Abstract
PURPOSE: There is limited clinical evidence comparing different chemotherapy-based combination therapies. This study aimed to evaluate and compare the efficacy and safety of chemotherapy combined with immunotherapy versus chemotherapy combined with anti-angiogenic therapy in the treatment of metastatic triple-negative breast cancer (TNBC). METHODS: This study included patients with metastatic TNBC who received either anti-PD-1 monoclonal antibody or bevacizumab in combination with chemotherapy. The primary endpoint was progression-free survival (PFS); the secondary endpoints included overall response rate (ORR), clinical benefit rate (CBR), and safety. RESULTS: Between October 2018 and June 2024, 130 eligible patients were enrolled. Of these, 60 patients received chemotherapy combined with anti-PD-1 monoclonal antibody, and 70 patients received chemotherapy combined with bevacizumab. The median PFS was 5.9 months (95% CI: 4.3-8.7) in the immunotherapy group, compared to 3.0 months (95% CI: 2.2-4.7) in the bevacizumab group (hazard ratio [HR] = 0.42, 95% confidence interval [CI] 0.28-0.62, p < 0.0001). The ORR rates were 55% in the immunotherapy group and 27.1% in the bevacizumab group (p = 0.001). The CBR rates were 43.3% and 22.9%, respectively (p = 0.013). The overall incidence of adverse events was comparable between the two groups. CONCLUSION: In the treatment of metastatic TNBC, chemotherapy combined with immunotherapy offers significant survival advantages over chemotherapy combined with bevacizumab.