Abstract
BackgroundWe have previously reported the effectiveness and safety of nivolumab in patients with head and neck cancer (HNC) in real-world clinical practice in Japan. Here, we report long-term outcomes from this study in the overall population and subgroups stratified by subsequent chemotherapy.MethodsIn this multicenter, retrospective observational study, Japanese patients with recurrent or metastatic (R/M) HNC receiving nivolumab were followed up for 2 years. Effectiveness endpoints included overall survival (OS), OS rate, progression-free survival (PFS), and PFS rate. Safety endpoints included the incidence of immune-related adverse events (irAEs).ResultsOverall, 256 patients received a median of 6.0 doses (range: 1–52) of nivolumab over a median duration of 72.5 days (range: 1–736). Median OS was 9.5 months [95% confidence interval (CI) 8.2–12.0] and median PFS was 2.1 months (95% CI 1.8–2.7). A significant difference between 2-year survivors (n = 62) and non-2-year survivors was observed by median age (P = 0.0227) and ECOG PS (P = 0.0001). Of 95 patients who received subsequent chemotherapy, 54.7% received paclitaxel ± cetuximab. The median OS and PFS from the start of paclitaxel ± cetuximab were 6.9 months (95% CI 5.9–11.9) and 3.5 months (95% CI 2.3–5.5), respectively. IrAEs were reported in 17.2% of patients. Endocrine (7.0%) and lung (4.3%) disorders were the most common irAEs; kidney disorder (n = 1) was newly identified in this follow-up analysis.ConclusionsResults demonstrated the long-term effectiveness of nivolumab and potential effectiveness of subsequent chemotherapy in patients with R/M HNC in the real-world setting. Safety was consistent with that over the 1-year follow-up.
Highlights
Nivolumab is a fully human immunoglobulin G4 monoclonal antibody that targets programmed cell death protein-1
Extended author information available on the last page of the article in the global phase 3 CheckMate 141 study in patients with recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) whose disease had progressed within 6 months after platinum-based chemotherapy [1]
Patients with R/M head and neck cancer (HNC) with disease progression on or after platinum-based therapy and who were treated with nivolumab at least once for the first time between Jul 1, 2017, and Dec 31, 2017, were included in the study, except those who had participated in a clinical trial assessing antineoplastic therapy [5]
Summary
Nivolumab is a fully human immunoglobulin G4 monoclonal antibody that targets programmed cell death protein-1. Nivolumab was approved in March 2017 in Japan for the treatment of unresectable recurrent or distant metastatic (R/M) head and neck cancer (HNC) that had progressed following chemotherapy. This approval was based on the survival benefits and manageable safety profile demonstrated. In the CheckMate 141 study, long-term (2-year) follow-up data were reported for the overall population [2], as well as for the Asian subpopulation [3]. Methods In this multicenter, retrospective observational study, Japanese patients with recurrent or metastatic (R/M) HNC receiving nivolumab were followed up for 2 years. Conclusions Results demonstrated the long-term effectiveness of nivolumab and potential effectiveness of subsequent chemotherapy in patients with R/M HNC in the real-world setting. Safety was consistent with that over the 1-year follow-up
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