耳鼻咽喉科臨床
Online ISSN : 1884-4545
Print ISSN : 0032-6313
ISSN-L : 0032-6313
二次出版
再発/転移性頭頸部扁平上皮癌(RM-SCCHN)の治療におけるニボルマブの役割
―16例の経験―
山﨑 知子西條 聡藤井 慶太郎今井 隆之浅田 行紀松浦 一登
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2019 年 112 巻 9 号 p. 625-628

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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%. The median follow-up time was approximately 8.7 months, and the median progression-free survival (PFS) was 2.1 months. Adverse events (AE) ≤Grade 3 included pneumonitis and rash in 38%, pruritus in 31%, fatigue and kidney dysfunction in 25% 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 the PFS was low. The AE rate was acceptable, with no Grade 4 or 5 AEs. If patient selection can be fine-tuned, treatment with this agent may become cost-effective.

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