替雷利珠单抗用于头颈癌患者的真实世界评估。
A real-world evaluation of tislelizumab in patients with head and neck cancer.
作者信息
Zheng Baomin, Huang Zhou, Liu Weixin, Zhao Dan, Xu Xiaolong, Xiao Shaowen, Sun Yan, Wang Weihu
机构信息
Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Beijing, China.
出版信息
Transl Cancer Res. 2024 Feb 29;13(2):808-818. doi: 10.21037/tcr-23-1502. Epub 2024 Feb 4.
BACKGROUND
Various studies support the use of programmed cell death protein 1 (PD-1) blockades, also known as immune checkpoint inhibitors (ICIs), to treat head and neck cancer (HNC). Tislelizumab is a humanised immunoglobulin G4 (IgG4) monoclonal antibody with a high affinity and specificity for PD-1. However, the "real-world" clinical evidence of tislelizumab for HNC is limited.
METHODS
In this study, the medical records of 39 patients with head and neck squamous cell carcinoma (HNSCC) or nasopharyngeal carcinoma (NPC) who received tislelizumab between January 2021 and March 2022 were reviewed retrospectively. Tislelizumab was administered to 15 patients during neoadjuvant therapy (Group 1), five patients during adjuvant therapy (Group 2), 14 patients during consolidation therapy (Group 3), and five patients during salvage therapy (Group 4). The Kaplan-Meier method was used to calculate progression-free survival (PFS) and overall survival (OS).
RESULTS
The median age of enrolled patients was 55 (range, 28-83) years. The median follow-up time was 27.1, 26.1, 28.6, and 20.9 months for Groups 1, 2, 3, and 4, respectively. The mean PFS and OS of Groups 1, 2, 3, and 4 were 21.5 and 22.8; 24.1 and 24.2; 26.9 and 28.1; and 13.9 and 17.1 months, respectively. In Groups 1 and 4, the objective response rate (ORR) was 86.7% and 60%, respectively. Meanwhile, except for one (2.6%) patient with grade 4 enteritis, the other observed non-haematological adverse events (AEs) were ≤ grade 2.
CONCLUSIONS
Tislelizumab demonstrated promising efficacy and tolerability in patients with HNSCC or NPC in a real-world setting, consistent with previous reports.
背景
多项研究支持使用程序性细胞死亡蛋白1(PD-1)阻断剂,即免疫检查点抑制剂(ICIs),来治疗头颈癌(HNC)。替雷利珠单抗是一种对PD-1具有高亲和力和特异性的人源化免疫球蛋白G4(IgG4)单克隆抗体。然而,替雷利珠单抗用于HNC的“真实世界”临床证据有限。
方法
在本研究中,回顾性分析了2021年1月至2022年3月期间接受替雷利珠单抗治疗的39例头颈部鳞状细胞癌(HNSCC)或鼻咽癌(NPC)患者的病历。15例患者在新辅助治疗期间接受替雷利珠单抗治疗(第1组),5例患者在辅助治疗期间接受治疗(第2组),14例患者在巩固治疗期间接受治疗(第3组),5例患者在挽救治疗期间接受治疗(第4组)。采用Kaplan-Meier方法计算无进展生存期(PFS)和总生存期(OS)。
结果
入组患者的中位年龄为55岁(范围28-83岁)。第1、2、3和4组的中位随访时间分别为27.1、26.1、28.6和20.9个月。第1、2、3和4组的平均PFS和OS分别为21.5和22.8;24.1和24.2;26.9和28.1;以及13.9和17.1个月。在第1组和第4组中,客观缓解率(ORR)分别为86.7%和60%。同时,除1例(2.6%)4级肠炎患者外,其他观察到的非血液学不良事件(AE)均≤2级。
结论
在真实世界中,替雷利珠单抗在HNSCC或NPC患者中显示出有前景的疗效和耐受性,与先前报告一致。