We retrospectively studied patients with recurrent or metastatic head and neck cancer who started pembrolizumab monotherapy or combination therapy between 2019 and 2021 in our institution to evaluate the efficacy and safety of the treatment. This study included 39 patients, of which 8 (21%) were 80 years or older. Of the participants enrolled, 21 had CPS≥20, 13 had CPS 1-19, and 5 had CPS<1. The BOR for monotherapy was CR 14%, PR 23%, SD 23%, and PD 41% with a response rate of 36%, and the response rate by CPS was 36% for CPS≥20, 50% for CPS 1-19, and 0% for CPS<1. The BOR for combination therapy was CR 29%, PR 24%, SD 24%, and PD 24% with a response rate of 53%, and the response rate by CPS was 71% for CPS≥20, 43% for CPS 1-19, and 33% for CPS<1. The 1-/2-year survival rates were 66/40% for overall, 63/48% for monotherapy, and 71/32% for combination therapy. The median overall survival was 17.2 months in all groups. The median overall survival by CPS was 25.4 months in CPS≥20, 15.5 months in CPS 1-19, and 14.9 months in
CPS<1. Thirteen patients had irAE (grade 4 in 1, and grade 3 in 1). Patients with irAE had a better response rate (67 vs. 33%) and survival rate (83 vs. 59% at 2 years) than those without irAE. In patients aged 80 years or older, both the median duration of treatment and the median overall survival were longer than those of the overall population, suggesting that the treatment was well tolerated.
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