Real-world efficacy and safety of neoadjuvant immunochemotherapy in patients with triple-negative breast cancer

Aim To evaluate the real‑world efficacy and safety of adding programmed cell death protein 1 (PD-1) inhibitors to neoadjuvant chemotherapy in Chinese patients with triple‑negative breast cancer (TNBC).Patients and methods This single-center retrospective study enrolled 218 TNBC patients receiving neoadjuvant therapy, including 116 in the neoadjuvant chemotherapy (NAC) cohort and 102 in the neoadjuvant immunochemotherapy (NAIC) cohort. Clinical, biological, pathological and therapeutic data were collected. Primary endpoints were pathological complete response (pCR) and event-free survival (EFS).Results Multivariate analysis showed Ki-67 >30% (p = 0.003) and PD-1 inhibitor addition (p < 0.001) were independently associated with higher pCR. NAIC significantly reduced recurrence (7.8% vs. 25.0%, p < 0.001). Miller-Payne grades 2–4 were independent prognostic factors for improved EFS compared with grade 1 (all p < 0.05); grade 5 was excluded due to collinearity with pCR. Except for immune-related adverse events (irAEs), the incidence of other adverse events (AEs) showed no significant differences between the two groups (all p > 0.05).Conclusions Compared with NAC alone, NAIC significantly improves the pCR rate and reduces the recurrence risk in TNBC patients, with generally manageable toxicity in this real-world cohort, which supports its favorable clinical application value.