<div>Aim </div><div>Assess the effectiveness and safety of nivolumab versus cetuximab in
patients with R/M HNSCC, as well as to analyze possible prognostic
factors for response to treatment with nivolumab. </div><div>Methods </div><div>We conducted
an observational, retrospective, descriptive study of patients with R/M
HNSCC who initiated treatment with nivolumab or cetuximab monotherapy in
two periods of equivalent duration. Overall efficacy was measured in
progression-free survival (PFS) and overall survival (OS); safety was
evaluated using the CTCAE (Common Terminology Criteria for Adverse
Events) classification version 5.0 of the National Cancer Institute
(NCI). </div><div>Results </div><div>Median overall survival (OS) was 9.1 months with
nivolumab (n=34) vs. 6.3 months with cetuximab (n=12)(HR=0.5; 95%CI:
0.24-1.03; p=0.058). Progression free survival (PFS) were 4.3 for
nivolumab and 4.65 months for cetuximab (HR=0.59; 95%CI: 0.29-1.19;
p=0.14). Any grade adverse events (AEs) were reported in 97% and 100%
of the patients treated with nivolumab and cetuximab. Serious AEs were
observed in 26% and 58% of the patients respectively. Elevated albumin
values, lymphocytosis, neutropenia and elevated neutrophil/lymphocyte
ratio values have positive prognostic value on the response to nivolumab
in R/M CCECC. </div><div>Conclusion </div><div>Effectiveness of nivolumab in terms of OS
remains superior to cetuximab. OS, PFS and severe or any grade AEs were
superior in both arms of our study than in the clinical trials. The AEs
profile of nivolumab differs in our study from the clinical trials’
observations. We have identified four positive statistically significant
prognostic variables on the response to nivolumab in R/M HNSCC.</div>