纳武利尤单抗治疗铂类耐药和敏感的复发性和转移性头颈部鳞状细胞癌。

Nivolumab for Platinum-refractory and -sensitive Recurrent and Metastatic Head and Neck Squamous Cell Carcinoma.

机构信息

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University, Tokyo, Japan;

Department of Otorhinolaryngology, Head and Neck Surgery, Kitasato University School of Medicine, Sagamihara, Japan.

出版信息

Anticancer Res. 2022 Oct;42(10):4907-4912. doi: 10.21873/anticanres.15996.

DOI:10.21873/anticanres.15996

PMID:36192003

Abstract

BACKGROUND/AIM: Nivolumab has antitumor efficacy in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) who relapse within 6 months after platinum-based therapy; however, the efficacy of nivolumab for platinum-sensitive R/M HNSCC has not been shown. Therefore, this study compared the efficacy and safety of nivolumab for platinum-refractory and platinum-sensitive R/M HNSCC.

PATIENTS AND METHODS

This was a retrospective study of patients who received nivolumab for R/M HNSCC who had been previously treated with platinum-based anticancer drugs. Patients were divided into a platinum-sensitive and a platinum-refractory group, and progression-free survival (PFS), overall survival (OS), the overall response rate (ORR) [complete response (CR) + partial response (PR)], the disease control rate (DCR) (CR + PR + stable disease), and the incidence of immune-related adverse events (irAEs) were compared between the two groups.

RESULTS

We included 88 patients with squamous cell carcinoma: 60 with platinum-refractory disease and 28 with platinum-sensitive disease. The median PFS in the platinum-refractory and platinum-sensitive groups were 2.7 months and 5.3 months, respectively (p=0.03), and the median OS were 8.8 months and 17.1 months, respectively (p=0.06). There were no significant differences in the ORR, DCR, or incidence of irAEs between the two groups (p>0.99, p=0.11, and p>0.99, respectively).

CONCLUSION

Nivolumab is a safe and effective treatment for platinum-sensitive R/M HNSCC.

摘要

背景/目的：纳武利尤单抗在铂类治疗后 6 个月内复发/转移性头颈部鳞状细胞癌（R/M HNSCC）患者中具有抗肿瘤疗效；然而，纳武利尤单抗在铂类敏感的 R/M HNSCC 中的疗效尚未得到证实。因此，本研究比较了纳武利尤单抗治疗铂类耐药和铂类敏感的 R/M HNSCC 的疗效和安全性。

患者和方法

这是一项回顾性研究，纳入了先前接受过铂类抗癌药物治疗的 R/M HNSCC 患者接受纳武利尤单抗治疗。患者分为铂类敏感组和铂类耐药组，比较两组间无进展生存期（PFS）、总生存期（OS）、总缓解率（ORR）[完全缓解（CR）+部分缓解（PR）]、疾病控制率（DCR）（CR+PR+稳定疾病）和免疫相关不良事件（irAE）的发生率。

结果

共纳入 88 例鳞状细胞癌患者：60 例铂类耐药，28 例铂类敏感。铂类耐药组和铂类敏感组的中位 PFS 分别为 2.7 个月和 5.3 个月（p=0.03），中位 OS 分别为 8.8 个月和 17.1 个月（p=0.06）。两组间 ORR、DCR 和 irAE 发生率无显著差异（p>0.99，p=0.11 和 p>0.99，分别）。