Characteristics and influential factors for irAEs in patients with liver cancer caused by tislelizumab

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Characteristics and influential factors for irAEs in patients with liver cancer caused by tislelizumab

更新时间：2025-12-26

- Characteristics and influential factors for irAEs in patients with liver cancer caused by tislelizumab
- ZHONGGUO YAOFANG Vol. 36, Issue 24, Pages: 3107-3112(2025)
- 作者机构：
  
  1.广西医科大学附属肿瘤医院药学部，南宁　530021
  2.广西壮族自治区药品不良反应监测中心，南宁　530021
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2025.24.16
  CLC： R969.3;R979.1
- Received：22 June 2025，
  
  Revised：2025-11-18，
  
  Accepted：18 November 2025，
  
  Published：30 December 2025
- 稿件说明：
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李海萍,沈梦如,韦韬,等.替雷利珠单抗致肝癌患者发生irAEs的特征及影响因素 ^Δ[J].中国药房,2025,36(24):3107-3112.

LI Haiping,SHEN Mengru,WEI Tao,et al.Characteristics and influential factors for irAEs in patients with liver cancer caused by tislelizumab[J].ZHONGGUO YAOFANG,2025,36(24):3107-3112.
李海萍,沈梦如,韦韬,等.替雷利珠单抗致肝癌患者发生irAEs的特征及影响因素 ^Δ[J].中国药房,2025,36(24):3107-3112. DOI： 10.6039/j.issn.1001-0408.2025.24.16.

LI Haiping,SHEN Mengru,WEI Tao,et al.Characteristics and influential factors for irAEs in patients with liver cancer caused by tislelizumab[J].ZHONGGUO YAOFANG,2025,36(24):3107-3112. DOI： 10.6039/j.issn.1001-0408.2025.24.16.

摘要

目的

2

探索替雷利珠单抗致肝癌患者发生免疫相关不良反应（irAEs）的特征及影响因素。

方法

2

回顾性纳入2022年5月至2024年3月于广西医科大学附属肿瘤医院接受替雷利珠单抗治疗的203例肝癌患者，将其分为irAEs组（58例）和非irAEs组（145例），收集并比较2组患者的临床资料。采用多因素Logistic回归模型分析影响irAEs发生的因素并建立预测模型，绘制受试者操作特征（ROC）曲线以评估预测模型对irAEs发生的预测价值；利用Kaplan-Meier法分析irAEs与患者总生存期（OS）以及无进展生存期（PFS）的相关性。

结果

2

肝癌患者使用替雷利珠单抗所致irAEs以1～2级为主（89.71%），主要表现为血液学毒性（42.65%）与肝毒性（20.59%），多见于使用替雷利珠单抗治疗后1～12个周期；与没有基础肝病的肝癌患者相比，有慢性乙型肝炎的肝癌患者的irAEs发生率更高。irAEs组和非irAEs组的中国肝癌分期方案（CNLC）≥Ⅱ期的患者数、白细胞计数、中性粒细胞计数、全身免疫炎症指数（SII）、中性粒细胞与淋巴细胞比值（NLR）的差异均有统计学意义（

P

＜0.05）。多因素Logistic回归分析结果表明，CNLC≥Ⅱ期为影响irAEs发生的独立危险因素（

P

＝0.027）。ROC曲线提示中性粒细胞计数、白细胞计数、NLR和SII对irAEs的发生均显示出一定的预测潜力（曲线下面积分别为0.614、0.592、0.591、0.589）。Kaplan-Meier生存曲线显示irAEs组与非irAEs组患者、irAEs组不同irAEs分级以及不同CNLC分期患者的PFS和OS差异均无统计学意义（

P

＞0.05）。

结论

2

肝癌患者使用替雷利珠单抗所致irAEs的程度较轻（1～2级），主要表现为血液学毒性与肝毒性。合并慢性乙型肝炎的肝癌患者发生irAEs的风险较高。CNLC≥Ⅱ期为影响该药所致irAEs的独立危险因素；中性粒细胞计数、白细胞计数、NLR及SII对irAEs的发生具有一定的预测价值。

Abstract

OBJECTIVE

2

To explore the characteristics and influencing factors of immune-related adverse events （irAEs） induced by tislelizumab in patients with liver cancer.

METHODS

2

A retrospective cohort of 203 liver cancer patients treated with tislelizumab in Guangxi Medical University Cancer Hospital from May 2022 to March 2024 was included. These patients were divided into an irAEs group （58 cases） and a non-irAEs group （145 cases）. Clinical data were collected and compared between the two groups. A multivariate logistic regression model was employed to analyze factors influencing the occurrence of irAEs and establish a predictive model. The receiver operator characteristic （ROC） curve was plotted to evaluate the predictive value of the model for the occurrence of irAEs. The correlation between irAEs and overall survival （OS） as well as progression free survival （PFS） in patients was analyzed using the Kaplan-Meier method.

RESULTS

2

The irAEs induced by tislelizumab in liver cancer patients were predominantly grade 1-2 （89.71%）， mainly manifesting as hematological toxicity （42.65%） and hepatotoxicity （20.59%）， and mostly occurred within 1-12 cycles after tislelizumab treatment. Compared with liver cancer patients without underlying liver diseases， those with chronic hepatitis B had a higher incidence of irAEs. Statistically significant differences were observed between the irAEs and non-irAEs groups in terms of the number of patients with a China Liver Cancer Staging （CNLC） stage ≥Ⅱ， white blood cell count， neutrophil count， systemic immune-inflammation index （SII）， and neutrophil-to-lymphocyte ratio （NLR）（

P

＜0.05）. Multivariate Logistic regression analysis revealed that CNLC stage ≥Ⅱ was an independent risk factor for the occurrence of irAEs （

P

＝0.027）. The ROC curve indicated that neutrophil count， white blood cell count， NLR， and SII all demonstrated certain predictive potential for the occurrence of irAEs （with area under the curve values of 0.614， 0.592， 0.591， and 0.589， respectively）. The Kaplan-Meier survival curve showed no statistically significant differences in PFS and OS between the irAEs and non-irAEs groups， among patients with different grades of irAEs， and among irAEs patients with different CNLC stages （

P

＞0.05）.

CONCLUSION

2

The irAEs induced by tislelizumab in liver cancer patients are relatively mild （grade 1-2），mainly manifesting as hematological toxicity and hepatotoxicity. Liver cancer patients with concurrent chronic hepatitis B are at a higher risk of developing irAEs. CNLC stage ≥Ⅱ is an independent risk factor for irAEs induced by tislelizumab. Neutrophil count， white blood cell count， NLR， and SII have certain predictive value for the occurrence of irAEs.

关键词

Keywords

references

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