Abstract
In CheckMate 141, a randomized, phase 3 trial, nivolumab demonstrated superior overall survival(OS)in patients with recurrent or metastatic squamous cell carcinoma of the head and neck compared with the investigator’s treatment of choice. However, patients with non-squamous cell carcinoma or nasopharyngeal cancer were excluded from this trial. This retrospective study evaluated 28 patients with head and neck cancer who received nivolumab at the Osaka International Cancer Institute. In this retrospective analysis, nine had nasopharyngeal cancer and two had non-squamous cell carcinoma. Median progression-free survival (PFS) was 4.3 months (95% CI: 1.9-5.2) and median OS was not reached (95% CI: 7.8-NA). Of the 24 patients who had one or more target lesions, the response rate was 16.7%, and the disease control rate was 54.2%. The incidence of immune-related adverse events (irAE) was 46.4% (13 patients) for all grades, and 7.1% (2 patients) for grade 3. The PFS among patients with irAE was longer than that among patients without irAE. Although this retrospective study included patients with non-squamous cell carcinoma or nasopharyngeal cancer, nivolumab monotherapy demonstrated a comparable efficacy with the results of CheckMate 141.