PDF(Pubmed)
Abstract：
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Shanghai Allist Pharmaceutical Technology Co., Ltd and the National Science and Technology Major Project for Key New Drug Development (2017ZX09304015).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: Shanghai Allist Pharmaceutical Technology Co., Ltd and the National Science and Technology Major Project for Key New Drug Development (2017ZX09304015).
摘要：
■在FURLONG研究中，与吉非替尼相比，Furmonertinib作为表皮生长因子受体（EGFR）突变阳性非小细胞肺癌（NSCLC）患者的一线治疗具有更好的疗效。在这里，我们介绍了患者报告结果(PRO)的预设次要终点。
■在这个多中心，双盲,双假人,随机3期研究，患者被1:1随机分配至接受furmonertinib80mg,每日1次或吉非替尼250mg,每日1次.欧洲癌症研究和治疗组织核心生活质量问卷30和生活质量问卷13评估的PROs使用混合模型进行重复测量和事件时间分析。10分或更多的评分差异被认为是临床相关的。
■三百五十七名患者（furmonertinib组，n=178；吉非替尼组，n=179)接受至少一个剂量的研究药物,所有这些人都完成了至少一项PRO评估。与基线相比，总分变化的统计学差异有利于furmonertinib的身体功能（组间差异2.14[95％CI0.25-4.04]，p=0.027),恶心/呕吐（-1.56[95%CI-2.62至-0.49]，p=0.004),食欲减退（-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(危险比0.63[95%CI0.42-0.94]，p=0.021),认知功能（0.73[95%CI0.54-0.98]，p=0.034),恶心/呕吐（0.64[95%CI0.41-0.99]，p=0.042),食欲减退（0.63[95%CI0.43-0.92]，p=0.016),腹泻（0.63[95%CI0.46-0.85]，p=0.002),呼吸困难（0.72[95%CI0.53-0.98]，p=0.034),咳嗽（0.67[95%CI0.44-1.00]，p=0.049),吞咽困难（0.54[95%CI0.35-0.83]，p=0.004),和脱发（0.62[95%CI0.42-0.90]，p=0.012）与吉非替尼相比，使用furmonertinib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,furmonertinib在多项功能和症状方面得分改善,并延迟恶化.
■上海Allist医药科技有限公司有限公司和国家重点新药开发科技重大专项（2017ZX09304015）。
■在这个多中心，双盲,双假人,随机3期研究，患者被1:1随机分配至接受furmonertinib80mg,每日1次或吉非替尼250mg,每日1次.欧洲癌症研究和治疗组织核心生活质量问卷30和生活质量问卷13评估的PROs使用混合模型进行重复测量和事件时间分析。10分或更多的评分差异被认为是临床相关的。
■三百五十七名患者（furmonertinib组，n=178；吉非替尼组，n=179)接受至少一个剂量的研究药物,所有这些人都完成了至少一项PRO评估。与基线相比，总分变化的统计学差异有利于furmonertinib的身体功能（组间差异2.14[95％CI0.25-4.04]，p=0.027),恶心/呕吐（-1.56[95%CI-2.62至-0.49]，p=0.004),食欲减退（-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(危险比0.63[95%CI0.42-0.94]，p=0.021),认知功能（0.73[95%CI0.54-0.98]，p=0.034),恶心/呕吐（0.64[95%CI0.41-0.99]，p=0.042),食欲减退（0.63[95%CI0.43-0.92]，p=0.016),腹泻（0.63[95%CI0.46-0.85]，p=0.002),呼吸困难（0.72[95%CI0.53-0.98]，p=0.034),咳嗽（0.67[95%CI0.44-1.00]，p=0.049),吞咽困难（0.54[95%CI0.35-0.83]，p=0.004),和脱发（0.62[95%CI0.42-0.90]，p=0.012）与吉非替尼相比，使用furmonertinib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,furmonertinib在多项功能和症状方面得分改善,并延迟恶化.
■上海Allist医药科技有限公司有限公司和国家重点新药开发科技重大专项（2017ZX09304015）。
