Patient-Reported Symptoms and Impact of Treatment With Osimertinib Versus Chemotherapy in Advanced Non-Small-Cell Lung Cancer: The AURA3 Trial
Patient-Reported Symptoms and Impact of Treatment With Osimertinib Versus Chemotherapy in Advanced Non-Small-Cell Lung Cancer: The AURA3 Trial
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DOI：
10.1200/jco.2017.77.2293
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发表时间：
2018-06-20
影响因子：
45.3
通讯作者：
Mok, Tony
中科院分区：
文献类型：
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作者：
Lee, Chee Khoon;Novello, Silvia;Mok, Tony
获取患者报告的结果数据对于评估新癌症治疗的总体临床益处非常重要。我们评估了在AURA 3 III期试验中接受奥希替尼或化疗的患者自我报告的晚期非小细胞肺癌症状。患者和方法患者完成了欧洲癌症研究和治疗组织的13项生活质量量表-肺癌模块（EORTC QLQ-LC 13）疾病特异性症状问卷和EORTC 30项核心生活质量问卷（EORTC QLC-C30）一般癌症症状、功能、总体健康状况/生活质量。我们评估了个体症状恶化时间和改善几率的治疗差异（恶化或改善定义为评分较基线变化10分）。危险比（HR）进行了计算，使用对数秩检验按种族分层的优势比（OR）进行了评估，使用logistic回归调整ethnicity.ResultsAt基线，问卷调查完成了82%至88%的患者，和30%至70%的个别关键症状。奥希替尼组至咳嗽（HR，0. 74; 95% CI，0. 53 - 1. 05）、胸痛（HR，0. 52; 95% CI，0. 37 - 0. 73）和呼吸困难（HR，0. 42; 95% CI，0. 31 - 0. 58）恶化的时间长于化疗组。奥希替尼组总体健康状况/生活质量改善的症状性患者比例（80/215 [37%]）高于化疗组（23/105 [22%]; OR，2.11; 95% CI，1.24 - 3.67; P = .007）。食欲不振的比例也较高（OR，2.50; 95% CI，1.31 - 4.84）和疲劳（OR值为1.96;结论奥希替尼组至关键症状恶化的时间长于化疗组，且更高比例的患者总体健康状况/生活质量得到改善，这表明奥希替尼改善了患者的预后。
PurposeCapturing patient-reported outcome data is important for evaluating the overall clinical benefits of new cancer therapeutics. We assessed self-reported symptoms of advanced non-small-cell lung cancer in patients treated with osimertinib or chemotherapy in the AURA3 phase III trial.Patients and MethodsPatients completed the European Organisation for Research and Treatment of Cancer 13-item Quality of Life Questionnaire-Lung Cancer Module (EORTC QLQ-LC13) questionnaire on disease-specific symptoms and the EORTC 30-item Core Quality of Life Questionnaire (EORTC QLC-C30) on general cancer symptoms, functioning, global health status/quality of life. We assessed differences between treatments in time to deterioration of individual symptoms and odds of improvement (a deterioration or improvement was defined as a change in score from baseline of 10). Hazard ratios (HRs) were calculated using a log-rank test stratified by ethnicity; odds ratios (ORs) were assessed using logistic regression adjusted for ethnicity.ResultsAt baseline, the questionnaires were completed by 82% to 88% of patients, and 30% to 70% had individual key symptoms. Time to deterioration was longer with osimertinib than with chemotherapy for cough (HR, 0.74; 95% CI, 0.53 to 1.05), chest pain (HR, 0.52; 95% CI, 0.37 to 0.73), and dyspnea (HR, 0.42; 95% CI, 0.31 to 0.58). The proportion of symptomatic patients with improvement in global health status/quality of life was higher with osimertinib (80 [37%] of 215) than with chemotherapy (23 [22%] of 105; OR, 2.11; 95% CI, 1.24 to 3.67; P = .007). Proportions were also higher for appetite loss (OR, 2.50; 95% CI, 1.31 to 4.84) and fatigue (OR, 1.96; 95% CI, 1.20 to 3.22).ConclusionTime to deterioration of key symptoms was longer with osimertinib than with chemotherapy, and a higher proportion of patients had improvement in global health status/quality of life, demonstrating improved patient outcomes with osimertinib.