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PD-1/PD-L1 Inhibitors Plus Chemotherapy Shows Improved Outcomes in Asian TNBC Patients

• Meta-analysis of five phase 3 trials reveals combination of PD-1/PD-L1 inhibitors with chemotherapy significantly improves progression-free survival in Asian patients with advanced triple-negative breast cancer.

• PD-L1-positive patients showed particularly strong benefits, with significant improvements in both overall survival (HR: 0.62) and progression-free survival (HR: 0.66) compared to chemotherapy alone.

• While the combination therapy demonstrated enhanced efficacy, it was associated with increased immune-related adverse events, most commonly hypothyroidism (14.40%) and dermatitis (10.00%).

A comprehensive meta-analysis of five phase 3 randomized controlled trials has demonstrated significant benefits of combining PD-1/PD-L1 inhibitors with chemotherapy for Asian patients with advanced triple-negative breast cancer (TNBC), particularly in PD-L1-positive cases.
The study, encompassing 1,041 patients, revealed that the combination therapy significantly improved progression-free survival (PFS) with a hazard ratio of 0.74 (95% CI: 0.62, 0.88; P = 0.0008) compared to chemotherapy alone. While overall survival (OS) showed a favorable trend toward the combination therapy, it did not reach statistical significance in the general population (HR: 0.78 [0.55, 1.12], P = 0.18).

Enhanced Efficacy in PD-L1-Positive Patients

The most striking benefits were observed in PD-L1-positive patients, where the combination therapy demonstrated significant improvements in both OS (HR: 0.62 [0.44, 0.86], P = 0.005) and PFS (HR: 0.66 [0.50, 0.86], P = 0.003). These patients exhibited notably higher survival rates at the 12-36 month mark and improved progression-free survival between 6-30 months.

Safety Profile and Adverse Events

While the combination therapy showed promising efficacy, it was associated with an increased incidence of immune-related adverse events (irAEs). The risk ratio for irAEs was 1.69 (95% CI: 1.33, 2.15, P < 0.0001), with grade 3-5 events occurring at a risk ratio of 3.11 (95% CI: 1.59, 6.10, P = 0.001). The most frequently reported irAEs included:
  • Hypothyroidism (14.40%)
  • Dermatitis (10.00%)
  • Infusion reactions (8.85%)
Notably, both treatment arms showed comparable response rates and treatment-related adverse events (TRAEs).

Clinical Implications

These findings are particularly significant given the unique biological and genetic characteristics of TNBC in Asian populations. The study provides robust evidence supporting the use of PD-1/PD-L1 inhibitors in combination with chemotherapy as a viable treatment strategy for advanced TNBC in Asian patients, despite the increased risk of immune-related adverse events.
The results suggest that careful patient selection, particularly focusing on PD-L1 status, may help identify those most likely to benefit from this combination approach. Regular monitoring for immune-related adverse events remains crucial for optimal patient management.
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