Details

Autor(en) / Beteiligte

• Fornarini, G.
• Rebuzzi, S.E.
• Banna, G.L.
• Calabrò, F.
• Scandurra, G.
• De Giorgi, U.
• Masini, C.
• Baldessari, C.
• Naglieri, E.
• Caserta, C.
• Manacorda, S.
• Maruzzo, M.
• Milella, M.
• Buttigliero, C.
• Tambaro, R.
• Ermacora, P.
• Morelli, F.
• Nolè, F.
• Astolfi, C.
• Sternberg, C.N.

Titel

Immune-inflammatory biomarkers as prognostic factors for immunotherapy in pretreated advanced urinary tract cancer patients: an analysis of the Italian SAUL cohort

Ist Teil von

• ESMO open, 2021-06, Vol.6 (3), p.100118-100118, Article 100118

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2021

Link zum Volltext

Quelle

EZB Free E-Journals

Beschreibungen/Notizen

• Reliable and affordable prognostic and predictive biomarkers for urothelial carcinoma treated with immunotherapy may allow patients' outcome stratification and drive therapeutic options. The SAUL trial investigated the safety and efficacy of atezolizumab in a real-world setting on 1004 patients with locally advanced or metastatic urothelial carcinoma who progressed to one to three prior systemic therapies. Using the SAUL Italian cohort of 267 patients, we investigated the prognostic role of neutrophil-to-lymphocyte ratio (NLR) and systemic immune-inflammation index (SII) and the best performing one of these in combination with programmed death-ligand 1 (PD-L1) with or without lactate dehydrogenase (LDH). Previously reported cut-offs (NLR >3 and NLR >5; SII >1375) in addition to study-defined ones derived from receiver operating characteristic (ROC) analysis were used. The cut-off values for NLR and SII by the ROC analysis were 3.65 (sensitivity 60.4; specificity 63.0) and 884 (sensitivity 64.4; specificity 67.5), respectively. The median overall survival (OS) was 14.7 months for NLR <3.65 [95% confidence interval (CI) 9.9-not reached (NR)] versus 6.0 months for NLR ≥3.65 (95% CI 3.9-9.4); 14.7 months for SII <884 (95% CI 10.6-NR) versus 6.0 months for SII ≥884 (95% CI 3.7-8.6). The combination of SII, PD-L1, and LDH stratified OS better than SII plus PD-L1 through better identification of patients with intermediate prognosis (77% versus 48%, respectively). Multivariate analyses confirmed significant correlations with OS and progression-free survival for both the SII + PD-L1 + LDH and SII + PD-L1 combinations. The combination of immune-inflammatory biomarkers based on SII, PD-L1, with or without LDH is a potentially useful and easy-to-assess prognostic tool deserving validation to identify patients who may benefit from immunotherapy alone or alternative therapies. •Reliable biomarkers for immunotherapy may assist in treatment decision making and clinical trial design and interpretation.•Immune-inflammatory biomarkers were investigated for their prognostic role within the Italian SAUL study cohort.•ROC-based cut-offs were 3.65 for NLR and 884 for SII.•Both NLR and SII were prognostic with SII performing slightly better than NLR.•The combination of SII, PD-L1, and LDH stratified OS better than SII + PD-L1; both were independent prognostic factors.