BACKGROUND In the FLAURA trial, osimertinib demonstrated superior progression-free survival and a favorable toxicity profile to erlotinib or gefitinib as initial therapy in patients with EGFR-mutated advanced non-small-cell lung cancer. Patient-reported outcomes from FLAURA are discussed here. METHODS Patients (N = 556) completed the EORTC QLQ-LC13 weekly for 6 weeks, then every 3 weeks, and the QLQ-C30 every 6 weeks. Prespecified key symptoms were cough, dyspnea, chest pain, appetite loss, and fatigue. Score changes from baseline to randomized treatment discontinuation were assessed using a mixed-effects model. A ≥10-point change was considered clinically relevant. Odds of improvement and time to deterioration were investigated. QLQ-C30 functioning scores were assessed post hoc. RESULTS Questionnaire completion rates were >70% at most time points. Baseline mean scores were similar in the osimertinib and erlotinib/gefitinib arms. Scores improved in both arms, but none reached clinical relevance at 5% significance level. A statistically significant difference favoring osimertinib for chest pain was not clinically relevant (-6.84 vs -3.88; p = 0.021). Odds of improvement and time to deterioration were similar between treatments. In post hoc analyses, improvements favored osimertinib for emotional functioning (8.79 vs 4.91; p = 0.004) and social functioning (7.66 vs 1.74; p < 0.001). Cognitive functioning remained stable with osimertinib but deteriorated with erlotinib/gefitinib (0.03 vs -3.91; p = 0.005). CONCLUSIONS Key symptoms improved from baseline in both treatment arms in FLAURA. Key symptom improvements that were both statistically significant and clinically relevant were not observed in favor of either treatment arm. CLINICAL TRIAL REGISTRATION NCT02296125.

中文翻译：

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FLAURA患者报告的结果：EGFR突变晚期非小细胞肺癌患者的奥西替尼与厄洛替尼或吉非替尼比较。

背景技术在FLAURA试验中，作为EGFR突变的晚期非小细胞肺癌患者的初始治疗方法，奥西替尼显示出优异的无进展生存期和对厄洛替尼或吉非替尼有利的毒性。此处讨论了患者报告的FLAURA结果。方法患者（N = 556）每周完成EORTC QLQ-LC13，持续6周，然后每3周完成一次，而QLQ-C30每6周完成一次。预先指定的主要症状是咳嗽，呼吸困难，胸痛，食欲不振和疲劳。使用混合效应模型评估从基线到随机治疗终止的评分变化。≥10分的变化被认为具有临床意义。研究了改进的可能性和恶化的时间。事后评估QLQ-C30功能评分。结果问卷调查完成率> 大多数时间点为70％。奥西替尼和厄洛替尼/吉非替尼组的基线平均评分相似。两组的评分均得到改善，但均未达到5％的临床相关性。在统计学上，赞成奥西替尼治疗胸痛的差异在临床上不相关（-6.84对-3.88； p = 0.021）。治疗之间的改善几率和恶化时间相似。在事后分析中，改善对奥西替尼的情绪功能（8.79 vs 4.91； p = 0.004）和社交功能（7.66 vs 1.74； p <0.001）有利。奥西替尼的认知功能保持稳定，但厄洛替尼/吉非替尼则恶化（0.03 vs -3.91； p = 0.005）。结论FLAURA的两个治疗组的关键症状均较基线改善。在任一治疗组中均未观察到在统计学上和临床上均具有统计学意义的关键症状改善。临床试验注册NCT02296125。