Patient-Reported Symptoms and Impact of Treatment With Osimertinib Versus Chemotherapy in Advanced Non-Small-Cell Lung Cancer: The AURA3 Trial

被引:28
|
作者
Lee, Chee Khoon [1 ]
Novello, Silvia [2 ]
Ryden, Anna [3 ]
Mann, Helen [4 ]
Mok, Tony [5 ]
机构
[1] St George Hosp, Kogarah, NSW, Australia
[2] Univ Turin, Turin, Italy
[3] AstraZeneca Gothenburg, Molndal, Sweden
[4] AstraZeneca R&D, Cambridge, England
[5] Chinese Univ Hong Kong, Prince Wales Hosp, Hong Kong, Hong Kong, Peoples R China
关键词
QUALITY-OF-LIFE; MINIMAL IMPORTANT DIFFERENCES; EORTC QLQ-C30; EUROPEAN-ORGANIZATION; 1ST-LINE TREATMENT; OPEN-LABEL; PHASE-III; EGFR-TKI; T790M MUTATION; CLINICAL-TRIAL;
D O I
10.1200/JCO.2017.77.2293
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
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页码:1853 / +
页数:14
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