CC BY-NC-ND 4.0 · International Journal of Practical Otolaryngology 2019; 02(01): e7-e10
DOI: 10.1055/s-0039-1685175
Original Article
Georg Thieme Verlag KG Stuttgart · New York

Nivolumab in the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (RM-SCCHN): A Report of 16 Cases at a Single Institution

Tomoko Yamazaki
1   Division of Head and Neck Medical Oncology, Miyagi Cancer Center, Medeshima, Natori, Miyagi, Japan
,
Jiro Aoi
2   Division of Head and Neck Medical Surgery, Miyagi Cancer Center, Medeshima, Natori, Miyagi, Japan
,
Kazutaka Kishimoto
2   Division of Head and Neck Medical Surgery, Miyagi Cancer Center, Medeshima, Natori, Miyagi, Japan
,
Satoshi Saijo
2   Division of Head and Neck Medical Surgery, Miyagi Cancer Center, Medeshima, Natori, Miyagi, Japan
,
Keitaro Fujii
2   Division of Head and Neck Medical Surgery, Miyagi Cancer Center, Medeshima, Natori, Miyagi, Japan
,
Takayuki Imai
2   Division of Head and Neck Medical Surgery, Miyagi Cancer Center, Medeshima, Natori, Miyagi, Japan
,
Yukinori Asada
2   Division of Head and Neck Medical Surgery, Miyagi Cancer Center, Medeshima, Natori, Miyagi, Japan
,
Kazuto Matsuura
2   Division of Head and Neck Medical Surgery, Miyagi Cancer Center, Medeshima, Natori, Miyagi, Japan
› Author Affiliations
Further Information

Publication History

12 November 2018

18 January 2019

Publication Date:
03 April 2019 (online)

Abstract

Background Nivolumab, approved in Japan for platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (RM-SCCHN) in 2017, is of uncertain cost-effectiveness.

Patients and Methods We reviewed the data of 16 patients with platinum-refractory RM-SCCHN treated with nivolumab monotherapy, 3 mg/kg every 2 weeks, between April 2017 and February 2018.

Results All 16 patients were male. The number of previous treatments was 1, 2, and 3 in 1, 5, and 10 patients, respectively. All patients had been previously treated with regimens that included platinum, and 15 patients had previously received cetuximab. The best response rate was a partial response in two patients. Stable disease occurred in 11 patients and disease progression occurred in 2 patients. The disease control rate was 81.2%. Median follow-up time was approximately 8.7 months, and median progression-free survival (PFS) was 2.1 months. Adverse events (AEs) ≤ Grade 3 included pneumonitis and rash in 38%, pruritus in 31%, fatigue in 25%, and kidney dysfunction and endocrine disorder in 12% each. AEs > Grade 3 included pruritus in 12%, and pneumonitis in 6%. Drug discontinuation was requested by patients' clinicians for disease progression in seven patients and Grade 3 AEs in three. Following nivolumab treatment, seven patients received salvage treatment.

Conclusion Nivolumab showed some efficacy in disease control, but PFS was low. The AE rate was acceptable, with no Grade 4 or 5. If patient selection can be fine-tuned, treatment with this agent may become cost-effective.

 
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