Real-world Outcomes in Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck With Nivolumab: Galician Study

Background/Aim: Real-world evidence regarding the use of nivolumab in metastatic squamous cell carcinoma of head and neck (R/M SCCHN) is limited. This study aimed to describe the clinical characteristics, outcomes, and safety of nivolumab in R/M SCCHN patients treated in routine clinical practice.

Patients and Methods: This retrospective, observational study evaluated the efficacy/safety of nivolumab in 116 patients with R/M SCCHN treated at nine centers within the Galician Group of Head and Neck Cancer health network between 2017 and 2019.

Results: Basal characteristics of patients included a median age of 60 years, ECOG performance status −2 (14%) and −3 (1%) and a first diagnosis of stage IV a/b/c (74%). Nivolumab was used as first line, second line, and third line therapy in 17%, 66%, and 17% of patients, respectively. After a median follow-up of 14 months (range=1-69 months), the median progression-free survival was 2.30 months (95%CI=1.45-3.14) and the median overall survival was 8.1 months (95%CI=5.93-10.23). Outcomes were better when nivolumab was administered earlier in treatment course. Grade 3/4 adverse events were observed in 21.27% of patients.

Conclusion: These findings support the efficacy and safety of nivolumab in the real-world treatment of R/M SCCHN.