Real‑world evaluation of the efficacy of immune checkpoint inhibitors in the treatment of metastatic breast cancer.

The present study aimed to assess the efficacy and safety of immune checkpoint inhibitor (ICI)-based therapy in patients with metastatic breast cancer (MBC). Therefore, eligible patients with histologically confirmed MBC, treated with ICI-based therapy, were enrolled. The primary endpoint was progression-free survival (PFS) and the secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS) and safety. A total of 90 patients with MBC, treated with ICI-based therapy, with different treatment lines, were included in the present study. The median age was 50 years (range, 27-76). The predominant tumor subtypes were triple negative (53.3%) and luminal (31.1%) breast cancer. The majority of patients (61.1%) were heavily pretreated (lines of treatment, ≥3). Approximately half of the patients (46.7%) had ≥3 metastatic sites. The overall ORR was 36.7% (33/90 patients), while a DCR of 78.9% (71/90 patients) was also recorded. With a median follow-up of 16.0 months, the median PFS and OS were 4.9 months [95% confidence interval (CI), 3.8-6.1] and 13.9 months (95% CI, 9.5-18.2), respectively. Patients treated with ICIs as first-line therapy exhibited notable improvement, with a median PFS of 11.0 months (95% CI, 6.0-16.0) and a median OS of 24.3 months (95% CI, 11.4-37.2). In addition, the pretreatment blood platelet-to-lymphocyte ratio was an independent risk factor for PFS [hazard ratio (HR)=2.406; 95% CI, 1.325-4.370; P=0.004] and OS (HR=2.376; 95% CI, 1.059-5.328; P=0.036). The most common adverse events were nausea (44.4%), neutropenia (42.0%) and alanine aminotransferase/aspartate aminotransferase elevation (22.2%). Furthermore, three (3.3%) patients developed grade 1/2 immuno-related toxicity and recovered after supportive care. Overall, the present study suggested that the ICI-based therapy exhibited encouraging clinical outcomes with manageable toxicity in patients with MBC in real-world settings, with the most favorable efficacy in first-line treatment.