Abstract 954P
Background
Recurrent or Metastatic Platinum-refractory Squamous Cell Carcinoma of the Head and Neck (R-M SCCHN) is a major clinical issue with 1 year survival rate of 20-30% and a median OS of 10 months. Nivolumab, anti-PD1 mAb, is approved for 2nd line R-M HNC, but only 15-20% of patients will benefit.
Methods
Aim of the study was to analyze the changes of a panel of 17 circulating cytokines and interleukins during nivolumab treatment at baseline (T0), at day 1 cycle 3 (T1), at day 1 cycle 7 (T2) and at disease progression (PD), (T3). Cytokines’ concentrations were assessed in plasma samples using the Simple Plexsystem (ProteinSimple, San Jose, CA, USA). Basal values and longitudinal changes were correlated with outcome. P<0.05 was considered for statistical significance.
Results
16 patients were analyzed. Longitudinal analysis showed that CXCL-10, TNF-α and IFN-γ increased from T0 to T3 (P=0.0233; P=0.049 and P=0.035, respectively). IL-15 increased from T0 to T2 (P=0.024), but decreased at PD (P=0.024). No other significant longitudinal changes were observed. Considering the basal values, we used ROC analysis to cluster all patients in two groups, observing a better PFS in those whose T0 values of IL-5, IL-6 and IL-10 were below than the respective cut-off points (HR 0.12, P=0.01; HR 0.056, P=0.008; HR 0.055, P=0.009) but only IL-5 below the cut-off positively correlated with OS (HR 0.05, P=0.007). We could not perform multivariate analysis due to the limited number of events. Therefore we use PCA analysis to group patients with good or poor PFS using T0 levels of IL-5, IL-6, IL-10, CCL-22 (KMO 0.574, P=0.025); the same analysis allowed to clusterize patients with OS above or below median value using T0 levels of IL-5, IL-6, IL-10, IL-15 (KMO 0.636, P<0.001).
Conclusions
Our results show that nivolumab therapy could increase the levels of IL-15. CXCL-10, TNF-α and IFN-γ increased at PD. Moreover, our data suggest that IL-5, IL-6 and IL-10 might predict the benefit from the treatment.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
G.O.N.O.
Funding
G.O.N.O.
Disclosure
All authors have declared no conflicts of interest.