在FLAURA2中患者报告的结果:在以前未经治疗的EGFR突变的先进非小细胞肺癌患者中,用化疗或不使用化疗的奥西默蒂尼布
Jhanelle E Gray1, Konstantin Laktionov2, Sang-We Kim3
1Moffitt Cancer Center Tampa, Florida United States.
概括
第一线 osimertinib 加上化疗改善了EGFR突变非小细胞肺癌 (NSCLC) 的无进展生存期. 患者报告的结果显示,对大多数患者的生活质量没有临床上有意义的影响.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 经EGFR突变的高级非小细胞肺癌 (NSCLC) 是一个重大的临床挑战.
- 第一线治疗方案旨在改善无进展生存率 (PFS) 和保持生活质量 (QoL).
- 奥西默提尼布已经显示出有效性,但其与化疗的结合需要对患者报告的结果 (PRO) 进行评估.
研究的目的:
- 报告来自FLAURA2试验的患者报告结果 (PRO),评估与健康有关的生活质量 (HRQoL) 和耐受性.
- 为了在先进的NSCLC中比较HRQoL和第一线 osimertinib加-pemetrexed诱导/维持和osimertinib单一治疗之间的症状负担.
- 用患者报告的数据评估HRQoL和症状变化的临床意义.
主要方法:
- 在FLAURA2试验中,纳入了EGFR突变高级NSCLC的患者.
- 与健康相关的生活质量 (HRQoL) 通过使用EORTC QLQ-C30和QLQ-LC13问卷以规定的间隔进行评估.
- 使用患者报告的结果评估了耐受性,用于不良事件的常用术语标准 (PRO-CTCAE).
主要成果:
- 患者表现为基线中等至高的功能和全球健康状况 (GHS) /QoL.
- 大多数HRQoL尺度都显示了结合疗法和单一治疗的非临床意义上的改善.
- 临床上有意义的改善观察到咳在两个治疗手臂,而非临床上有意义的疲劳和食欲丧失的恶化发生在诱导期间的组合治疗.
结论:
- 第一线 osimertinib 单疗法和与-pemetrexed 结合疗法在EGFR突变高级NSCLC患者的HRQoL上显示出非临床意义上的影响.
- 这两种治疗策略都被很好地容忍,患者报告的耐受性概况相似.
- 这些发现表明,在接受任何一种治疗方案的轻度症状患者中,HRQoL保持.
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