Objective:

To evaluate the efficacy and safety of immune checkpoint inhibitors (ICIs) combined with chemotherapy for advanced triple-negative breast cancer (TNBC).

Approach:

• Search Strategy: Systematic search of PubMed, Web of Science, and Embase for relevant articles up to August 2025, assessing methodological quality and evidence certainty.
• Data Analysis: Included 11 meta-analyses comprising 39,147 patients; examined overall survival (OS), progression-free survival (PFS), and objective response rate (ORR), along with adverse events (AEs).

Key Findings:

• ICIs combined with chemotherapy significantly improved overall survival (OS, HR = 0.89) and progression-free survival (PFS, HR = 0.81) compared to chemotherapy alone.
• No statistically significant improvement in objective response rate for PD-L1-negative (RR = 1.01) or PD-L1-positive (RR = 1.17) populations.
• Combination therapy was associated with increased risks of all-grade and grade ≥3 adverse events, as well as higher incidence of immune-related adverse events.

Interpretation:

ICIs combined with chemotherapy provide survival benefits in advanced TNBC but increase immune-related toxicity.

Limitations:

• Findings concerning hepatitis require cautious interpretation due to limited studies.
• Current evidence limitations necessitate future research with more detailed stratification.

Conclusion:

ICIs combined with chemotherapy confer survival benefits in advanced TNBC, though at the cost of increased immune-related toxicity.

Sources:

• Systematic Review Registration