Efficacy and safety of immune checkpoint inhibitors combined with neoadjuvant chemotherapy in the treatment of early triple-negative breast cancer： a meta-analysis

YANG Zhixuan; LI Shuo; WANG Peiyuan; QIE Hongxin; GONG Wenlin; GAO Xiaonan; GAO Jinglin; WANG Mingxia

doi:10.6039/j.issn.1001-0408.2026.02.18

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Efficacy and safety of immune checkpoint inhibitors combined with neoadjuvant chemotherapy in the treatment of early triple-negative breast cancer： a meta-analysis

更新时间：2026-02-10

- Efficacy and safety of immune checkpoint inhibitors combined with neoadjuvant chemotherapy in the treatment of early triple-negative breast cancer： a meta-analysis
- ZHONGGUO YAOFANG Vol. 37, Issue 2, Pages: 238-243(2026)
- 作者机构：
  
  1.河北医科大学第四医院临床药理研究部，石家庄　050011
  2.河北省肿瘤微环境与耐药重点实验室，石家庄　050011
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2026.02.18
  CLC： R979.1
- Received：08 September 2025，
  
  Revised：2026-01-05，
  
  Accepted：05 January 2026，
  
  Published：30 January 2026
- 稿件说明：
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杨芷轩,李硕,王培源,等.ICIs联合新辅助化疗用于早期三阴性乳腺癌疗效与安全性的Meta分析 [J].中国药房,2026,37(02):238-243.

YANG Zhixuan,LI Shuo,WANG Peiyuan,et al.Efficacy and safety of immune checkpoint inhibitors combined with neoadjuvant chemotherapy in the treatment of early triple-negative breast cancer： a meta-analysis[J].ZHONGGUO YAOFANG,2026,37(02):238-243.
杨芷轩,李硕,王培源,等.ICIs联合新辅助化疗用于早期三阴性乳腺癌疗效与安全性的Meta分析 [J].中国药房,2026,37(02):238-243. DOI： 10.6039/j.issn.1001-0408.2026.02.18.

YANG Zhixuan,LI Shuo,WANG Peiyuan,et al.Efficacy and safety of immune checkpoint inhibitors combined with neoadjuvant chemotherapy in the treatment of early triple-negative breast cancer： a meta-analysis[J].ZHONGGUO YAOFANG,2026,37(02):238-243. DOI： 10.6039/j.issn.1001-0408.2026.02.18.

摘要

目的

评价免疫检查点抑制剂联合新辅助化疗用于早期三阴性乳腺癌的疗效和安全性。

方法

检索PubMed、Cochrane Library、Embase、Web of Science、中国知网、万方数据、维普网以及肿瘤学术会发表的相关研究，收集免疫检查点抑制剂联合新辅助化疗（试验组）对比新辅助化疗（对照组）的随机对照试验（RCT），检索时限为建库起至2025年6月30日。筛选文献、资料提取，评价质量后，采用RevMan 5.4软件进行Meta分析。

结果

最终纳入6项RCT，共计3 786例患者。Meta分析结果显示，试验组患者的无事件生存期[HR＝0.73，95%CI（0.62，0.85），

＜0.000 1

]

、总生存期[HR＝0.69，95%CI（0.57，0.84），

＝0.000 3

]

、病理完全缓解率（pCR）[OR＝1.57，95%CI（1.37，1.80），

＜0.000 01

]

均显著高于对照组。试验组患者的≥3级不良事件（AE）发生率、严重不良事件（SAE）发生率、≥3级免疫相关不良事件（irAE）发生率均显著高于对照组；两组患者的任意AE发生率和任意irAE发生率比较，差异均无统计学意义（

＞0.05）。亚组分析结果显示，无论程序性死亡配体-1表达阴性或阳性，试验组患者的pCR均显著高于对照组（

＜0.05）；试验组淋巴结阳性患者的pCR显著高于对照组（

＜0.05），而两组淋巴结阴性患者的pCR比较，差异无统计学意义（

＝0.09）。

结论

免疫检查点抑制剂联合新辅助化疗能显著改善早期三阴性乳腺癌患者的无事件生存期和总生存期，患者可获得长期生存获益，但≥3级AE、SAE、≥3级irAE的发生风险有所增加。

Abstract

OBJECTIVE

To evaluate the efficacy and safety of immune checkpoint inhibitors （ICIs） combined with neoadjuvant chemotherapy in the treatment of early triple-negative breast cancer （TNBC）.

METHODS

Randomized controlled trials （RCTs） comparing ICIs combined with neoadjuvant chemotherapy （experimental group） versus neoadjuvant chemotherapy alone （control group） were retrieved from PubMed， Cochrane Library， Embase， Web of Science， CNKI， Wanfang Data， and VIP databases， as well as relevant studies published at oncology academic conferences. The search period was from database inception to June 30， 2025. After literature screening， data extraction， and quality assessment， a meta-analysis was performed by using RevMan 5.4 software.

RESULTS

A total of 6 RCTs involving 3 786 patients were finally included. The meta-analysis results showed that the experimental group had superior event-free survival [HR＝0.73， 95%CI （0.62， 0.85），

＜0.000 1

]

， overall survival [HR＝0.69， 95%CI （0.57， 0.84），

＝0.000 3

]

， and pathological complete response （pCR） [OR＝1.57， 95%CI （1.37， 1.80），

＜0.000 01

]

compared to the control group. The incidence of ≥grade 3 adverse event （AE）， severe AE （SAE）， and ≥grade 3 immune-related adverse event （irAE） in the experimental group was significantly higher than that in the control group. There was no statistically significant difference between the two groups in the incidence of any AE or any irAE （

＞0.05）. Subgroup analysis revealed that， regardless of programmed cell death ligand 1 expression status （negative or positive）， the pCR in the experimental group was significantly higher than that in the control group （

＜0.05）. Additionally， the pCR of the patients with positive lymph nodes in the experimental group was significantly higher to that in the control group （

＜0.05）. There was no statistically significant difference in pCR between the two groups with negative lymph nodes （

＝0.09）.

CONCLUSIONS

ICIs combined with neoadjuvant chemotherapy can significantly improve event-free survival and overall survival in patients with TNBC， providing patients with long-term survival benefits. However， the risk of ≥ grade 3 AE， SAE and ≥ grade 3 irAE has increased.

关键词

Keywords

references

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