Isaku Okamoto1, Hiroki Sato1, Takahito Kondo2, Nobuyuki Koyama3, Chihiro Fushimi4, Takuro Okada4, Kouki Miura4, Takashi Matsuki5, Taku Yamashita5, Go Omura6, Kiyoaki Tsukahara1. 1. Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University , Tokyo , Japan. 2. Department of Otolaryngology, Head and Neck Surgery, Tokyo Medical University Hachioji Medical Center , Hachioji , Japan. 3. Department of Clinical Oncology, Tokyo Medical University Hachioji Medical Center , Hachioji , Japan. 4. Department of Head and Neck Oncology and Surgery, International University of Health and Welfare Mita Hospital , Tokyo , Japan. 5. Department of Otorhinolaryngology, Head and Neck Surgery, Kitasato University School of Medicine , Kanagawa , Japan. 6. Department of Head and Neck Surgery, National Cancer Center Hospital , Tokyo , Japan.
Abstract
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.
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.