Available pre-treatment metastatic tumor samples were assessed for TILs density, according to the suggested international guidelines [19 (link)]. Cut-offs explored for TILs evaluation were ≥ 5%, ≥ 10%, and ≥ 20%. PD-L1 expression measured using IHC was assessed in 29 pre-treatment metastatic tumor samples using the mAb anti-PD-L1 clone 22C3 (Merck, Kenilworth, NJ). We obtained combined positive scores (CPS) for the assessment of PD-L1 positivity and considered CPS values ≥ 1 as positive (PD-L1 +). We also explored additional CPS cut-offs (≥ 5, ≥ 10, and ≥ 20).
The logistic and Cox regression models were used to evaluate the association of TILs density and PD-L1 expression with treatment efficacy in terms of ORR, CBR (with SD ≥ 24 weeks) and PFS according to the RECIST 1.1.
The logistic and Cox regression models were used to evaluate the association of TILs density and PD-L1 expression with treatment efficacy in terms of ORR, CBR (with SD ≥ 24 weeks) and PFS according to the RECIST 1.1.
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