Patient-reported outcomes for the phase 3 FURLONG study of furmonertinib versus ge fi tinib as fi rst-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer
Background Furmonertinib showed superior ef fi cacy compared with ge fi tinib as fi rst -line therapy in patients with epidermal growth factor receptor ( EGFR ) mutation -positive non -small cell lung cancer (NSCLC) in the FURLONG study. Here we present prespeci fi ed secondary endpoints of patient -reported outcomes (PRO). Methods In this multicentre, double-blind, double -dummy, randomised phase 3 study, patients were 1:1 randomly assigned to receive furmonertinib 80 mg once daily or ge fi tinib 250 mg once daily. PROs assessed by the European Organization for Research and Treatment of Cancer Quality -of -Life Questionnaire Core 30 and Quality -ofLife Questionnaire Lung Cancer 13 were analysed using a mixed model for repeated measures and time -to -event analyses. A difference in score of 10 points or more was deemed clinically relevant. Findings Three hundred and fi fty-seven patients (furmonertinib group, n = 178; ge fi tinib group, n = 179) received at least one dose of the study drug, all of whom completed at least one PRO assessment. Statistically signi fi cant difference of overall score changes from baseline favoured furmonertinib in physical functioning (between -group difference 2.14 [95% CI 0.25 - 4.04], p = 0.027), nausea/vomiting ( - 1.56 [95% CI - 2.62 to - 0.49], p = 0.004), appetite loss ( - 2.24 [95% CI - 4.26 to - 0.23], p = 0.029), diarrhoea ( - 3.36 [95% CI - 5.19 to - 1.54], p < 0.001), alopecia ( - 2.62 [95% CI - 4.54 to - 0.71], p = 0.007), and pain in other parts ( - 4.55 [95% CI - 7.37 to - 1.74], p = 0.002), but not reached clinical relevance. Time to deterioration in physical functioning (hazard ratio 0.63 [95% CI 0.42 - 0.94], p = 0.021), cognitive functioning (0.73 [95% CI 0.54 - 0.98 ], p = 0.034), nausea/vomiting (0.64 [95% CI 0.41 - 0.99], p = 0.042), appetite loss (0.63 [95% CI 0.43 - 0.92], p = 0.016), diarrhoea (0.63 [95% CI 0.46 - 0.85], p = 0.002), dyspnoea (0.72 [95% CI 0.53 - 0.98], p = 0.034), cough (0.67 [95% CI 0.44 - 1.00], p = 0.049), dysphagia (0.54 [95% CI 0.35 - 0.83], p = 0.004), and alopecia (0.62 [95% CI 0.42 - 0.90], p = 0.012) was longer with furmonertinib versus ge fi tinib. Interpretation In patients with locally advanced or metastatic EGFR mutation -positive NSCLC, furmonertinib showed improved scores and delayed deterioration in several functioning and symptoms compared to ge fi tinib.
基金：
National Science and Technology Major Project for Key New Drug Development [2017ZX09304015]
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外文
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出版当年[2025]版：
无
最新[2025]版：
大类|1 区医学
小类|1 区卫生保健与服务1 区公共卫生、环境卫生与职业卫生
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出版当年[2024]版：
无
最新[2023]版：
Q1HEALTH CARE SCIENCES & SERVICESQ1PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH
第一作者机构：[1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Clin Res Ctr Canc, Dept Med Oncol,Beijing Key Lab Clin Study Anticanc, Beijing 100021, Peoples R China
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推荐引用方式(GB/T 7714)：
Shi Yuankai,Chen Gongyan,Wang Xiang,et al.Patient-reported outcomes for the phase 3 FURLONG study of furmonertinib versus ge fi tinib as fi rst-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer[J].LANCET REGIONAL HEALTH-WESTERN PACIFIC.2024,48:doi:10.1016/j.lanwpc.2024.101122.
APA：
Shi, Yuankai,Chen, Gongyan,Wang, Xiang,Liu, Yunpeng,Wu, Lin...&Ge, Nan.(2024).Patient-reported outcomes for the phase 3 FURLONG study of furmonertinib versus ge fi tinib as fi rst-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer.LANCET REGIONAL HEALTH-WESTERN PACIFIC,48,
MLA：
Shi, Yuankai,et al."Patient-reported outcomes for the phase 3 FURLONG study of furmonertinib versus ge fi tinib as fi rst-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small cell lung cancer".LANCET REGIONAL HEALTH-WESTERN PACIFIC 48.(2024)
医学