Real-world Data Study of the Efficacy and Toxicity of Nivolumab vs. Cetuximab and Predictors of Response to Nivolumab in Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck in a European Population

Background/Aim: This study aimed to assess the effectiveness and safety of nivolumab versus cetuximab in patients with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M HNSCC), as well as to analyze possible prognostic factors for response to treatment with nivolumab. Patients and Methods: 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 terms of progression-free survival (PFS) and overall survival (OS). Safety was evaluated using the Common Terminology Criteria for Adverse Events classification version 5.0 of the National Cancer Institute. Results: Median OS was 9.1 months with nivolumab (n=34) and 6.3 months with cetuximab (n=12). PFS was 4.3 months for nivolumab and 4.65 months for cetuximab. 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 were found to have positive prognostic value on the response to nivolumab in R/M HNSCC. Conclusion: 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 compared