Efficacy and safety of immune checkpoint inhibitors combined with neoadjuvant chemotherapy in the treatment of early triple-negative breast cancer：a meta-analysis
- VernacularTitle: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
- Author:
Zhixuan YANG
1
;
Shuo LI
1
;
Peiyuan WANG
1
;
Hongxin QIE
1
;
Wenlin GONG
1
;
Xiaonan GAO
1
;
Jinglin GAO
2
;
Mingxia WANG
1
Author Information
1. Dept. of Clinical Pharmacology，the Fourth Hospital of Hebei Medical University，Shijiazhuang 050011，China
2. Dept. of Clinical Pharmacology，the Fourth Hospital of Hebei Medical University，Shijiazhuang 050011，China;Hebei Provincial Key Laboratory of Tumor Microenvironment and Drug Resistance，Shijiazhuang 050011，China
- Publication Type:Journal Article
- Keywords:
neoadjuvant chemotherapy;
early triple-negative breast cancer;
immune checkpoint inhibitor;
PD-L1 inhibitor;
PD-
- From:
China Pharmacy
2026;37(2):238-243
- CountryChina
- Language:Chinese
-
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）， P＜0.000 1]， overall survival [HR＝0.69， 95%CI （0.57， 0.84）， P＝0.000 3]， and pathological complete response （pCR） [OR＝1.57， 95%CI （1.37， 1.80）， P＜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 （P＞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 （P＜0.05）. Additionally， the pCR of the patients with positive lymph nodes in the experimental group was significantly higher to that in the ontrol group （P＜0.05）. There was no statistically significant difference in pCR between the two groups with negative lymph nodes （P＝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.
