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Poster display session

2389 - 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)


10 Sep 2017


Poster display session


Ugo De Giorgi


Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371


U. De Giorgi1, G. Procopio2, A. Guida3, A. Bearz4, S. Buti5, U. Basso6, M. Mitterer7, C. Ortega8, P. Bidoli9, F. Ferrau10, L. Crinò11, A. Frassoldati12, P. Marchetti13, E. Mini14, A. Scoppola15, C. Verusio16, G. Fornarini17, G. Cartenì18, C. Caserta19, C.N. Sternberg20

Author affiliations

  • 1 Medical Oncology, Istituto Tumori della Romagna I.R.S.T., 47014 - Meldola/IT
  • 2 Medical Oncology, Fondazione IRCCS - Istituto Nazionale dei Tumori, 20133 - Milan/IT
  • 3 Medical Oncology, Azienda Ospedaliero - Universitaria Policlinico di Modena, 41100 - Modena/IT
  • 4 Medical Oncology, Cro, 33081 - Pordenone/IT
  • 5 Medical Oncology, Azienda Ospedaliera di Parma, 43126 - Parma/IT
  • 6 Medical Oncology, Istituto Oncologico Veneto IRCCS, 35128 - Padova/IT
  • 7 Medical Oncology, Ospedale Franz Tappeiner, Merano/IT
  • 8 Medical Oncology, IRCCS Istituto di Candiolo, 10060 - Candiolo/IT
  • 9 Medical Oncology Unit, San Gerardo Hospital, Monza (MI)/IT
  • 10 Medical Oncology, Ospedale San Vincenzo, 98039 - Taormina/IT
  • 11 Medical Oncology, Ospedale S. Maria della Misericordia, 06156 - Perugia/IT
  • 12 Medical Oncology, Azienda Ospedaliera di Ferrara St. Anna, 44100 - Ferrara/IT
  • 13 Medical Oncology, Azienda Ospedaliera St. Andrea, 00189 - Roma/IT
  • 14 Department Of Experimental And Clinical Medicine, University of Florence, Florence/IT
  • 15 Medical Oncology, Istituto Dermopatico dell’Immacolata, Roma, Roma/IT
  • 16 Medical Oncology, Ospedale di Saronno, 21047 - Saronno/IT
  • 17 Medical Oncology, Ospedale “S. Martino”, Genova/IT
  • 18 Medical Oncology, Azienda Ospedaliera di Rilievo Nazionale "Antonio Cardarelli"-AORN A. Cardarelli, 80131 - Napoli/IT
  • 19 Medical Oncology, Azienda Ospedaliera Sta Maria, 5100 - Terni/IT
  • 20 Department Of Oncology, San Camillo and Forlanini Hospitals, 156 - Roma/IT


Abstract 2389


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.


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.


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 


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.

Clinical trial identification

expanded access program

Legal entity responsible for the study

Italian RCC EAP Group




U. De Giorgi: advisory board Bristol-Myers Squib. All other authors have declared no conflicts of interest.

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