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多发性骨髓瘤随机对照试验中的患者报告的结果领域以及与生存结果的关联

Darshi Shah¹, Francesco Sparano², Catherine Luo¹

¹Renaissance School of Medicine at Stony, Brook University, Stony Brook, NY, 11790, USA.

Annals of hematology

|December 7, 2024

概括

多发性骨髓瘤临床试验中的患者报告结果 (PROs) 显示了显著的改善,特别是在生活质量和疼痛方面. 这些PRO显示出与整体存活率的显著关联,突出显示了它们在治疗疗效方面的重要性.

科学领域:

在瘤学瘤学.
临床试验方法论临床试验方法论
患者报告的结果

背景情况:

患者报告结果 (PROs) 在多发性骨髓瘤 (MM) 随机对照试验 (RCTs) 中至关重要.
目前的MMRCT中PRO的方法和报告显示出相当大的变化.
需要标准化,以充分利用PRO数据来评估治疗疗效.

研究的目的:

在MM RCT中经常识别预先规定的PRO领域.
确定哪些PRO领域对当代MM疗法最有反应.
调查PRO和无进展生存率 (PFS) 或总生存率 (OS) 之间的相关性.

主要方法:

使用EORTC QLQ-C30问卷对MM RCT进行系统审查.
包括2014年1月至2023年6月期间发表的研究.
使用费舍尔的精确测试或皮尔森的千平方测试分析PRO和PFS/OS之间的关联.

主要成果:

总共审查了35个RCT;PROs是次要/探索性终点.
全球健康状况/生活质量,身体功能,疲劳和疼痛是最常见的预先指定的PRO领域.
超过65%的试验在至少一个PRO领域显著改善,特别是GHS/QoL,疼痛,疲劳和身体功能.
在57.6%的试验中,PROs与PFS一致,在71%的试验中与OS一致 (p=0.018).

结论:

对现代疗法有反应的关键PRO领域被确定为MMRCT中作为主要终点的潜在用途.
PRO和OS之间的显著关联强调了它们在评估治疗有效性的价值.
更有效地整合PRO可以提供对多发性骨髓瘤治疗益处的全面了解.

关键词:

多发性骨髓瘤是多发性骨髓瘤的一种.患者报告的结果随机对照试验是随机对照试验.

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