Progression-Free Survival Under Immune Checkpoint Inhibitors for Metastatic Non-Small-Cell Lung Cancer: A Retrospective Cohort Study.

Introduction: Immune checkpoint inhibitors (ICI) are the standard of care for non-small-cell lung cancer (NSCLC) regardless of program death ligand-1 (PDL1) expression. However, a majority of patients presented early progression, underlining the need for better patient selection. The aim of this study was to determine effective clinical and biological biomarkers of real-world progression-free survival (rwPFS) in addition to PDL1.

Methods: From January 2015 to January 2020, 173 patients with metastatic NSCLC were treated with second line or further nivolumab at the Institut de Cancérologie de l'Ouest (ICO). Using univariate and multivariate analyses, we screened clinical and biological parameters associated with rwPFS. From the independent prognostic variables, a prediction model of 9 and 12 months of median PFS was calculated using a nomogram. This model was validated in a second retrospective cohort of 253 patients with NSCLC from eight centers.

Results: In the first cohort, we found five independent prognostic biomarkers: bone and lung metastases, current smoking status, PFS in first line (PFS1), and neutrophil-to-lymphocyte ratio (NLR). The nomogram identified three distinct prognostic groups with respective median rwPFS values of 11.7, 3.9, and 1.6 months. This prediction model was confirmed in our second retrospective cohort.

Conclusions: We created a predictive model on the basis of five simple biomarkers that may predict the efficacy of ICI regardless of PDL1 status. The presence of lung metastases, prolonged PFS1, low NLR, and smoking status are good prognostic factors, whereas the presence of bone metastases was associated with worse prognosis.