Table 1_Efficacy and safety of immune checkpoint inhibitors plus chemotherapy in early-stage triple-negative breast cancer: a systematic review and meta-analysis.docx

Between-study heterogeneity was assessed using Cochran’s Q test and the I² statistic. Exploratory subgroup analyses were conducted according to programmed death-ligand 1 (PD-L1) expression and lymph node status.</p>Results<p>Five RCTs were included. Immunotherapy plus chemotherapy was associated with a higher pCR rate than control regimens (RR = 1.44, 95% CI 1.09–1.79), with substantial heterogeneity (I² = 83.7%).

In exploratory analyses, the pooled RR was 1.36 (95% CI 1.18–1.57) in PD-L1-positive patients and 1.18 (95% CI 0.96–1.45) in PD-L1-negative patients. Corresponding RRs were 1.42 (95% CI 1.19–1.69) for node-positive and 1.21 (95% CI 1.02–1.43) for node-negative disease. Immunotherapy-containing regimens were also associated with higher risks of grade 3–4 adverse events (RR = 1.18, 95% CI 1.05–1.33), serious adverse events (RR = 1.42, 95% CI 1.12–1.79), and treatment discontinuation due to adverse events (RR = 1.67, 95% CI 1.18–2.36).</p>Conclusions<p>Immunotherapy combined with chemotherapy was associated with higher pCR rates in early-stage or high-risk TNBC but also with greater treatment-related toxicity.

PD-L1 and nodal subgroup findings should be considered exploratory, and further evidence is needed to clarify long-term clinical outcomes.</p>Systematic review registration<p>[url], identifier [].</p>