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1.云南省第一人民医院/昆明理工大学附属昆华医院药学部,昆明 650032
2.大理大学药学院,云南 大理 671000
3.昆明医科大学药学院,昆明 650500
药师,硕士研究生。研究方向:临床药学。E-mail:1853153557@qq.com
主任药师,硕士生导师,硕士。研究方向:医院药学、临床药学。E-mail:tuwenlian18@aliyun.com
收稿:2025-07-30,
修回:2025-09-15,
录用:2025-12-01,
纸质出版:2025-12-30
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潘燕,杨升锡,刘嘉欣,等.替雷利珠单抗与信迪利单抗治疗晚期NSCLC的效果比较及影响因素分析 Δ[J].中国药房,2025,36(24):3096-3101.
PAN Yan,YANG Shengxi,LIU Jiaxin,et al.Comparison of efficacy and influential factors between tislelizumab and sintilimab in the treatment of advanced NSCLC[J].ZHONGGUO YAOFANG,2025,36(24):3096-3101.
潘燕,杨升锡,刘嘉欣,等.替雷利珠单抗与信迪利单抗治疗晚期NSCLC的效果比较及影响因素分析 Δ[J].中国药房,2025,36(24):3096-3101. DOI: 10.6039/j.issn.1001-0408.2025.24.14.
PAN Yan,YANG Shengxi,LIU Jiaxin,et al.Comparison of efficacy and influential factors between tislelizumab and sintilimab in the treatment of advanced NSCLC[J].ZHONGGUO YAOFANG,2025,36(24):3096-3101. DOI: 10.6039/j.issn.1001-0408.2025.24.14.
目的
2
比较替雷利珠单抗与信迪利单抗分别联合化疗用于晚期非小细胞肺癌(NSCLC)患者的疗效及安全性,并分析其预后影响因素。
方法
2
回顾性收集2021年9月1日至2024年11月30日于云南省第一人民医院接受替雷利珠单抗与信迪利单抗联合化疗的晚期NSCLC患者163例,其中替雷利珠单抗组共90例,信迪利单抗组共73例。观察两组患者的客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS),评估患者不良反应发生情况。采用Kaplan-Meier法绘制PFS和OS生存曲线,应用Log-rank检验进行单因素分析,并采用Cox回归模型评估PFS和OS的独立预后影响因素。
结果
2
替雷利珠单抗组与信迪利单抗组患者的中位PFS分别为14.14个月(95%CI为10.95~17.33)和10.95个月(95%CI为8.75~13.15),中位OS分别为25.89个月(95%CI为22.67~29.11)和24.25个月(95%CI为19.34~29.16),ORR分别为45.56%和49.32%,DCR分别为94.44%和90.41%,不良反应发生率分别为84.44%和79.45%,差异均无统计学意义(
P
>0.05)。年龄≥60岁(HR=1.542,95%CI为1.044~2.278,
P
=0.029)、系统免疫炎症营养指数(SIINI)>116.58(HR=1.541,95%CI为1.058~2.245,
P
=0.024)是影响接受免疫检查点抑制剂治疗NSCLC患者PFS的危险因素;使用抗菌药物可能会影响患者的OS(
P
=0.001)。
结论
2
替雷利珠单抗与信迪利单抗分别联合化疗用于晚期NSCLC的疗效及安全性相当;年龄≥60岁及SIINI>116.58是影响NSCLC患者PFS的危险因素,使用抗菌药物可能会影响患者的OS。
OBJECTIVE
2
To compare the efficacy and safety of chemotherapy combined with tislelizumab or sintilimab in patients with advanced non-small cell lung cancer (NSCLC), and to analyze the influential factors of prognostic.
METHODS
2
A retrospective study was conducted on 163 patients with advanced NSCLC who received chemotherapy combined with tislelizumab or sintilimab at the First People’s Hospital of Yunnan Province from September 1, 2021 to November 30, 2024. Among them, there were 90 patients in the tislelizumab group and 73 patients in the sintilimab group. The objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), and overall survival (OS) of two groups were observed, and the occurrence of adverse drug reactions in patients was evaluated. Kaplan-Meier method was used to plot PFS and OS survival curves, Log-rank test was applied for univariate analysis, and Cox regression model was used to evaluate the independent prognostic factors of PFS and OS.
RESULTS
2
The median PFS of patients in the tislelizumab group and the sintilimab group were 14.14 months (95%CI of 10.95-17.33) and 10.95 mo
nths (95%CI of 8.75-13.15), respectively. The median OS was 25.89 months (95%CI of 22.67-29.11) and 24.25 months (95%CI of 19.34-29.16), with ORR of 45.56% and 49.32%, DCR of 94.44% and 90.41%, and the incidence of adverse drug reactions of 84.44% and 79.45%, respectively, the differences were not statistically significant (
P
>0.05). Age≥60 years (HR=1.542, 95%CI of 1.044-2.278,
P
=0.029) and systemic immune inflammatory nutritional index (SIINI)>116.58 (HR=1.541, 95%CI of 1.058-2.245,
P
=0.024) were risk factors for PFS in NSCLC patients receiving immune checkpoint inhibitor therapy; the use of antibiotics may affect the overall survival of patients (
P
=0.001).
CONCLUSIONS
2
The efficacy and safety of chemotherapy combined with tislelizumab or sintilimab for advanced NSCLC are comparable; age≥60 years and SIINI
>116.58 are risk factors for PFS in NSCLC patients, and the use of antibiotics may affect the patients’ OS.
CHEN P X , LIU Y H , WEN Y K , et al . Non-small cell lung cancer in China [J ] . Cancer Commun (Lond) , 2022 , 42 ( 10 ): 937 - 970 .
陈香梅 , 刘太锋 , 杨明 , 等 . 不同免疫检查点抑制剂联合化疗治疗非小细胞肺癌的疗效及对肿瘤标志物水平的影响 [J ] . 中国肿瘤临床与康复 , 2022 , 29 ( 7 ): 774 - 778 .
中国临床肿瘤学会指南工作委员会 . 中国临床肿瘤学会(CSCO)非小细胞肺癌诊疗指南2025 [M ] . 北京 : 人民卫生出版社 , 2025 : 173 - 190 .
GARASSINO M C , GADGEEL S , SPERANZA G , et al . Pembrolizumab plus pemetrexed and platinum in nonsquamous non-small-cell lung cancer:5-year outcomes from the phase 3 KEYNOTE-189 study [J ] . J Clin Oncol , 2023 , 41 ( 11 ): 1992 - 1998 .
LU S , FANG J , WANG Z P , et al . Results from the IMpower132 China cohort:atezolizumab plus platinum-based chemotherapy in advanced non-small cell lung cancer [J ] . Cancer Med , 2023 , 12 ( 3 ): 2666 - 2676 .
刘淑娟 , 郝亚洁 . 替雷利珠单抗联合安罗替尼治疗晚期非鳞状非小细胞肺癌的临床效果 [J ] . 河南医学研究 , 2023 , 32 ( 6 ): 1102 - 1105 .
ZHOU F , QIAO M , ZHOU C C . The cutting-edge pro-gress of immune-checkpoint blockade in lung cancer [J ] . Cell Mol Immunol , 2021 , 18 ( 2 ): 279 - 293 .
D′CRUZ A , FEY M , POLLOCK R E , et al . UICC manual of clinical oncology [M ] . 9th edition . Oxford : Wiley-Blackwell , 2015 : 205 - 220 .
中国临床肿瘤学会指南工作委员会组织 . 中国临床肿瘤学会(CSCO)免疫检查点抑制剂相关的毒性管理指南2023 [M ] . 北京 : 人民卫生出版社 , 2023 : 31-60,106-120 .
ZHOU C C , HUANG D Z , FAN Y , et al . Tislelizumab versus docetaxel in patients with previously treated advanced NSCLC (RATIONALE-303):a phase 3,open-label,randomized controlled trial [J ] . J Thorac Oncol , 2023 , 18 ( 1 ): 93 - 105 .
LU S , WANG J , YU Y , et al . Tislelizumab plus chemotherapy as first-line treatment of locally advanced or metastatic nonsquamous non-small-cell lung cancer (final analysis of RATIONALE-304:a randomized phase Ⅲ trial) [J ] . ESMO Open , 2024 , 9 ( 10 ): 103728 .
WANG J , LU S , YU X , et al . Tislelizumab plus chemotherapy versus chemotherapy alone as first-line treatment for advanced squamous non-small-cell lung cancer:final analysis of the randomized,phase Ⅲ RATIONALE-307 trial [J ] . ESMO Open , 2024 , 9 ( 10 ): 103727 .
ZHANG L , WANG Z H , FANG J , et al . Final overall survival data of sintilimab plus pemetrexed and platinum as first-line treatment for locally advanced or metastatic nonsquamous NSCLC in the phase 3 ORIENT-11 study [J ] . Lung Cancer , 2022 , 171 : 56 - 60 .
ZHOU C C , WU L , FAN Y , et al . Sintilimab plus platinum and gemcitabine as first-line treatment for advanced or metastatic squamous NSCLC:results from a random-ized,double-blind,phase 3 trial (ORIENT-12) [J ] . J Thorac Oncol , 2021 , 16 ( 9 ): 1501 - 1511 .
MONTRONE M , ROSATI G , LONGO V , et al . Immunotherapy in elderly patients affected by non-small cell lung cancer:a narrative review [J ] . J Clin Med , 2023 , 12 ( 5 ): 1833 .
XU F H , ZHU H , DONG Y J , et al . Combined inflammatory parameters and tertiary lymphoid structure predict prognosis in patients with resectable non-small cell lung cancer treated with neoadjuvant chemoimmunotherapy [J ] . Front Immunol , 2023 , 14 : 1244256 .
WANG Z , LI X X , CHEN J H , et al . The significance of inflammatory markers in prognosticating the effectiveness and safety of immunotherapy in conjunction with chemotherapy during the primary intervention of advanced non-small cell lung carcinoma [J ] . Lung Cancer , 2024 , 192 : 107817 .
ZHANG T T , LI S L , CHANG J H , et al . Impact of BMI on the survival outcomes of non-small cell lung cancer patients treated with immune checkpoint inhibitors:a meta-analysis [J ] . BMC Cancer , 2023 , 23 ( 1 ): 1023 .
GUO Y Z , WEI L , PATEL S H , et al . Serum albumin:early prognostic marker of benefit for immune checkpoint inhibitor monotherapy but not chemoimmunotherapy [J ] . Clin Lung Cancer , 2022 , 23 ( 4 ): 345 - 355 .
石明伟 , 王俊康 , 王静 . 系统免疫炎症营养指数对接受免疫检查点抑制剂治疗的非小细胞肺癌患者临床疗效及预后的评估价值研究 [J ] . 解放军医学院学报 , 2023 , 44 ( 12 ): 1372 - 1378,1383 .
谢剑华 , 刘苗苗 , 彭丽丽 , 等 . 系统免疫炎症营养指数与非手术治疗老年非小细胞肺癌患者预后的关系研究 [J ] . 中国全科医学 , 2022 , 25 ( 17 ): 2082 - 2089 .
YUAN L , WANG Q , SUN F , et al . Deep learning and inflammatory markers predict early response to immunotherapy in unresectable NSCLC:a multicenter study [J ] . Biomol Biomed , 2025 , 25 ( 10 ): 2252 - 2268 .
LURIENNE L , CERVESI J , DUHALDE L , et al . NSCLC immunotherapy efficacy and antibiotic use:a systematic review and meta-analysis [J ] . J Thorac Oncol , 2020 , 15 ( 7 ): 1147 - 1159 .
ALKAN ŞEN G , NIHAN Ş Ö , DEĞERLI E , et al . Effect of antibiotic treatment on immune checkpoint inhibitors efficacy in patients with advanced non-small cell lung cancer [J ] . Lung Cancer , 2023 , 184 : 107347 .
WU Q , LIU J J , WU S M , et al . The impact of antibiotics on efficacy of immune checkpoint inhibitors in malignancies:a study based on 44 cohorts [J ] . Int Immunopharmacol , 2021 , 92 : 107303 .
CHEN H , HAN K D , HE Z J , et al . How to choose a survival period? The impact of antibiotic use on OS or PFS in NSCLC patients treated with immune checkpoint inhibitors:a systematic review and meta-analysis [J ] . Technol Cancer Res Treat , 2021 , 20 : 15330338211033498 .
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