Real-World, Long-Term Outcomes of Nivolumab Therapy for Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck and Impact of the Magnitude of Best Overall Response: A Retrospective Multicenter Study of 88 Patients.

Takashi Matsuki,Kenji Hanyu,Tatsuo Masubuchi,Kouki Miura,Hideaki Takahashi,Daisuke Kawakita,Kiyoaki Tsukahara,Hiroki Sato,Go Omura,Chihiro Fushimi,Takuro Okada,Isaku Okamoto,Kunihiko Tokashiki,Yuichiro Tada,Takahito Kondo,Taku Yamashita,Michi Sawabe,Tatsuya Ito

doi:10.3390/cancers12113427

Abstract

Simple SummaryNo real-world, long-term outcomes of immunotherapy with nivolumab for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) have yet been reported. Furthermore, the prognostic impact of the best overall response (BOR) of this therapy remains unclear. We conducted a multi-institutional cohort study of the long-term efficacy and safety of this therapy. We also evaluated the relationship between BOR and survival. Median follow-up time was 25.9 months. Median overall survival (OS) was 9.6 months, and two-year survival rate was 25.0%. Overall response rate was 18%, and disease control rate was 48%. For immune-related adverse events (irAEs), 38 irAEs were detected in 29 patients. The development of irAEs and better BOR were significantly associated with longer survival. These findings demonstrate the long-term efficacy and safety of nivolumab therapy for R/M SCCHN in a real-world setting. The magnitude of BOR and the development of irAEs might be useful surrogate markers of survival.No real-world, long-term outcomes of immunotherapy with nivolumab for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) have yet been reported. Furthermore, the prognostic impact of the best overall response (BOR) of this therapy remains unclear. We conducted a multi-institutional cohort study of the long-term efficacy and safety of this therapy and investigated prognostic factors associated with survival. Further, we evaluated the relationship between BOR and survival. Median follow-up time was 25.9 months. Median overall survival (OS) was 9.6 months, and two-year survival rate was 25.0%. Median progression-free survival (PFS) was 3.7 months, and two-year PFS rate was 19.6%. BOR was assessed as complete response (CR) in 6%, partial response (PR) in 13%, stable disease (SD) in 30%, and progressive disease (PD) in 52% of the patients. Overall response rate was 18%, and disease control rate was 48%. For immune-related adverse events (irAEs), 38 irAEs were detected in 29 patients. On multivariate analysis, the development of irAEs was significantly associated with better OS and PFS. Better BOR was significantly associated with longer OS and PFS. These findings demonstrate the long-term efficacy and safety of nivolumab therapy for R/M SCCHN in a real-world setting. The magnitude of BOR and the development of irAEs might be useful surrogate markers of survival.

Highlights

The prognosis of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) is poor
Eighty-eight consecutive patients with R/M SCCHN were treated with nivolumab and enrolled during the study period
R/M SCCHN originating in the nasopharynx, paranasal sinus, salivary gland, and external auditory canal and included patients without platinum refractoriness

Summary

Introduction

The prognosis of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) is poor. Treatment commonly involves platinum-based regimens, but the rate of severe adverse events with these agents is high; these include renal dysfunction and bone marrow suppression, and most patients require hospitalization. An anti-programmed death 1 (PD-1) monoclonal antibody, is an immune checkpoint inhibitor (ICI). Efficacy of nivolumab in R/M SCCHN was demonstrated in a phase 3 trial Nivolumab was approved for recurrent or metastatic head and neck cancer (R/M HNC). Previous number of chemotherapy regimens two or more (Ref. 1).

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