Zhang Ximei, Wang Peiguo, Chai Yanlan, Zhou Xuan, Li Ping, Wang Xudong
Department of Radiation Oncology, Cancer Institute and Hospital, Tianjin Medical University, Tianjin, PR China.
Department of Radiation Oncology, Cancer Institute and Hospital, Tianjin Medical University, Tianjin, PR China.
Am J Otolaryngol. 2024 Jan-Feb;45(1):104065. doi: 10.1016/j.amjoto.2023.104065. Epub 2023 Oct 12.
Immune checkpoint inhibitors (ICIs) have become a standard therapy for recurrent or metastatic head and neck squamous cell carcinoma (R/MHNSCC), however, there are still unanswered questions about immunotherapy. Furthermore, immunotherapy for R/MHNSCC of the mainland Chinese population are lacking. The aim of this study is to evaluate the efficacy and safety of ICIs in real-world settings in China.
We retrospectively reviewed 59 patients with R/MHNSCC who received immunotherapy between May 2019 and December 2021. We assessed demographics, efficacy, survival and safety.
Fifty-nine patients were included in the study, all of whom had R/MHNSCC affecting the oral cavity, oropharynx, hypopharynx, larynx, nasal cavity, paranasal sinuses and metastatic cancer in the neck with an unknown primary. The objective response rate (ORR) for all patients was found to be 40.6 %. Out of these patients, 11 patients achieved a complete response and 13 achieved a partial response. The median progression-free survival (PFS) was calculated to be 10.64 months (range: 1.15-29.24 months), while the median overall survival (OS) was 21.75 months (range 2.0-37.55 months). The addition of local radiotherapy resulted in higher ORR and PFS compared to previous reports. Notably, patients with R/MHNSCC in the paranasal sinuses and nasal cavity also showed benefits from immunotherapy. Additionally, patients who achieved stable disease (SD) had similar survival rates to those who achieved partial response (PR), indicating that SD is also an indicator of clinical benefit from immunotherapy. The overall incidence of immune-related adverse reactions in this study was low, with fatigue and rash being the most common side effects.
These findings highlight the effectiveness and safety of immunotherapy for R/MHNSCC in a real-world setting in China. Further investigation is warranted to explore the potential benefits of incorporating local radiotherapy into the treatment of R/MHNSCC.
免疫检查点抑制剂（ICIs）已成为复发或转移性头颈部鳞状细胞癌（R/MHNSCC）的标准治疗方法，然而，关于免疫治疗仍有一些未解决的问题。此外，针对中国大陆人群的R/MHNSCC免疫治疗尚缺乏相关研究。本研究的目的是评估ICIs在中国真实世界环境中的疗效和安全性。
我们回顾性分析了2019年5月至2021年12月期间接受免疫治疗的59例R/MHNSCC患者。我们评估了患者的人口统计学特征、疗效、生存率和安全性。
59例患者纳入本研究，所有患者均患有R/MHNSCC，累及口腔、口咽、下咽、喉、鼻腔、鼻窦以及颈部转移性癌且原发灶不明。所有患者的客观缓解率（ORR）为40.6%。其中，11例患者达到完全缓解，13例达到部分缓解。中位无进展生存期（PFS）为10.64个月（范围：1.15 - 29.24个月），而中位总生存期（OS）为21.75个月（范围2.0 - 37.55个月）。与既往报道相比，联合局部放疗导致更高的ORR和PFS。值得注意的是，鼻窦和鼻腔R/MHNSCC患者也从免疫治疗中获益。此外，病情稳定（SD）的患者与部分缓解（PR）的患者生存率相似，表明SD也是免疫治疗临床获益的一个指标。本研究中免疫相关不良反应的总体发生率较低，疲劳和皮疹是最常见的副作用。
这些发现凸显了免疫治疗在中国真实世界环境中对R/MHNSCC的有效性和安全性。有必要进一步研究探索将局部放疗纳入R/MHNSCC治疗的潜在益处。
