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A multicenter, real-world study analysis: pembrolizumab changes treatment strategy for the patient with recurrent/metastatic head and neck squamous cell carcinoma

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机构: [1]Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong 250117, P.R. China. [2]Department of Head and Neck Radiotherapy, Liaoning Cancer Hospital & Institute, Shenyang, Liaoning 110042, P.R. China. [3]Cancer Center, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong 250021, P.R. China. [4]Department of Radiation Oncology, The First Hospital of China Medical University, Shenyang, Liaoning 110001, P.R. China. [5]Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, P.R. China. [6]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430022, P.R. China. [7]Department of Otorhinolaryngology Head and Neck Surgery, Yuhuangding Hospital, Qingdao University, Yantai, Shandong 264000, P.R. China. [8]Department of Radiation Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029, P.R. China. [9]Department of Radiation Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi 530021, P.R. China. [10]Department of Head and Neck Cancer Radiotherapy, Affiliated Cancer Hospital of Xinjiang Medical University, Urumqi, Xinjiang 830011, P.R. China. [11]Department of Radiotherapy, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi 710061, P.R. China. [12]Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangzhou, Guangdong 510060, P.R. China. [13]Department of Radiation Oncology, Chongqing University Cancer Hospital, Chongqing 400030, P.R. China. [14]Department of Radiation Oncology, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, University of Electronic Science and Technology of China, Chengdu, Sichuan 610041, P.R. China. [15]Department of Radiation Oncology, Hunan Cancer Hospital & The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, Hunan 410013, P.R. China. [16]Department of Radiation Oncology, The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, Henan 450008, P.R. China. [17]Department of Radiation Oncology, The First Affiliated Hospital of University of Science and Technology of China, Hefei, Anhui 230036, P.R. China. [18]Department of Oncology, Xiangya Hospital, Central South University, Changsha, Hunan 410008, P.R. China. [19]Department of Radiation Oncology, The First Affiliated Hospital of Xiamen University, Xiamen, Fujian 361003, P.R. China. [20]Department of Oral and Maxillofacial Surgery, Affiliated Hospital of Qingdao University, Qingdao, Shandong 266003, P.R. China. [21]Department of Radiation Oncology, Endocrine Service, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA. [22]Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong 250117, P.R. China.
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Anti-PD-1/PD-L1 has made breakthrough progress in the treatment of recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC). However, the Asian population in KEYNOTE-048 only accounts for 13.2% of the total population, and there is a lack of data on the mainland Chinese population. This multi-center trial (ChiCTR2400090060) evaluated the efficacy and safety of pembrolizumab in patients with R/M HNSCC. Between July 2020 and January 2024, 291 patients who received pembrolizumab-based therapy were enrolled from 20 hospitals across China. All patients were divided into two cohort: cohort 1 included patients unable surgery or radiotherapy (RT), who received first-line treatment of pembolizumab-based, and cohort 2 included patients eligible for surgery or RT, who received pembrolizumab-based treatment with or without local therapy. The primary endpoint was overall survival (OS), while secondary endpoints included time of pembrolizumab treatment (TOPT), immune-related adverse events (irAEs), and best overall response (BOR). With a median follow-up of 18.5 months, the mOS was not reached, with a 18mo-OS rate was 55.8%. The mOS for cohort 1 was 21.2 months. Interestingly, mOS for cohort 2 was not reached. Patients who received local therapy had a significantly improvement on 18mo-OS rate compared to those who did not (86.1% vs. 65.8%, p=0.021). A total of 24.7% of patients experienced irAEs. The study was the first report that the patient who was eligible for local treatment had a benefit from pembrolizumab, especially the OS was significantly improved for pembrolizumab followed by surgery or RT.Copyright © 2025. Published by Elsevier B.V.

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大类 | 1 区 医学
小类 | 2 区 肿瘤学
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大类 | 1 区 医学
小类 | 2 区 肿瘤学
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Q1 ONCOLOGY
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第一作者机构: [1]Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong 250117, P.R. China.
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