Efficacy and Safety of Immunochemotherapy in Advanced Triple-negative Breast Cancer: A Meta-analysis of Randomised Clinical Trials

Abstract

Aims

Based on the existing controversial clinical research results, this study conducted a comprehensive meta-analysis of relevant literature to clarify the benefits of immunochemotherapy (ICT)—which combines immune checkpoint inhibitors and chemotherapy (CT)—for patients with advanced triple-negative breast cancer (aTNBC).

Materilas and methods

A thorough literature search was conducted up to February 15, 2024. Subsequently, meta-analyses were performed to aggregate hazard ratios (HRs) for progression-free survival (PFS) and overall survival (OS), odds ratios (ORs) for objective response rate (ORR) and relative risks (RRs) for adverse events (AEs).

Results

Six randomised clinical trials (RCTs) involving 3,105 patients met the inclusion criteria. In comparison with CT, ICT yielded significant enhancements in PFS (HR, 0.80; 95%CI: 0.73–0.87), OS (HR, 0.87; 95%CI: 0.80–0.96), and ORR (OR, 1.34; 95%CI: 1.15–1.55) in the intention-to-treat population. However, ICT also exhibited an increase in grade ≥3 AEs (RR, 1.11; 95%CI: 1.04–1.19) and severe AEs (RR, 1.40; 95%CI: 1.18–1.66). Subgroup analyses revealed that ICT significantly improved PFS (HR, 0.67; 95%CI: 0.58–0.77), OS (HR, 0.75; 95%CI: 0.64–0.87), and ORR (OR, 1.47; 95%CI: 1.16–1.84) within the PD-L1-positive subgroup, whereas no statistically significant differences were detected for PD-L1-negative population.

Conclusion

ICT demonstrates superior efficacy over conventional CT in the treatment of aTNBC, albeit accompanied by heightened toxicity. Notably, the assessment of PD-L1 status may serve as a valuable biomarker in discerning aTNBC patients who are particularly predisposed to derive benefit from ICT.

PROSPERO number

CRD42024513270.