First-line pembrolizumab efficacy in patients with advanced non-small cell lung cancer: A Bi-center retrospective, real-life experience study.

Purpose Immune checkpoint inhibitors (ICIs) have caused a paradigm shift in the treatment landscape of advanced non-small cell lung cancer (NSCLC). Real-world practice may be different from randomized studies. The purpose of this study was to investigate the real-world pembrolizumab efficacy with or without chemotherapy. Methods All consecutive patients aged over 18 years who were diagnosed as metastatic NSCLC and received at least one dose of first-line pembrolizumab treatment were retrospectively reviewed. The patients hadn't received no previous systemic therapy. Results A total of 44 patients treated with pembrolizumab were enrolled. Just over half (51.2%) of the patients had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) 2, and 36.4% had liver metastasis. There were no patients with driver mutations, 18.2% had programmed death ligand-1 (PD-L1) 50% expression and 82.3% were treated with pembrolizumab plus chemotherapy. The median progression-free survival (PFS) and overall survival (OS) were 3.0 months (95% CI: 0.9-5.0 months) and 6.6 months (95% CI: 0.7-12.4 months), respectively. Multivariate analysis identified liver metastasis and adrenal metastasis as independent predictors of OS. Conclusions PFS, OS, objective response and disease control rate results were significantly worse than in randomized studies. ICIs are not an infallible treatment option to be used for every patient with advanced NSCLC encountered in daily clinical practice. Attention should be payed to stringent eligibility criteria used in randomized studies as much as possible and try to manage patients according to these criteria.