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帕博利珠单抗治疗复发性或转移性头颈部癌患者的研究。

A Study of Patients with Recurrent or Metastatic Head and Neck Cancer Treated with Pembrolizumab.

机构信息

Department of Otolaryngology and Head and Neck Surgery, Tokai University, School of Medicine, 143 Shimokasuya, Isehara, Kanagawa, 259-1193 Japan.

出版信息

Tokai J Exp Clin Med. 2022 Sep 20;47(3):99-104.

Abstract

BACKGROUND/AIM: In December 2019, pembrolizumab was approved in Japan for the treatment of head and neck cancer with recurrence or distant metastasis, making it a new option for first-line treatment. However, there are still many unanswered questions about Overall survival (OS), Progression free survival (PFS), adverse events including immune-related adverse events (irAEs), and biomarkers.

AIMS/OBJECTIVES: The aim of this study was to retrospectively review first-line treatment of head and neck cancer with recurrence or distant metastasis treated with pembrolizumab and to determine whether Combined positive score (CPS) is still useful as a biomarker in the clinical practice.

MATERIAL AND METHODS

We retrospectively reviewed clinical records of 20 patients who received pembrolizumab as first-line treatment for head and neck cancer with recurrence or distant metastasis between December 2019 and March 2021.

RESULTS

Age ranged from 45 to 83 years (median 66 years), 17 male patients and 3 female patients. The response rate was 40%, and the disease control rate was 60%. OS and PFS in patients with CPS < 1 were significantly worse than those with CPS ≤ 1 (CPS-positive patients). The OS and PFS of patients with CPS < 1 were s ignificantly worse than those of p atients with 1 < = CPS (CPS-positive p atients), and there was no significant difference between the group with CPS between 1 and 20 and the group with CPS over 20. And we experiences several CR cases with high CPS.

CONCLUSION

CPS is a useful biomarker for pembrolizumab.

SIGNIFICANCE

There are no reported cases of CR after two courses of pembrolizumab in head and neck cancer. There are no reports of pembrolizumab in patients with head and neck cancer in Japan.

摘要

背景/目的:2019 年 12 月,帕博利珠单抗在日本获批用于治疗复发或远处转移的头颈部癌,成为一线治疗的新选择。然而,关于总生存期(OS)、无进展生存期(PFS)、包括免疫相关不良事件(irAEs)在内的不良事件以及生物标志物等仍有许多未解决的问题。

目的/目标:本研究旨在回顾性分析复发或远处转移的头颈部癌患者一线使用帕博利珠单抗治疗的情况,并确定联合阳性评分(CPS)作为生物标志物在临床实践中的应用是否仍然有效。

材料和方法

我们回顾性分析了 2019 年 12 月至 2021 年 3 月期间接受帕博利珠单抗一线治疗复发或远处转移的头颈部癌患者的临床记录。

结果

年龄 45-83 岁(中位年龄 66 岁),男性 17 例,女性 3 例。客观缓解率为 40%,疾病控制率为 60%。CPS<1 的患者的 OS 和 PFS 明显差于 CPS≤1 的患者(CPS 阳性患者)。CPS<1 的患者的 OS 和 PFS 明显差于 CPS>1 的患者(CPS 阳性患者),而 CPS 在 1-20 之间的患者与 CPS 超过 20 的患者之间无显著差异。我们还经历了几例 CPS 较高的 CR 病例。

结论

CPS 是帕博利珠单抗的有用生物标志物。

意义

在头颈部癌中,两周期帕博利珠单抗后报告的 CR 病例没有。在日本,也没有关于头颈部癌患者使用帕博利珠单抗的报告。

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