IL-6 as new prognostic factor in patients with advanced cutaneous squamous cell carcinoma treated with cemiplimab
Domenico Mallardo, Ester Simeone, Lucia Festino, Marilena Tuffanelli, Vito Vanella, Claudia Trojaniello, Maria Grazia Vitale, Margaret Ottaviano, Mariaelena Capone, Gabriele Madonna, Francesca Sparano, Eleonora Cioli, Luigi Scarpato, Marco Palla, Rossella Di Trolio, Paolo Meinardi, Corrado Caracò, Gerardo Ferrara, Paolo Muto, Ernesta Cavalcanti, Paolo A. Ascierto
Abstract
BACKGROUND: Prognostic factors for initial response of advanced cutaneous squamous cell carcinoma to cemiplimab treatment are lacking. Il-6 has been found to affect immune cell populations which impact tumor development. The aim was to investigate the prognostic significance of IL-6 serum levels before and during treatment. METHODS: Serum levels of IL-6 were correlated with clinical outcomes in a retrospective study. RESULTS: Overall, 39 patients were enrolled. High serum levels of IL-6 (> 5.6 pg/ml) were associated with poorer survival (45.1% vs 0 deaths; OS: 16.1 ± 1.5 vs 20.8 ± 0 months, 95% CI 13,046 to 19,184) and shorter PFS (10.3 ± 1.9 vs 18.9 ± 1.5 months; 95% CI 3433 to 10,133) in patients with advanced CSCC treated with cemiplimab. In addition, patients whose IL-6 level increased after treatment with cemiplimab, independently of the basal level, had a poorer response to treatment than patients whose level was reduced or stable after immunotherapy. CONCLUSIONS: Serum levels of IL-6 at baseline and changes after cemiplimab immunotherapy may have a prognostic significance in patients with advanced cutaneous squamous cell carcinoma.