Article(id=1291404811203768383, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1291404791758975909, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2025.11.004, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1734883200000, receivedDateStr=2024-12-23, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785824500132, onlineDateStr=2026-08-04, pubDate=1750089600000, pubDateStr=2025-06-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785824500132, onlineIssueDateStr=2026-08-04, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785824500132, creator=13701087609, updateTime=1785824500132, updator=13701087609, issue=Issue{id=1291404791758975909, tenantId=1146029695717560320, journalId=1246415772164075586, year='2025', volume='41', issue='11', pageStart='1501', pageEnd='1650', issueExtLink='null', onlineDate='null', pubDate='1750089600000', pubDateStr='2025-06-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785824495496, creator='13701087609', updateTime=1785824495496, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext=null, issueFiles=null, downloadFileDto=null}, startPage=1517, endPage=1521, ext={EN=ArticleExt(id=1291404811426066496, articleId=1291404811203768383, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of tiragolumab in the treatment of patients with advanced non-small cell lung cancer harboring EGFR mutations and resistance to targeted therapy, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
Objective

To observe the clinical efficacy and safety of tislelizumab injection in the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations and resistance to targeted therapy.

Methods

Patients with advanced NSCLC and EGFR mutations were assigned to control group and treatment group. The control group received 500 mg·m-2 pemetrexed disodium for injection by intravenous infusion on the first day + 7.5 mg·kg-1 bevacizumab injection by intravenous infusion every 3 weeks + 80 mg·m-2 nedaplatin by intravenous infusion on the first day. On the basis of control group, the treatment group received 200 mg tislelizumab injection by intravenous infusion every 3 weeks. Two groups were treated for 3 cycles with 3 weeks per cycle. The clinical efficacy, tumor markers, quality of life and safety were compared between two groups.

Results

Treatment group was enrolled 51 cases; control group was enrolled 51 cases. After treatment, the overall effective rates of treatment and control groups were 54.90% (28 cases / 51 cases) and 21.57% (11 cases / 51 cases), with statistically significant difference (P<0.01). After treatment, the levels of carcinoembryonic antigen (CEA) in treatment and control groups were (6.67±1.24) and (11.58±1.36) ng·mL-1; the levels of cytokeratin-19 fragments were (7.64±1.47) and (12.25±1.63) ng·mL-1; the levels of neuron-specific enolase were (22.65±2.81) and (25.05±2.94) ng·mL-1; the quality of life scores were (73.67±6.24) and (64.45±5.36) points; the median progression-free survival were 7.00 and 10.00 months; the median overall survival were 14.00 and 20.00 months, respectively. The differences of above indexes were statistically significant between two groups (all P<0.05). The adverse drug reactions of two groups were nausea and vomiting, liver function impairment and renal function impairment. The incidences of total adverse drug reactions in treatment and control groups were 27.45% (14 cases/51 cases) and 31.37% (16 cases/51 cases), without statistically significant difference (P>0.05).

Conclusion

Tislelizumab injection has a definitive clinical efficacy in the treatment of patients with advanced NSCLC harboring EGFR mutations and resistance to targeted therapy, which can reduce the tumor marker levels, improve the quality of life, with high safety.

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目的

观察替雷利珠单抗注射液治疗表皮生长因子受体(EGFR)基因突变晚期非小细胞肺癌(NSCLC)靶向治疗后耐药患者的临床疗效和安全性。

方法

EGFR突变晚期NSCLC患者分为对照组和试验组。对照组给予500 mg·m-2注射用培美曲塞二钠,静脉滴注,第1天+7.5 mg·kg-1·d-1贝伐珠单抗注射液,静脉滴注,每3周1次+80 mg·m-2注射用奈达铂,静脉滴注,第1天;试验组在对照组治疗的基础上,联合替雷利珠单抗注射液每次200 mg,静脉滴注,每3周给药1次。2组患者均治疗3个疗程,每个疗程3周。比较2组患者的临床疗效、肿瘤标志物、生命质量,以及安全性。

结果

试验组入组51例,对照组入组51例。治疗后,试验组和对照组的总有效率分别为54.90%(28例/51例)和21.57%(11例/51例),在统计学上差异有统计学意义(P<0.01)。治疗后,试验组和对照组的癌胚抗原水平分别为(6.67±1.24)和(11.58±1.36)ng·mL-1,细胞角蛋白19片段水平分别为(7.64±1.47)和(12.25±1.63)ng·mL-1,神经元特异性烯醇化酶水平分别为(22.65±2.81)和(25.05±2.94)ng·mL-1,生命质量测定量表评分分别为(73.67±6.24)和(64.45±5.36)分,中位无进展生存期分别为7.00和10.00个月,中位总生存时间分别为14.00和20.00个月,在统计学上差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以恶心呕吐、肝功能损害、肾功能损害为主。试验组和对照组的总药物不良反应发生率分别为27.45%(14例/51例)和31.37%(16例/51例),在统计学上差异无统计学意义(P>0.05)。

结论

替雷利珠单抗注射液治疗EGFR突变晚期NSCLC靶向治疗后耐药患者的临床疗效显著,其能有效降低患者的肿瘤标志物水平,提高患者的生活质量,且安全性较高。

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王永强(1975-),男,副主任医师,主要从事呼吸与危重症医学的临床诊疗工作

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王永强 MP: 15908537582 E-mail:
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替雷利珠单抗治疗EGFR突变晚期非小细胞肺癌靶向治疗后耐药患者的临床研究
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王永强 1a , 谭博飞 1a , 朱跃 1b
中国临床药理学杂志 | 临床与基础桥接研究 2025,41(11): 1517-1521
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中国临床药理学杂志 |临床与基础桥接研究 2025 , 41 (11) : 1517 -1521
替雷利珠单抗治疗EGFR突变晚期非小细胞肺癌靶向治疗后耐药患者的临床研究
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王永强1a , 谭博飞1a, 朱跃1b
作者信息
  • 1a.中国贵航集团三〇二医院,呼吸与危重症医学科,贵州 安顺 561000
  • 1b.中国贵航集团三〇二医院,肿瘤科,贵州 安顺 561000
通讯作者:
王永强 MP: 15908537582 E-mail:
作者简介:

王永强(1975-),男,副主任医师,主要从事呼吸与危重症医学的临床诊疗工作

Clinical trial of tiragolumab in the treatment of patients with advanced non-small cell lung cancer harboring EGFR mutations and resistance to targeted therapy
Yong-qiang WANG1a , Bo-fei TAN1a, Yue ZHU1b
Affiliations
  • 1a.Department of Respiratory and Critical Care Medicine, 302 Hospital of Guihang Group, Anshun 561000, Guizhou Province, China
  • 1b.Department of Oncology, 302 Hospital of Guihang Group, Anshun 561000, Guizhou Province, China
出版时间: 2025-06-17 doi: 10.13699/j.cnki.1001-6821.2025.11.004
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目的

观察替雷利珠单抗注射液治疗表皮生长因子受体(EGFR)基因突变晚期非小细胞肺癌(NSCLC)靶向治疗后耐药患者的临床疗效和安全性。

方法

EGFR突变晚期NSCLC患者分为对照组和试验组。对照组给予500 mg·m-2注射用培美曲塞二钠,静脉滴注,第1天+7.5 mg·kg-1·d-1贝伐珠单抗注射液,静脉滴注,每3周1次+80 mg·m-2注射用奈达铂,静脉滴注,第1天;试验组在对照组治疗的基础上,联合替雷利珠单抗注射液每次200 mg,静脉滴注,每3周给药1次。2组患者均治疗3个疗程,每个疗程3周。比较2组患者的临床疗效、肿瘤标志物、生命质量,以及安全性。

结果

试验组入组51例,对照组入组51例。治疗后,试验组和对照组的总有效率分别为54.90%(28例/51例)和21.57%(11例/51例),在统计学上差异有统计学意义(P<0.01)。治疗后,试验组和对照组的癌胚抗原水平分别为(6.67±1.24)和(11.58±1.36)ng·mL-1,细胞角蛋白19片段水平分别为(7.64±1.47)和(12.25±1.63)ng·mL-1,神经元特异性烯醇化酶水平分别为(22.65±2.81)和(25.05±2.94)ng·mL-1,生命质量测定量表评分分别为(73.67±6.24)和(64.45±5.36)分,中位无进展生存期分别为7.00和10.00个月,中位总生存时间分别为14.00和20.00个月,在统计学上差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以恶心呕吐、肝功能损害、肾功能损害为主。试验组和对照组的总药物不良反应发生率分别为27.45%(14例/51例)和31.37%(16例/51例),在统计学上差异无统计学意义(P>0.05)。

结论

替雷利珠单抗注射液治疗EGFR突变晚期NSCLC靶向治疗后耐药患者的临床疗效显著,其能有效降低患者的肿瘤标志物水平,提高患者的生活质量,且安全性较高。

替雷利珠单抗注射液  /  非小细胞肺癌  /  表皮生长因子受体突变  /  耐药  /  临床疗效  /  安全性评价
Objective

To observe the clinical efficacy and safety of tislelizumab injection in the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) mutations and resistance to targeted therapy.

Methods

Patients with advanced NSCLC and EGFR mutations were assigned to control group and treatment group. The control group received 500 mg·m-2 pemetrexed disodium for injection by intravenous infusion on the first day + 7.5 mg·kg-1 bevacizumab injection by intravenous infusion every 3 weeks + 80 mg·m-2 nedaplatin by intravenous infusion on the first day. On the basis of control group, the treatment group received 200 mg tislelizumab injection by intravenous infusion every 3 weeks. Two groups were treated for 3 cycles with 3 weeks per cycle. The clinical efficacy, tumor markers, quality of life and safety were compared between two groups.

Results

Treatment group was enrolled 51 cases; control group was enrolled 51 cases. After treatment, the overall effective rates of treatment and control groups were 54.90% (28 cases / 51 cases) and 21.57% (11 cases / 51 cases), with statistically significant difference (P<0.01). After treatment, the levels of carcinoembryonic antigen (CEA) in treatment and control groups were (6.67±1.24) and (11.58±1.36) ng·mL-1; the levels of cytokeratin-19 fragments were (7.64±1.47) and (12.25±1.63) ng·mL-1; the levels of neuron-specific enolase were (22.65±2.81) and (25.05±2.94) ng·mL-1; the quality of life scores were (73.67±6.24) and (64.45±5.36) points; the median progression-free survival were 7.00 and 10.00 months; the median overall survival were 14.00 and 20.00 months, respectively. The differences of above indexes were statistically significant between two groups (all P<0.05). The adverse drug reactions of two groups were nausea and vomiting, liver function impairment and renal function impairment. The incidences of total adverse drug reactions in treatment and control groups were 27.45% (14 cases/51 cases) and 31.37% (16 cases/51 cases), without statistically significant difference (P>0.05).

Conclusion

Tislelizumab injection has a definitive clinical efficacy in the treatment of patients with advanced NSCLC harboring EGFR mutations and resistance to targeted therapy, which can reduce the tumor marker levels, improve the quality of life, with high safety.

tislelizumab injection  /  non-small cell lung cancer  /  epidermal growth factor receptor mutation  /  resistance  /  clinical efficacy  /  safety evaluation
王永强, 谭博飞, 朱跃. 替雷利珠单抗治疗EGFR突变晚期非小细胞肺癌靶向治疗后耐药患者的临床研究. 中国临床药理学杂志, 2025 , 41 (11) : 1517 -1521 . DOI: 10.13699/j.cnki.1001-6821.2025.11.004
Yong-qiang WANG, Bo-fei TAN, Yue ZHU. Clinical trial of tiragolumab in the treatment of patients with advanced non-small cell lung cancer harboring EGFR mutations and resistance to targeted therapy[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (11) : 1517 -1521 . DOI: 10.13699/j.cnki.1001-6821.2025.11.004
  • 贵州省卫生健康委科学技术基金资助项目(gzwkj2023-018)
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2025年第41卷第11期
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doi: 10.13699/j.cnki.1001-6821.2025.11.004
  • 接收时间:2024-12-23
  • 首发时间:2026-08-04
  • 出版时间:2025-06-17
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  • 收稿日期:2024-12-23
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贵州省卫生健康委科学技术基金资助项目(gzwkj2023-018)
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    1a.中国贵航集团三〇二医院,呼吸与危重症医学科,贵州 安顺 561000
    1b.中国贵航集团三〇二医院,肿瘤科,贵州 安顺 561000

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王永强 MP: 15908537582 E-mail:
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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