Patient-Reported Outcomes in FLAURA2: Osimertinib with or without Chemotherapy in Patients with Previously Untreated EGFR-Mutated Advanced Non-Small Cell Lung Cancer.

Combining osimertinib with chemotherapy increased induction grade ≥3 adverse eventrates, which reduced during maintenance.

将奥希替尼与化疗联合使用增加了诱导治疗期间3级或更高级别的不良事件发生率，但在维持治疗期间有所减少。

We report FLAURA2 patient-reported outcomes (PRO).

我们报告了FLAURA2患者报告的结果（PRO）。

patients_and_methods

Health-related quality of life (HRQoL) was measured using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 (baseline, week 4, week 7, week 10, then every 6 weeks until progression) and QLQ Lung Cancer 13 (baseline, weekly until week 10, then every 3 weeks until progression).

使用欧洲癌症研究与治疗组织生活质量问卷（QLQ）核心30（基线，第4周，第7周，第10周，然后每6周直至疾病进展）和QLQ肺癌13（基线，每周直至第10周，然后每3周直至疾病进展）来测量健康相关生活质量（HRQoL）。

Score changes (baseline to progression/19 months) were analyzed by mixed models for repeated measures.

通过混合效应模型对重复测量进行分析，以评估基线至进展/19个月的评分变化。

Within-patient ≥10-point changes from baseline were considered clinically meaningful.

从基线开始的患者内评分变化≥10分被认为是具有临床意义的。

Tolerability was assessed by PRO-Common Terminology Criteria for Adverse Events (CTCAE).

耐受性通过患者报告的结果-不良事件通用术语标准（CTCAE）进行评估。

Results

Patients had intermediate-to-high baseline functioning and global health status (GHS)/QoL (mean scores ≥63), with mild symptomatology (≤35).

患者具有中等到高的基线功能和全球健康状况（GHS）/生活质量（QoL）（平均得分≥63），症状轻微（≤35）。

Most key scales showed nonclinically meaningful improvements; average least-squares mean (LSM) changes [95% confidence interval(CI)] for GHS/QoL and physical function, respectively, were 3.32 (1.67-4.98) and 2.37 (0.70-4.04) with combination therapy and 7.38 (5.70-9.07) and 6.74 (5.04-8.43) with monotherapy.

大多数关键量表显示出非临床意义上的改善；平均最小二乘均值（LSM）变化[95%置信区间（CI）]对于总体健康状况/生活质量（GHS/QoL）和身体功能，分别在联合治疗中为3.32（1.67-4.98）和2.37（0.70-4.04），在单一治疗中为7.38（5.70-9.07）和6.74（5.04-8.43）。

Improvements in cough were clinically meaningful with combination therapy and monotherapy from week 5 (except monotherapy at week 73); average LSM changes (95% CI) were -13.23 (-14.85 to -11.62) and -11.19 (-12.83 to -9.55), respectively.

从第5周开始，联合治疗和单一治疗在咳嗽改善方面具有临床意义（单一治疗在第73周除外）；平均最小二乘均值变化（95%置信区间）分别为-13.23（-14.85至-11.62）和-11.19（-12.83至-9.55）。

Nonclinically meaningful deteriorations in fatigue and appetite loss were seen with the combination during induction.

在诱导治疗期间，观察到疲劳和食欲减退在联合治疗中出现了非临床意义上的恶化。

Both treatments were similarly well tolerated (PRO-CTCAE).

两种治疗的耐受性相似（PRO-CTCAE）。

Conclusions

In FLAURA2, osimertinib monotherapy and combination with platinum-pemetrexed as first-line treatment for EGFR-mutated advanced NSCLC had nonclinically meaningful impacts on HRQoL in mildly symptomatic patients.

在FLAURA2研究中，对于轻度症状的EGFR突变晚期非小细胞肺癌患者，作为一线治疗的奥希替尼单药治疗和与铂类-培美曲塞联合治疗对健康相关生活质量（HRQoL）的影响在临床上并不显著。