Efficacy and safety of nivolumab in 100 patients with recurrent or metastatic head and neck cancer - a retrospective multicentre study.

Background: No large-scale retrospective studies have examined the efficacy and safety of nivolumab. Objective: This retrospective study aimed to investigate the efficacy and safety of nivolumab administered to patients in multiple facilities. Material and methods: The primary endpoint was overall response rate (ORR) and secondary endpoints were progression-free survival (PFS) and overall survival (OS). For safety, adverse event occurrence rates by grade, deaths and severe adverse events were investigated. OS and PFS were also examined according to whether immune-related adverse events (irAEs) appeared. Statistical analysis was conducted using log-rank testing, with values of p < .05 considered significant. Results: Nivolumab was administered to 100 patients with a history of receiving platinum-based drugs. ORR was 13.5% and disease control rate was 49.0%. Median PFS was 3.7 months. Median OS was 9.6 months. For all grades, irAEs occurred in 30 patients. The 1-year survival rate in the subgroup without irAEs was 34.0%, compared to 52.6% with irAEs (p = .041). Conclusions and significance: The 1-year survival rate was better in patients who developed irAEs. This is a new finding for head and neck cancer. Appearance of irAEs could also be used as an indicator of expected therapeutic effect in head and neck cancer.