首页|帕博利珠单抗治疗晚期非小细胞肺癌安全性和有效性的真实世界研究

帕博利珠单抗治疗晚期非小细胞肺癌安全性和有效性的真实世界研究

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背景与目的 帕博利珠单抗(Pembrolizumab,PEM)治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)在临床试验中被证实有效,但这些试验是基于按照特定标准筛选的患者群体,因此这些结果是否能够代表真实世界中患者的普遍情况,仍然值得讨论.本研究旨在基于真实世界数据评估PEM治疗晚期NSCLC的有效性和安全性.方法 回顾性收集接受PEM治疗的晚期NSCLC患者的真实世界数据,使用倾向性评分匹配消除组间差异,评估PEM与化疗的有效性和安全性.结果 在倾向性评分匹配后的450例患者中PEM组和化疗组任何等级不良事件发生率分别为79.87%和86.71%,≥3级不良事件发生率分别为4.03%和7.31%.PEM组和化疗组的客观缓解率分别为48.63%和36.00%(P=0.011),中位无进展生存期分别为15.5和8.8个月(P<0.001),中位总生存期分别为未达到和26.2个月(P<0.001).结论 PEM治疗晚期NSCLC在实际临床应用中显示出较好的生存率和可接受的安全性.
Real-world Study of the Safety and Efficacy of Pembrolizumab in the Treatment of Advanced Non-small Cell Lung Cancer
Background and objective Pembrolizumab(PEM)has been shown to be effective in clinical trials for the treatment of advanced non-small cell lung cancer(NSCLC),but clinical trials were based on cohorts of patients selected on specific criteria,and whether the findings are consistent with real-world patients is debatable.The aim of this study is to evaluate the efficacy and safety of PEM in the treatment of advanced NSCLC based on real-world data.Methods A retro-spective collection of real-world data from patients with advanced NSCLC receiving PEM was conducted.Propensity score matching was used to eliminate inter-group differences and assess the efficacy and safety of PEM compared to chemotherapy.Results Among 450 matched patients,the incidence rates of any-grade adverse events were 79.87%in the PEM group and86.71%inthe chemotherapy group,while the incidence rates of grade>3 adverse events were 4.03%and 7.31%,respectively.The objective response rates were 48.63%for PEM and 36.00%for chemotherapy(P=0.011).The median progression-free survival was 15.5 months for PEM and 8.8 months for chemotherapy(P<0.001),and the median overall survival was not reached for PEM and 26.2 months for chemotherapy(P<0.001).Conclusion PEM treatment for advanced NSCLC demonstrates favorable survival outcomes and acceptable safety in real-world clinical practice.

Real-world dataPembrolizumabLung neoplasmsSafetyEfficacy

万宁、王冰、郭娅、何梓健、杨晨、杨宁、卢丽清、梁虹艺、萧伟斌、杨丹丹、陈卓佳、方文峰、梁蔚婷

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510010 广州,中国人民解放军南部战区总医院临床药学科

510515 广州,南方医科大学药学院

510006 广州,广州中医药大学药学院

528306 佛山,佛山市顺德区和祜医院药学部

510623 广州,暨南大学药学院

510010 广州,中国人民解放军南部战区总医院肿瘤科

510120 广州,中山大学孙逸仙纪念医院药学部

510060 广州,中山大学肿瘤防治中心药学部,华南恶性肿瘤防治全国重点实验室,广东省恶性肿瘤临床医学研究中心

510060 广州,中山大学肿瘤防治中心内科,华南恶性肿瘤防治全国重点实验室,广东省恶性肿瘤临床医学研究中心

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真实世界数据 帕博利珠单抗 肺肿瘤 安全性 有效性

2024

中国肺癌杂志
中国抗癌协会 中国防痨协会 天津医科大学总医院

中国肺癌杂志

CSTPCD北大核心
影响因子:1.397
ISSN:1009-3419
年,卷(期):2024.27(10)