帕博利珠单抗治疗复发或转移性头颈部鳞状细胞癌患者的临床结局：一项中国单中心真实世界研究。
The clinical outcome of pembrolizumab for patients with recurrent or metastatic squamous cell carcinoma of the head and neck: a single center, real world study in China.
作者信息
Fan Zongyu, Hui Rongrong, Ju Houyu, Wu Yunteng, Ma Xuhui, Song Hao, Liu Yang, Rui Mengyu, Geng Xinrong, Zhao Minqi, Xin Yingye, Wei Dongliang, Ren Guoxin
机构信息
Department of Oral Maxillofacial-Head and Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Shanghai Key Laboratory of Stomatology & Shanghai Research Institute of Stomatology, National Clinical Research Center of Stomatology, Shanghai, China.
出版信息
Front Oncol. 2024 Feb 19;14:1360657. doi: 10.3389/fonc.2024.1360657. eCollection 2024.
BACKGROUND
The KEYNOTE-048 and KEYNOTE-040 study have demonstrated the efficacy of pembrolizumab in recurrent or metastatic squamous cell carcinoma of the head and neck (R/M HNSCC), we conducted this real-world study to investigate the efficacy of pembrolizumab in patients with R/M HNSCC.
METHODS
This is a single-center retrospective study conducted in the Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Shanghai, China). Between December 2020 and December 2022, a total of 77 patients with R/M HNSCC were included into analysis. The primary endpoint of the study was overall survival (OS), and the secondary endpoints were progression-free survival (PFS), overall response rate (ORR)and toxicity.Efficacy was assessed according to RECIST version 1.1.SPSS 27.0 and GraphPad Prism 8.0 software were utilized to perform the statistical analysis.
RESULTS
By the cut-off date (February 28, 2023), the median OS,PFS and ORR were 15.97 months,8.53 months and 48.9% in patients treated with the pembrolizumab regimen in the first line therapy. Among these patients, 17 patients received pembrolizumab with cetuximab,and 18 received pembrolizumab with chemotherapy.We observed no significant differences between two groups neither in median OS (13.9 vs 19.4 months, P=0.3582) nor PFS (unreached vs 8.233 months, P= 0.2807). In the ≥2nd line therapy (n=30), the median OS, PFS and ORR were 5.7 months, 2.58 months and 20% respectively. Combined positive score (CPS) was eligible from 54 patients. For first line therapy, the median OS and PFS were 14.6 and 8.53 months in patients with CPS ≥1, and median OS and PFS were 14.6 and 12.33 months in patients with CPS ≥20. The immune-related adverse events (irAEs) were occurred in the 31 patients (31/77, 40.26%), and the most common potential irAEs were hypothyroidism (25.97%), and pneumonitis (7.79%).
CONCLUSION
Our real-world results indicated that pembrolizumab regimen is a promising treatment in patients with R/M HNSCC.
背景
KEYNOTE-048和KEYNOTE-040研究已证明帕博利珠单抗在复发或转移性头颈部鳞状细胞癌（R/M HNSCC）中的疗效，我们开展了这项真实世界研究，以调查帕博利珠单抗在R/M HNSCC患者中的疗效。
方法
这是一项在上海交通大学医学院附属第九人民医院（中国上海）进行的单中心回顾性研究。2020年12月至2022年12月期间，共有77例R/M HNSCC患者纳入分析。研究的主要终点为总生存期（OS），次要终点为无进展生存期（PFS）、总缓解率（ORR）和毒性。根据RECIST 1.1版评估疗效。使用SPSS 27.0和GraphPad Prism 8.0软件进行统计分析。
结果
截至截止日期（2023年2月28日），一线治疗接受帕博利珠单抗方案的患者的中位OS、PFS和ORR分别为15.97个月、8.53个月和48.9%。在这些患者中，17例患者接受帕博利珠单抗联合西妥昔单抗治疗，18例接受帕博利珠单抗联合化疗。我们观察到两组之间在中位OS（13.9 vs 19.4个月，P = 0.3582）和PFS（未达到 vs 8.233个月，P = 0.2807）方面均无显著差异。在≥二线治疗（n = 30）中，中位OS、PFS和ORR分别为5.7个月、2.58个月和20%。54例患者可获得联合阳性评分（CPS）。对于一线治疗，CPS≥1的患者的中位OS和PFS分别为14.6个月和8.53个月，CPS≥20的患者的中位OS和PFS分别为14.6个月和12.33个月。31例患者（31/77，40.26%）发生免疫相关不良事件（irAE），最常见的潜在irAE为甲状腺功能减退（25.97%）和肺炎（7.79%）。
结论
我们的真实世界研究结果表明，帕博利珠单抗方案对R/M HNSCC患者是一种有前景的治疗方法。
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