基于年龄的纳武利尤单抗治疗复发性或转移性头颈部鳞状细胞癌的疗效和安全性：一项多中心回顾性研究。

Age-based efficacy and safety of nivolumab for recurrent or metastatic head and neck squamous cell carcinoma: A multicenter retrospective study.

机构信息

Department of Otorhinolaryngology, Head and Neck Surgery, Tokyo Medical University Hachioji Medical Center, Hachioji, Tokyo, Japan.

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

出版信息

Asia Pac J Clin Oncol. 2020 Dec;16(6):340-347. doi: 10.1111/ajco.13374. Epub 2020 Jun 23.

DOI:10.1111/ajco.13374

PMID:32573033

Abstract

AIM

This study retrospectively investigated the efficacy and safety of nivolumab for patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC) classified using age <65 years as the cutoff.

METHODS

Overall, 88 patients with R/M HNSCC treated with nivolumab were classified into the young group (<65 years; n = 39) and elderly group (≥65 years; n = 49). Efficacy was evaluated using overall survival (OS), progression-free survival (PFS), overall response rate (ORR) and disease control rate (DCR). Safety was evaluated considering immune-related adverse events (irAEs).

RESULTS

The median OS was 9.7 and 8.6 months in the young and elderly groups, respectively. The 1-year OS rate was 42.0% and 29.4% in the young and elderly groups, respectively. The median PFS was 3.0 and 4.2 months in the young and elderly groups, respectively. The 1-year PFS rate was 30.0% and 27.9% in the young and elderly groups, respectively. In the young group, the ORR was 10.3% and DCR was 33.3%. In the elderly group, the ORR was 18.4% and DCR was 53.1%. There were no significant differences in OS, PFS, ORR, and DCR (P = 0.36, 0.53, 0.29 and 0.06, respectively). Interstitial lung disease (ILD) as an irAE occurred in the young group at a significantly higher rate (20.5% vs 4.1%; P = 0.02).

CONCLUSIONS

There were no significant differences in OS, PFS, ORR, and DCR between the young and elderly groups. DCR tended to be better in the elderly group (P = 0.06). ILD occurred at a significantly higher rate in the young group.

摘要

目的

本研究回顾性分析了以年龄<65 岁为界对接受纳武利尤单抗治疗的复发性或转移性头颈部鳞状细胞癌（R/M HNSCC）患者的疗效和安全性。

方法

共纳入 88 例接受纳武利尤单抗治疗的 R/M HNSCC 患者，分为年轻组（<65 岁；n=39）和老年组（≥65 岁；n=49）。采用总生存期（OS）、无进展生存期（PFS）、总缓解率（ORR）和疾病控制率（DCR）评价疗效。考虑免疫相关不良事件（irAEs）评价安全性。

结果

年轻组和老年组的中位 OS 分别为 9.7 个月和 8.6 个月。年轻组和老年组的 1 年 OS 率分别为 42.0%和 29.4%。年轻组和老年组的中位 PFS 分别为 3.0 个月和 4.2 个月。年轻组和老年组的 1 年 PFS 率分别为 30.0%和 27.9%。年轻组的 ORR 为 10.3%，DCR 为 33.3%。老年组的 ORR 为 18.4%，DCR 为 53.1%。两组 OS、PFS、ORR 和 DCR 比较，差异均无统计学意义（P=0.36、0.53、0.29、0.06）。年轻组间质性肺病（ILD）作为 irAE 的发生率明显高于老年组（20.5%比 4.1%；P=0.02）。