Concurrent Cetuximab and Nivolumab as a Second-Line or beyond Treatment of Patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results of Phase I/II Study

摘要

To improve overall survival (OS), we evaluated a combination of cetuximab and nivolumab for toxicity and efficacy in patients with incurable recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC). In addition, electronic health record-derived real-world data were used to provide clinical context for our prospective findings and to explore sequential treatment effects of cetuximab and immune checkpoint inhibitors (CPI) including nivolumab and pembrolizumab. The cetuximab and nivolumab combination was very well tolerated. Although patients with no prior CPI showed a trend for more favorable progression-free survival relative to patients with prior CPI, the improvement in the 1-year OS did not reach the statistical threshold in this heavily treated patients. Optimal sequencing of cetuximab and CPI may have an impact in prognosis and requires further evaluation in management of patients with incurable HNSCC.