FURLONG 研究中，与吉非替尼一线治疗表皮生长因子受体 (EGFR) 突变阳性非小细胞肺癌 (NSCLC) 患者相比，富莫替尼 (Furmonertinib) 表现出优越的疗效。在此，我们提出患者报告结果 (PRO) 的预先指定的次要终点。在这项多中心、双盲、双模拟、随机 3 期研究中，患者按 1:1 随机分配接受 80 毫克每日一次的呋莫替尼或 250 毫克吉非替尼治疗每天一次。使用重复测量和事件发生时间分析的混合模型对欧洲癌症研究和治疗组织生活质量问卷核心 30 和肺癌生活质量问卷 13 评估的 PRO 进行了分析。分数差异 10 分或以上被认为具有临床相关性。 三百五十七名患者（呋莫替尼组，n = 178；吉非替尼组，n = 179）接受了至少一剂研究药物，全部完成至少一项 PRO 评估。总体评分变化与基线相比在身体机能方面有统计学显着性差异（组间差异 2.14 [95% CI 0.25-4.04]，p = 0.027）、恶心/呕吐（-1.56 [95% CI -2.62 至 -0.49] ，p = 0.004）、食欲不振（-2.24 [95% CI -4.26 至 -0.23]，p = 0.029）、腹泻（-3.36 [95% CI -5.19 至 -1.54]，p < 0.001）、脱发（- 2.62 [95% CI -4.54 至 -0.71]，p = 0.007），其他部位疼痛（-4.55 [95% CI -7.37 至 -1.74]，p = 0.002），但未达到临床相关性。身体功能恶化的时间（风险比 0.63 [95% CI 0.42-0.94]，p = 0.021）、认知功能（0.73 [95% CI 0.54-0.98]，p = 0.034）、恶心/呕吐（0.64 [95% CI 0.41-0.99]，p = 0.042），食欲不振（0.63 [95% CI 0.43-0.92]，p = 0.016），腹泻（0.63 [95% CI 0.46-0.85]，p = 0.002），呼吸困难（0.72 [ 95% CI 0.53-0.98]，p = 0.034）、咳嗽（0.67 [95% CI 0.44-1.00]，p = 0.049）、吞咽困难（0.54 [95% CI 0.35-0.83]，p = 0.004）和脱发（ 0.62 [95% CI 0.42-0.90]，p = 0.012）与吉非替尼相比，呋莫替尼的时间更长。在局部晚期或转移性 EGFR 突变阳性 NSCLC 患者中，与吉非替尼相比，呋莫替尼在多种功能和症状方面表现出评分改善和延迟恶化。上海艾利斯特医药科技有限公司及国家重点新药创制科技重大专项（2017ZX09304015）。© 2024 作者。

Furmonertinib showed superior efficacy compared with gefitinib as first-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 prespecified secondary endpoints of patient-reported outcomes (PRO).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 gefitinib 250 mg once daily. PROs assessed by the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 and Quality-of-Life 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.Three hundred and fifty-seven patients (furmonertinib group, n = 178; gefitinib group, n = 179) received at least one dose of the study drug, all of whom completed at least one PRO assessment. Statistically significant 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 gefitinib.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 gefitinib.Shanghai Allist Pharmaceutical Technology Co., Ltd and the National Science and Technology Major Project for Key New Drug Development (2017ZX09304015).© 2024 The Authors.