Real-world effectiveness and safety of pembrolizumab monotherapy in non-small-cell lung carcinoma with brain metastases.

OBJECTIVE: The objective of this study was to evaluate the effectiveness and safety of pembrolizumab as monotherapy in patients with Non-Small-Cell Lung Cancer and brain metastases in Real-World clinical practice at Tertiary care. MATERIAL AND METHODS: A retrospective observational study was conducted at a tertiary hospital in Spain between August 2017 and March 2023. Adult patients with stage IV non-small-cell lung carcinoma and radiologically confirmed brain metastases who received pembrolizumab monotherapy were included. Progression-free survival, overall survival, objective response rate and treatment-related adverse events were analyzed. RESULTS: Among 172 patients treated with pembrolizumab, 45 had brain metastases and 25 received monotherapy. Median progression-free survival was 3 months (95% confidence interval: 2.02-3.97), and median overall survival was 6 months (95% confidence interval: 4.37-7.62). The objective response rate was 24%, and the disease control rate was 40%. Treatment-related toxicity of any grade was reported in 64% of patients, with no unexpected safety signals observed. CONCLUSIONS: Pembrolizumab monotherapy showed clinical activity and an acceptable safety profile in patients with non-small-cell lung carcinoma and brain metastases treated in routine practice. Larger prospective studies are needed to optimize patient selection in this setting.