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Banna, G.L.; Cortellini, A.; Cortinovis, D.L.; Tiseo, M.; Aerts, J.G.J.V.; Barbieri, F.; Giusti, R.; Bria, E.; Grossi, F.; Pizzutilo, P.; Berardi, R.; Morabito, A.; Genova, C.; Mazzoni, F.; Di Noia, V.; Signorelli, D.; Gelibter, A.; Macerelli, M.; Rastelli, F.; Chiari, R.; Rocco, D.; Gori, S.; De Tursi, M.; Di Marino, P.; Mansueto, G.; Zoratto, F.; Filetti, M.; Montrone, M.; Citarella, F.; Marco, R.; Cantini, L.; Nigro, O.; D'Argento, E.; Buti, S.; Minuti, G.; Landi, L.; Guaitoli, G.; Lo Russo, G.; De Toma, A.; Donisi, C.; Friedlaender, A.; De Giglio, A.; Metro, G.; Porzio, G.; Ficorella, C.; Addeo, A.
ESMO open, 04/2021, Volume: 6, Issue: 2Journal Article
To stratify the prognosis of patients with programmed cell death-ligand 1 (PD-L1) ≥ 50% advanced non-small-cell lung cancer (aNSCLC) treated with first-line immunotherapy. Baseline clinical prognostic factors, the neutrophil-to-lymphocyte ratio (NLR), PD-L1 tumour cell expression level, lactate dehydrogenase (LDH) and their combination were investigated by a retrospective analysis of 784 patients divided between statistically powered training (n = 201) and validation (n = 583) cohorts. Cut-offs were explored by receiver operating characteristic (ROC) curves and a risk model built with validated independent factors by multivariate analysis. NLR < 4 was a significant prognostic factor in both cohorts (P < 0.001). It represented 53% of patients in the validation cohort, with 1-year overall survival (OS) of 76.6% versus 44.8% with NLR > 4, in the validation series. The addition of PD-L1 ≥ 80% (21% of patients) or LDH < 252 U/l (25%) to NLR < 4 did not result in better 1-year OS (of 72.6% and 74.1%, respectively, in the validation cohort). Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 P < 0.001, hazard ratio (HR) 2.04, pretreatment steroids (P < 0.001, HR 1.67) and NLR < 4 (P < 0.001, HR 2.29) resulted in independent prognostic factors. A risk model with these three factors, namely, the lung immuno-oncology prognostic score (LIPS)-3, accurately stratified three OS risk-validated categories of patients: favourable (0 risk factors, 40%, 1-year OS of 78.2% in the whole series), intermediate (1 or 2 risk factors, 54%, 1-year OS 53.8%) and poor (>2 risk factors, 5%, 1-year OS 10.7%) prognosis. We advocate the use of LIPS-3 as an easy-to-assess and inexpensive adjuvant prognostic tool for patients with PD-L1 ≥ 50% aNSCLC. •Immunotherapy/chemoimmunotherapy combinations are currently not superior to immunotherapy alone for high PD-L1 aNSCLC.•NLR with a cut-off of 4 was validated as an independent prognostic factor for immunotherapy in high PD-L1 aNSCLC.•The addition of either PD-L1 ≥ 80% or LDH < 252 U/l to NLR < 4 did not result in better prognostic stratification.•The LIPS-3 is a validated 3-class prognostic classification based on the NLR, ECOG PS and pretreatment steroids.•The LIPS-3 is a routinely assessable adjuvant prognostic tool for high PD-L1 aNSCLC patients.
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