Efficacy and safety of nivolumab in 100 patients with recurrent or metastatic head and neck cancer – a retrospective multicentre study

Abstract

Background: No large-scale retrospective studies have examined the efficacy and safety of nivolumab.

Objective: This retrospective study aimed to investigate the efficacy and safety of nivolumab administered to patients in multiple facilities.

Material and methods: The primary endpoint was overall response rate (ORR) and secondary endpoints were progression-free survival (PFS) and overall survival (OS). For safety, adverse event occurrence rates by grade, deaths and severe adverse events were investigated. OS and PFS were also examined according to whether immune-related adverse events (irAEs) appeared. Statistical analysis was conducted using log-rank testing, with values of p < .05 considered significant.

Results: Nivolumab was administered to 100 patients with a history of receiving platinum-based drugs. ORR was 13.5% and disease control rate was 49.0%. Median PFS was 3.7 months. Median OS was 9.6 months. For all grades, irAEs occurred in 30 patients. The 1-year survival rate in the subgroup without irAEs was 34.0%, compared to 52.6% with irAEs (p = .041).

Conclusions and significance: The 1-year survival rate was better in patients who developed irAEs. This is a new finding for head and neck cancer. Appearance of irAEs could also be used as an indicator of expected therapeutic effect in head and neck cancer.

背景：还没有大规模的回顾性研究检验过Nivolumab的有效性和安全性。

目的：本回顾性研究旨在调查在多个医疗机构中患者所接受的Nivolumab的有效性和安全性。

材料和方法：主要终点是总体反应率（ORR）, 次要终点是无进展生存期（PFS）和总生存期（OS）。为安全起见, 研究了不同级别、死亡和严重不良事件的不良事件发生率。还根据是否出现免疫相关不良事件（irAE）来检测OS和PFS。使用对数秩检验进行统计学分析, p <.05的值被认为是显着的。

结果：对100名接受过铂类药物治疗的患者进行Nivolumab给药。 ORR为13.5％, 疾病控制率为49.0％。中位PFS为3.7个月。中位OS为9.6个月。对于所有级别, irAE发生于30名患者。没有irAE的亚组的1年生存率为34.0％, 而irAE亚组为52.6％（p = .041）。

结论和意义：发生irAE的患者的1年生存率更高。这是关于头颈癌的新发现。 irAE的出现也可用作头颈癌预期治疗效果的指标。

Keywords:

• Nivolumab
• multicentre clinical study
• overall response rate
• progression-free survival
• overall survival
• immune-related adverse events

Disclosure statement

The authors report no conflict of interest.