基于达拉图穆马布的一线治疗对多发性骨髓瘤患者在现实环境中有益:多中心回顾性倾向得分匹配研究
Yun Wang1, Xiaoqin Chen1, Qi Liang1
1Department of Hematologic Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Centre for Cancer, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou, 510060, P. R. China.
在最初的多发性骨髓瘤治疗中添加达拉图穆马布,在现实环境中显著改善了患者的治疗结果. 这种治疗增强了深度缓解,延长了无进展的存活率和整体存活率.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 随机对照试验 (RCT) 显示,达拉图巴改善了新诊断的多发性骨髓瘤 (MM) 的结果.
- 由于患者资格和获得医疗保健的差异,现实世界的数据至关重要.
- 这项研究评估了daratumumab在中国现实世界的有效性.
研究的目的:
- 评估一线达拉图穆马布在新诊断的多发性骨髓瘤 (MM) 中的实际有效性.
- 为了比较与daratumumab治疗和不治疗的患者之间的无进展生存期 (PFS) 和整体生存期 (OS).
主要方法:
- 从2017年到2023年对761名新诊断的MM患者 (177名达拉图穆巴,584名没有) 的分析.
- 倾向分数匹配 (PSM) 创建了可比的队列用于分析.
- 使用国际骨髓瘤工作组标准和可测量的残留疾病 (MRD) 评估通过流细胞计进行反应评估.
主要成果:
- 达拉图马布组显示出更高的非常良好部分响应率 (85.0%对61.3%) 和MRD消极性 (73.0%对51.9%).
- 在达拉图马布手臂中,显著改善了3年的PFS (75.6%对比55.0%) 和OS (78.3%对比74.4%).
- 在增益/amp ((1q21) 中观察到PFS益处,但在del17p或t ((4;14) 中没有发现;在博尔特佐米布/莱纳利多米德/德克萨米他组合中观察到生存益处.
结论:
- 第一线达拉图穆马布治疗改善了现实MM环境中的响应深度,PFS和OS.
- 虽然有益,但并非所有患者都经历了生存优势.
- 现实世界的数据证实了RCT所建议的疗效,特定的遗传标志物影响PFS结果.
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