China Pharmacy 2025;36(18):2322-2327

Immune checkpoint inhibitors combined with neoadjuvant chemotherapy and adjuvant chemotherapy in the treatment of early-stage triple-negative breast cancer:a meta-analysis

Chunyan YANG 1 ; Shaohua ZHANG 2 ; Rongkang LI 3 ; Lei PENG 2 ; Li ZHAO 1 ; Jun BIE 1

Affiliations

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Keywords

triple-negative breast cancer; immune checkpoint inhibitors; neoadjuvant chemotherapy; adjuvant chemotherapy

Country

China

Language

Chinese

Abstract

OBJECTIVE To evaluate the efficacy and safety of immune checkpoint inhibitors combined with neoadjuvant chemotherapy and adjuvant chemotherapy in the treatment of early-stage triple-negative breast cancer (TNBC). METHODS A systematic search was conducted in PubMed, Embase, Cochrane Library, CNKI, and Wanfang Data to collect randomized controlled trials (RCT) on the use of immune checkpoint inhibitors combined with neoadjuvant chemotherapy and adjuvant chemotherapy (experimental group) versus neoadjuvant chemotherapy and adjuvant chemotherapy (control group) in the treatment of TNBC. After literature screening, data extraction and literature quality evaluation, meta-analysis was performed using Stata 17.0. RESULTS A total of 5 RCT involving 1 498 patients were included. The meta-analysis results showed that the pathological complete response rate (pCR) [RR=1.34, 95%CI (1.09, 1.63), P=0.03], pCR in patients with positive programmed death-1 (PD-1) and its ligand (PD-L1) [RR=1.33, 95%CI (1.16, 1.51), P=0.01], pCR in patients with positive lymph nodes [RR= 1.56, 95%CI (1.27, 1.93), P=0.01], the incidence of grade 3-4 adverse events (AEs) [RR=1.07, 95%CI (1.01, 1.14), P= 0.04], the incidence of serious AEs [RR=1.57, 95%CI (1.31, 1.87), P=0.03], and the incidence of treatment discontinuation due to AEs [RR=1.45, 95%CI (1.19, 1.76), P=0.01] were significantly higher in the experimental group than control group. There were no statistically significant difference in pCR in patients with negative PD-1/PD-L1[RR= E-mail:biejun23@126.com 1.26, 95%CI (0.98, 1.62), P=0.08] and pCR in patients with negative lymph nodes [RR=1.14, 95%CI (0.97, 1.33), P=0.17] between the two groups. CONCLUSIONS Immune checkpoint inhibitors combined with neoadjuvant chemotherapy and adjuvant chemotherapy demonstrates significant efficacy in early-stage TNBC patients, with more pronounced benefits observed in those who are PD-1/PD-L1 positive and lymph node- positive. However, the incidence of AEs is relatively high.