Background: Biomarkers for outcome after immune-checkpoint blockade in mRCC are needed. We aimed to verify the prognostic impact of inflammatory indexes based on baseline values of neutrophils (N), lymphocytes (L) and/or platelets (P) in pts with mRCC included in the Italian nivolumab EAP. Methods: Pts who had received ≥ 1 dose of nivolumab 3 mg/kg every 2 weeks in the Italian EAP after at least one prior systemic therapy for mRCC were enrolled in this study. The pre-treatment systemic immune-inflammation index (SII) defined as P×N/L, neutrophil-to-lymphocyte ratio (NLR) defined as N/L and platelet-to-lymphocyte ratio (PLR) defined as P/L were evaluated to identify a potential correlation with overall survival (OS). X-tile 3.6.1 software was used to identify cut-off values. OS was estimated by the Kaplan-Meier method and compared with the log-rank test. The impact of SII, NLR, and PLR on OS was evaluated by Cox regression analyses and on best overall response rate (ORR) by binary logistic regression. Results: A total of 346 mRCC pts treated with nivolumab were included. SII ≥ 1375, NLR ≥ 3 and PLR ≥ 232 were considered as elevated levels (high risk groups). One-year OS in low and high SII group was 77% and 36%, respectively (p < 0.0001); 1-year OS in low and high NLR was 76% and 58%, respectively (p < 0.0001); 1-year OS in low and high PLR was 76% and 45%, respectively (p < 0.0001). Likewise, best ORR was higher in pts with low SII (p = 0.008), low NLR (p = 0.06) and low PLR (p = 0.004). In multivariate analysis adjusted for age, gender, risk score (MSKCC), ECOG performance status, presence of liver, brain and/or bone mets, SII, NLR and PLR, the model identified SII as the strongest factor associated with OS (p < 0.0001). Conclusions: SII, NLR, and PLR are robust inflammatory prognostic factors for predicting outcome in mRCC pts treated with nivolumab. SII is a more powerful predictive system than the other inflammatory indexes for these pts.
Inflammatory indexes strongly predict clinical outcome in patients (pts) with metastatic renal cell cancer (mRCC) treated with nivolumab: results from the Italian expanded access program (EAP) / De Giorgi, U.; Procopio, G.; Guida, A.; Bearz, A.; Buti, S.; Basso, U.; Mitterer, M.; Ortega, C.; Bidoli, P.; Ferrau, F.; Crinò, L.; Frassoldati, A.; Marchetti, P.; Mini, E.; Scoppola, A.; Verusio, C.; Fornarini, G.; Cartenì, G.; Caserta, C.; Sternberg, C.N.. - In: ANNALS OF ONCOLOGY. - ISSN 0923-7534. - ELETTRONICO. - 28:(2017), pp. 320-321. [10.1093/annonc/mdx371.058]
Inflammatory indexes strongly predict clinical outcome in patients (pts) with metastatic renal cell cancer (mRCC) treated with nivolumab: results from the Italian expanded access program (EAP)
PROCOPIO, GIANMARCO;Marchetti, P.;Mini, E.;
2017
Abstract
Background: Biomarkers for outcome after immune-checkpoint blockade in mRCC are needed. We aimed to verify the prognostic impact of inflammatory indexes based on baseline values of neutrophils (N), lymphocytes (L) and/or platelets (P) in pts with mRCC included in the Italian nivolumab EAP. Methods: Pts who had received ≥ 1 dose of nivolumab 3 mg/kg every 2 weeks in the Italian EAP after at least one prior systemic therapy for mRCC were enrolled in this study. The pre-treatment systemic immune-inflammation index (SII) defined as P×N/L, neutrophil-to-lymphocyte ratio (NLR) defined as N/L and platelet-to-lymphocyte ratio (PLR) defined as P/L were evaluated to identify a potential correlation with overall survival (OS). X-tile 3.6.1 software was used to identify cut-off values. OS was estimated by the Kaplan-Meier method and compared with the log-rank test. The impact of SII, NLR, and PLR on OS was evaluated by Cox regression analyses and on best overall response rate (ORR) by binary logistic regression. Results: A total of 346 mRCC pts treated with nivolumab were included. SII ≥ 1375, NLR ≥ 3 and PLR ≥ 232 were considered as elevated levels (high risk groups). One-year OS in low and high SII group was 77% and 36%, respectively (p < 0.0001); 1-year OS in low and high NLR was 76% and 58%, respectively (p < 0.0001); 1-year OS in low and high PLR was 76% and 45%, respectively (p < 0.0001). Likewise, best ORR was higher in pts with low SII (p = 0.008), low NLR (p = 0.06) and low PLR (p = 0.004). In multivariate analysis adjusted for age, gender, risk score (MSKCC), ECOG performance status, presence of liver, brain and/or bone mets, SII, NLR and PLR, the model identified SII as the strongest factor associated with OS (p < 0.0001). Conclusions: SII, NLR, and PLR are robust inflammatory prognostic factors for predicting outcome in mRCC pts treated with nivolumab. SII is a more powerful predictive system than the other inflammatory indexes for these pts.
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