Abstract

Although immune-checkpoint inhibitors (ICIs) are effective against various cancers, little is known regarding their role in salivary gland carcinoma (SGC) treatment. Therefore, we evaluated the efficacy and safety of nivolumab monotherapy in patients with recurrent and/or metastatic SGC. In this multicentre retrospective study, nivolumab (240 mg) was administered every 2 weeks. The overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety were examined; the correlation between treatment outcomes and clinicopathological factors was analysed. Twenty-four patients were enrolled; the most common histopathology was salivary duct carcinoma. Eleven tumours were PD-L1-positive; no tumour was microsatellite instability-high. The ORR was 4.2%, and the median PFS and OS were 1.6 and 10.7 months, respectively. One patient continued nivolumab for 28 months without disease progression. One patient showed grade 4 increase in creatine phosphokinase levels and grade 3 myositis. Biomarker analysis revealed significantly increased OS in patients with performance status of 0; modified Glasgow prognostic score of 0; low neutrophil-to-lymphocyte ratio, lactate dehydrogenase, and C-reactive protein; and high lymphocyte-to-monocyte ratio and in patients who received systemic therapy following nivolumab. Although nivolumab’s efficacy against SGC was limited, some patients achieved long-term disease control. Further studies are warranted on ICI use for SGC.

Highlights

  • Immune-checkpoint inhibitors (ICIs) are effective against various cancers, little is known regarding their role in salivary gland carcinoma (SGC) treatment

  • Nivolumab was well tolerated by patients with SGC, and AEs associated with nivolumab was comparable with those associated with ­pembrolizumab24

  • Prospective studies on p­ embrolizumab24 and pembrolizumab combined with ­vorinostat25 reported that the overall response rate (ORR) of patients with multiple histopathological types of SGC was 12% and 16%, respectively, with the median progression-free survival (PFS) and overall survival (OS) of 4–6.9 and 13–14 months, respectively

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Summary

Introduction

Immune-checkpoint inhibitors (ICIs) are effective against various cancers, little is known regarding their role in salivary gland carcinoma (SGC) treatment. We evaluated the efficacy and safety of nivolumab monotherapy in patients with recurrent and/or metastatic SGC. In this multicentre retrospective study, nivolumab (240 mg) was administered every 2 weeks. Two studies on nivolumab in patients with non-HNSCC, including s­ ix and t­wo patients with SGC, respectively, have been published. SDC is reported to harbour a higher mutational burden than other types of ­SGC32,34,39–41 Overall, these findings suggest that ICIs may have a higher efficacy against SDCs than other histopathological types of SGCs

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