Triple‑negative breast cancer (TNBC) is a subtype of breast cancer that is negative for oestrogen receptor, progesterone receptor and human epidermal growth factor receptor 2 expression. Locally advanced and metastatic TNBC not only have a worse prognosis and are more invasive than TNBC, but are also the most immunogenic subtypes of breast cancer. There is still a lack of clarity regarding the optimal treatment of locally advanced or metastatic TNBC. The present study aimed to assess the efficacy and safety of programmed cell death protein 1 (PD‑1)/programmed death ligand 1 (PD‑L1) inhibitor‑based immunotherapy [i.e., immune checkpoint inhibitors (ICIs)] alone or in combination with other therapies for the treatment of locally advanced or metastatic TNBC. The PubMed, Cochrane Library, Embase and MEDLINE databases were searched up to July 19, 2023 to identify studies that examined the efficacy and safety of ICIs for treating TNBC. The primary outcomes were progression‑free survival (PFS) and overall survival (OS). The secondary outcomes were safety and adverse events. The data were analysed using Review Manager 5.4. A total of 8 studies (3,338 patients) were included in the present meta‑analysis. Compared with other therapies, ICIs had a significantly different effect on OS [hazard ratio (HR)=0.83; 95% confidence interval (CI)=0.69‑1.00; P<0.05; I²=59%] in patients with locally advanced or metastatic TNBC. In addition, ICIs significantly prolonged PFS compared with other therapies (intent‑to‑treat: HR=0.81; 95% CI=0.75‑0.88; P<0.00001; I²=0%). Immunotherapy based on PD‑1/PD‑L1 inhibitors showed variable efficacy on OS and PFS in TNBC, while a significant improvement was observed for PD‑L1(+). Future studies should focus on PD‑L1 subgroup status, which may help optimize personalized treatment regimens for TNBC.

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