Abstract

Nivolumab, an immune checkpoint inhibitor, is beneficial to patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma (R/M-HNSCC). However, platinum-sensitive R/M-HNSCC has not yet been studied. Hence, in this prospective study, we evaluated the efficacy and safety of nivolumab in patients with platinum-sensitive R/M-HNSCC. This prospective single-arm study was conducted in a single institution in Japan. Patients with platinum-sensitive R/M-HNSCC (defined as head and neck cancer that recurred or metastasized at least 6 months after platinum-based chemotherapy or chemoradiotherapy) were enrolled. The primary endpoint was overall survival (OS). The secondary endpoints were progression-free survival (PFS), overall response rate (ORR), immune-related adverse events (irAEs), and quality of life (QOL). This study was registered at the University Hospital Medical Information Network Clinical Trials Registry (UMIN000031324). Twenty-two patients with platinum-sensitive R/M-HNSCC were enrolled. The median OS was 17.4 months, and the 1-year OS rate was 73%. The median PFS was 9.6 months, 1-year PFS rate was 48%, and ORR was 36%. Sixteen irAEs were recorded in 12 patients; however, no grade 4 or 5 irAEs were observed. The QOL assessments revealed that nivolumab did not decrease the QOL of patients. Nivolumab is effective against platinum-sensitive R/M-HNSCC with acceptable safety.

Highlights

  • Nivolumab, an immune checkpoint inhibitor, is beneficial to patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma (R/M-HNSCC)

  • The main outcomes of this study were the median overall survival (OS) of 17.4 months, median progression-free survival (PFS) of 9.6 months, overall response rate (ORR) of 36%, and disease control rate (DCR) of 68%

  • The number of patients in the study by primary site was too small to ensure the certainty of the results, there was no clear effect of the primary site on efficacy

Read more

Summary

Introduction

An immune checkpoint inhibitor, is beneficial to patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma (R/M-HNSCC). Platinumsensitive R/M-HNSCC has not yet been studied In this prospective study, we evaluated the efficacy and safety of nivolumab in patients with platinum-sensitive R/M-HNSCC. Patients with platinum-sensitive R/M-HNSCC (defined as head and neck cancer that recurred or metastasized at least 6 months after platinum-based chemotherapy or chemoradiotherapy) were enrolled. In the CheckMate-141 study, treatment with nivolumab led to a median OS of 7.5 months, median progression-free survival (PFS) of 2.04 months, and an overall response rate (ORR) of 13.3%4. CheckMate-141 only enrolled patients with platinum-refractory R/M-HNSCC, and no prospective study has been conducted on the efficacy and safety of nivolumab for platinum-sensitive R/M-HNSCC. The aim of this study was to prospectively evaluate the efficacy and safety of nivolumab in patients with platinum-sensitive R/M-HNSCC

Objectives
Methods
Results
Conclusion
Full Text
Published version (Free)

Talk to us

Join us for a 30 min session where you can share your feedback and ask us any queries you have

Schedule a call