慰剂对晚期软组织肉瘤患者的生存的影响:
William D Tap1,2, Andrew J Wagner3, Patrick Schöffski4
1Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
JAMA
|April 8, 2020
在PubMed 上查看摘要
概括
在治疗晚期软组织肉瘤 (STS) 时,该第三阶段试验没有发现olaratumab与doxorubicin的整体生存益处. 这些结果并未证实该患者群体早期的第二阶段发现.
科学领域:
- 癌症学
- 临床试验
- 药理学
背景情况:
- 晚期软组织肉瘤 (STS) 的预后不佳,平均整体存活时间低于2年.
- 在先前的第二阶段研究中,奥拉图马布和多克索鲁比辛在晚期的STS患者的生存率有所改善.
研究的目的:
- 在晚期或转移性STS患者中证实多克索鲁比加奥拉图马布的疗效.
- 评估使用多克索鲁比辛和奥拉图马布治疗的STS和肌肉瘤 (LMS) 患者的整体存活率与多克索鲁比辛和安慰剂.
主要方法:
- 一个第三阶段的双盲随机试验 (ANNOUNCE) 涉及509名先前没有服用过 antracycline 的晚期/转移性STS 患者.
- 患者接受多克索鲁比加奥拉图马布或安慰剂治疗,最多持续8个周期,然后再进行单一治疗.
主要成果:
- 对于总体STS或LMS群体,在多克索鲁素加奥拉图马布组和多克索鲁素加安慰剂组之间没有统计学上显著的生存差异.
- 在整个STS群体中,总生存时间的中位数为20. 4个月 (多克索鲁比辛+奥拉图马布) 和19. 7个月 (多克索鲁比辛+安慰剂).
- 常见的3级或更严重的不良反应包括中性质衰竭,白血病和发烧性中性质衰竭.
结论:
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