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G. Missale

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    Epidemiology and innovations in biomarker development (ID 42)

    • Event: ELCC 2017
    • Type: Poster Discussion session
    • Track:
    • Presentations: 1
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      30PD_PR - Circulating immune-profile as predictor of outcome in NSCLC patients treated with nivolumab (ID 510)

      16:45 - 17:45  |  Author(s): G. Missale

      • Abstract

      PD-1/PD-L1 axis blockade is of pivotal interest in NSCLC, where the relative antibodies have shown relevant activity. Detection of markers able to predict the activity of these treatments is an importance issue. The predictive role of PD-L1 evaluated by IHC is debated in NSCLC, also, considering that small biopsies or cytological specimens represent often the only tumor material available. This study aimed to assess a circulating immuno-profile as predictor of outcome in NSCLC patients treated with nivolumab.

      A peripheral blood immuno-profile evaluation was performed at three different times: At baseline (T0), after 2 cycles (T1) and after 4 cycles (T2) of Nivolumab in 54 advanced pre-treated NSCLC patients treated in an Expanded Access Program in two Italian institutions. Tumor assessment was performed after 4 cycles and every 2 months. FACS analysis of lymphocyte subpopulations [CD3, CD4, CD8, NK (CD56) and Treg (FOXP3)] was performed. In addition to changes in absolute number and % of these populations, they were also characterized for their functional and proliferative activity. Quali-quantitative leucocyte composition at baseline and its change during therapy were correlated with tumor response and overall survival.

      Baseline Neutrophil-to-Lymphocyte Ratio, baseline NK count, lymphocyte count and CD4 variations during therapy showed a statistically significant prognostic role (p < 0.001; p = 0.012; p < 0.001; p = 0.010, respectively). Preliminary results on 31 patients with all 3 time-points samples, showed: A significant increase of NK cells and a significant decrease of CD4% from T0 to T2; a significant increase from T0 to T2 of NK subpopulation CD56dim (with reduction of CD56bright); considering two groups of patients (19 responders vs. 12 non-responders), a NK increase (overall and of CD56dim) and CD4% decrease was observed in responders and non-responders, respectively; absolute number and % of NK at baseline was statistically different in the two groups; absolute number and % of CD8+/PD1+ at baseline was significantly higher in responders vs. non-responders.

      These data show that it is possible to identify predictive peripheral immuno-biomarkers, such as NK and CD8, for nivolumab therapy in advanced NSCLC.

      Clinical trial identification:

      Legal entity responsible for the study:
      University Hospital of Parma


      All authors have declared no conflicts of interest.