EPSILoN: a prognostic score using clinical and blood biomarkers in advanced non-small cell lung cancer patients treated with immunotherapy

Abstract Background Second-line immunotherapy (IO) showed overall survival (OS) benefit, but only 18-20% of aNSCLC patients respond with a median progression-free survival (mPFS) of 2-4 months. Biomarkers to select patients most likely to benefit from IO are greatly needed. Patients and Methods We conducted a retrospective analysis of 154 aNSCLC patients receiving anti-PD1 therapy as > 2nd line. We assessed at baseline (T0), second (T1) and third (T2) cycle absolute neutrophil (ANC), lymphocyte (ALC), monocyte (AMC) and eosinophil count (AEC). Neutrophil-lymphocyte ratio (NLR), derived-NLR (dNLR), lymphocyte-monocyte ratio (LMR) and their percentage change at T1 and T2 compared to T0 (T0-T1; T0-T2) were evaluated. Clinical characteristics and LDH were also considered. Univariate and multivariate analysis were performed. Significant biomarkers from multivariate analyses on PFS were combined in a prognostic score. Results For OS the negative prognostic biomarkers were ECOG-PS 2, NLR T0 and dNLR T1, while LMR T0/T1/T2 was identified as positive prognostic biomarker. For PFS negative prognostic biomarkers were ECOG-PS 2, liver metastases, NLR T0, dNLR T1/T2 and > 30% increase of NLR T0-T1, while positive prognostic biomarkers were heavy smoking, LDH, LMR T2. The > 30% increase of LMR T0-T1/T0-T2 correlated with ORR. A prognostic score (e-score) (smoking, ECOG-PS, liver metastases, LDH, NLR) identified three prognostic groups (mPFS: 10.2, 4.9 and 1.7 months; p Conclusions EPSILoN score as a result of combination of five baseline clinical and blood biomarkers can help to identify aNSCLC patients who will most likely benefit from second-line immunotherapy. Further studies are warranted.