Peripheral Blood Cells As Prognostic Markers in Patients with Advanced Non-Small Cell Lung Cancer Treated with Cemiplimab As Monotherapy or in Combination with Chemotherapy.

BACKGROUND:Patients with a high neutrophil/lymphocyte ratio (NLR) have poor prognosis in non-small cell lung cancer (NSCLC). Limited data are available on the contribution of other immune cells. This analysis assessed the prognostic importance of NLR and other peripheral blood cells in patients with advanced NSCLC receiving the PD-1 inhibitor cemiplimab in 2 large phase III studies. METHODS:The impact of baseline immune cells on survival was assessed in patients with complete blood cell counts. Cox proportional hazard regression and Kaplan-Meier methods assessed the relationships between baseline blood cell counts and survival. Data were randomly split into training (70 %) and validation (30 %) cohorts to allow for independent evaluation of the Cox model. RESULTS:Multivariable analyses revealed that a higher NLR (HR: 1.09; 95 % CI: 1.06-1.12, P < .001) and monocytes (HR: 1.49; 95 % CI: 1.15-1.93, P < .001) were strongly associated with an increased risk of death. Higher levels of eosinophils (HR: 0.93; 95 % CI: 0.88-0.99, P < .001) were associated with a reduced risk of death. A calibration curve of observed and predicted probabilities in the unseen test set using independent data revealed that the Cox model was well-calibrated up to a 1-year mortality probability of approximately 30 %. Harrell's concordance index was 0.61, indicating a modest predictive performance. CONCLUSIONS:Our data confirmed the detrimental impact of a high NLR on survival and revealed the importance of monocyte levels in anti-tumor responses, providing useful information to physicians treating advanced NSCLC that may help tailor immunotherapy regimens and provide more accurate prognostic assessments.