{"title":"帕姆单抗一线联合或不联合化疗治疗复发性或转移性头颈部鳞状细胞癌：KEYNOTE-048日本人群的5年随访。","authors":"Nobuhiko Oridate, Shunji Takahashi, Kaoru Tanaka, Yasushi Shimizu, Yasushi Fujimoto, Koji Matsumoto, Tomoya Yokota, Tomoko Yamazaki, Masanobu Takahashi, Tsutomu Ueda, Nobuhiro Hanai, Hironori Yamaguchi, Hiroki Hara, Tomokazu Yoshizaki, Ryuji Yasumatsu, Masahiro Nakayama, Kiyoto Shiga, Takashi Fujii, Kenji Mitsugi, Kenichi Takahashi, Nijiro Nohata, Burak Gumuscu, Nati Lerman, Makoto Tahara","doi":"10.1007/s10147-024-02632-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Previously reported results from phase III KEYNOTE-048 demonstrated similar or improved overall survival (OS) with pembrolizumab or pembrolizumab-chemotherapy versus cetuximab-chemotherapy (EXTREME) in Japanese patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). We report results in Japanese patients from KEYNOTE-048 after 5 years of follow-up.</p><p><strong>Methods: </strong>Patients with R/M HNSCC of the oropharynx, oral cavity, hypopharynx, or larynx were randomly assigned 1:1:1 to pembrolizumab, pembrolizumab-chemotherapy, or EXTREME. Primary endpoints were OS and progression-free survival. Efficacy was evaluated in the programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥ 20, PD-L1 CPS ≥ 1, and total Japanese populations.</p><p><strong>Results: </strong>In Japan, 67 patients were enrolled (pembrolizumab, n = 23; pembrolizumab-chemotherapy, n = 25; EXTREME, n = 19). Median follow-up was 71.0 months (range, 61.2-81.5); data cutoff, February 21, 2022. 5-year OS rates with pembrolizumab versus EXTREME were 35.7% versus 12.5% (hazard ratio [HR] 0.38; 95% CI 0.13-1.05), 23.8% versus 12.5% (HR 0.70; 95% CI 0.34-1.45), and 30.4% versus 10.5% (HR 0.54; 95% CI 0.27-1.07) in the PD-L1 CPS ≥ 20, CPS ≥ 1, and total Japanese populations, respectively. 5-year OS rates with pembrolizumab-chemotherapy versus EXTREME were 20.0% versus 14.3% (HR 0.79; 95% CI 0.27-2.33), 10.5% versus 14.3% (HR 1.18; 95% CI 0.56-2.48), and 8.0% versus 12.5% (HR 1.11; 95% CI 0.57-2.16) in the PD-L1 CPS ≥ 20, CPS ≥ 1, and total Japanese populations, respectively.</p><p><strong>Conclusion: </strong>After 5 years of follow-up, pembrolizumab and pembrolizumab-chemotherapy showed long-term clinical benefits; results further support these treatments as first-line options for Japanese patients with R/M HNSCC.</p><p><strong>Clinical trial registration: </strong>NCT02358031.</p>","PeriodicalId":13869,"journal":{"name":"International Journal of Clinical Oncology","volume":" ","pages":"1825-1839"},"PeriodicalIF":2.4000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11588814/pdf/","citationCount":"0","resultStr":"{\"title\":\"First-line pembrolizumab with or without chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up of the Japanese population of KEYNOTE‑048.\",\"authors\":\"Nobuhiko Oridate, Shunji Takahashi, Kaoru Tanaka, Yasushi Shimizu, Yasushi Fujimoto, Koji Matsumoto, Tomoya Yokota, Tomoko Yamazaki, Masanobu Takahashi, Tsutomu Ueda, Nobuhiro Hanai, Hironori Yamaguchi, Hiroki Hara, Tomokazu Yoshizaki, Ryuji Yasumatsu, Masahiro Nakayama, Kiyoto Shiga, Takashi Fujii, Kenji Mitsugi, Kenichi Takahashi, Nijiro Nohata, Burak Gumuscu, Nati Lerman, Makoto Tahara\",\"doi\":\"10.1007/s10147-024-02632-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Previously reported results from phase III KEYNOTE-048 demonstrated similar or improved overall survival (OS) with pembrolizumab or pembrolizumab-chemotherapy versus cetuximab-chemotherapy (EXTREME) in Japanese patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). We report results in Japanese patients from KEYNOTE-048 after 5 years of follow-up.</p><p><strong>Methods: </strong>Patients with R/M HNSCC of the oropharynx, oral cavity, hypopharynx, or larynx were randomly assigned 1:1:1 to pembrolizumab, pembrolizumab-chemotherapy, or EXTREME. Primary endpoints were OS and progression-free survival. Efficacy was evaluated in the programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥ 20, PD-L1 CPS ≥ 1, and total Japanese populations.</p><p><strong>Results: </strong>In Japan, 67 patients were enrolled (pembrolizumab, n = 23; pembrolizumab-chemotherapy, n = 25; EXTREME, n = 19). Median follow-up was 71.0 months (range, 61.2-81.5); data cutoff, February 21, 2022. 5-year OS rates with pembrolizumab versus EXTREME were 35.7% versus 12.5% (hazard ratio [HR] 0.38; 95% CI 0.13-1.05), 23.8% versus 12.5% (HR 0.70; 95% CI 0.34-1.45), and 30.4% versus 10.5% (HR 0.54; 95% CI 0.27-1.07) in the PD-L1 CPS ≥ 20, CPS ≥ 1, and total Japanese populations, respectively. 5-year OS rates with pembrolizumab-chemotherapy versus EXTREME were 20.0% versus 14.3% (HR 0.79; 95% CI 0.27-2.33), 10.5% versus 14.3% (HR 1.18; 95% CI 0.56-2.48), and 8.0% versus 12.5% (HR 1.11; 95% CI 0.57-2.16) in the PD-L1 CPS ≥ 20, CPS ≥ 1, and total Japanese populations, respectively.</p><p><strong>Conclusion: </strong>After 5 years of follow-up, pembrolizumab and pembrolizumab-chemotherapy showed long-term clinical benefits; results further support these treatments as first-line options for Japanese patients with R/M HNSCC.</p><p><strong>Clinical trial registration: </strong>NCT02358031.</p>\",\"PeriodicalId\":13869,\"journal\":{\"name\":\"International Journal of Clinical Oncology\",\"volume\":\" \",\"pages\":\"1825-1839\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11588814/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Clinical Oncology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1007/s10147-024-02632-x\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/10/9 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Clinical Oncology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1007/s10147-024-02632-x","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/10/9 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
背景：此前报道的III期KEYNOTE-048结果显示，在日本复发性/转移性头颈部鳞状细胞癌（R/M HNSCC）患者中，使用pembrolizumab或pembrolizumab-化疗与西妥昔单抗-化疗（EXTREME）的总生存期（OS）相似或有所提高。我们报告了 KEYNOTE-048 日本患者 5 年的随访结果：口咽、口腔、下咽或喉R/M HNSCC患者按1:1:1随机分配至pembrolizumab、pembrolizumab-化疗或EXTREME。主要终点为OS和无进展生存期。疗效在程序性细胞死亡配体1（PD-L1）联合阳性评分（CPS）≥20分、PD-L1 CPS≥1分和日本总人群中进行评估：日本共有67名患者入组（pembrolizumab，n = 23；pembrolizumab-化疗，n = 25；EXTREME，n = 19）。中位随访时间为 71.0 个月（61.2-81.5 个月）；数据截止日期为 2022 年 2 月 21 日。在PD-L1 CPS≥20、CPS≥1和全部日本人群中，pembrolizumab与EXTREME的5年OS率分别为35.7%对12.5%（危险比[HR]0.38；95% CI 0.13-1.05）、23.8%对12.5%（HR 0.70；95% CI 0.34-1.45）和30.4%对10.5%（HR 0.54；95% CI 0.27-1.07）。在PD-L1 CPS≥20、CPS≥1和全部日本人群中，pembrolizumab化疗与EXTREME的5年OS率分别为20.0%对14.3%（HR 0.79；95% CI 0.27-2.33）、10.5%对14.3%（HR 1.18；95% CI 0.56-2.48）和8.0%对12.5%（HR 1.11；95% CI 0.57-2.16）：经过5年的随访，pembrolizumab和pembrolizumab-化疗显示出长期临床疗效；结果进一步支持这些疗法成为日本R/M HNSCC患者的一线选择：临床试验注册：NCT02358031。
First-line pembrolizumab with or without chemotherapy for recurrent or metastatic head and neck squamous cell carcinoma: 5-year follow-up of the Japanese population of KEYNOTE‑048.
Background: Previously reported results from phase III KEYNOTE-048 demonstrated similar or improved overall survival (OS) with pembrolizumab or pembrolizumab-chemotherapy versus cetuximab-chemotherapy (EXTREME) in Japanese patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). We report results in Japanese patients from KEYNOTE-048 after 5 years of follow-up.
Methods: Patients with R/M HNSCC of the oropharynx, oral cavity, hypopharynx, or larynx were randomly assigned 1:1:1 to pembrolizumab, pembrolizumab-chemotherapy, or EXTREME. Primary endpoints were OS and progression-free survival. Efficacy was evaluated in the programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥ 20, PD-L1 CPS ≥ 1, and total Japanese populations.
Results: In Japan, 67 patients were enrolled (pembrolizumab, n = 23; pembrolizumab-chemotherapy, n = 25; EXTREME, n = 19). Median follow-up was 71.0 months (range, 61.2-81.5); data cutoff, February 21, 2022. 5-year OS rates with pembrolizumab versus EXTREME were 35.7% versus 12.5% (hazard ratio [HR] 0.38; 95% CI 0.13-1.05), 23.8% versus 12.5% (HR 0.70; 95% CI 0.34-1.45), and 30.4% versus 10.5% (HR 0.54; 95% CI 0.27-1.07) in the PD-L1 CPS ≥ 20, CPS ≥ 1, and total Japanese populations, respectively. 5-year OS rates with pembrolizumab-chemotherapy versus EXTREME were 20.0% versus 14.3% (HR 0.79; 95% CI 0.27-2.33), 10.5% versus 14.3% (HR 1.18; 95% CI 0.56-2.48), and 8.0% versus 12.5% (HR 1.11; 95% CI 0.57-2.16) in the PD-L1 CPS ≥ 20, CPS ≥ 1, and total Japanese populations, respectively.
Conclusion: After 5 years of follow-up, pembrolizumab and pembrolizumab-chemotherapy showed long-term clinical benefits; results further support these treatments as first-line options for Japanese patients with R/M HNSCC.
期刊介绍：
The International Journal of Clinical Oncology (IJCO) welcomes original research papers on all aspects of clinical oncology that report the results of novel and timely investigations. Reports on clinical trials are encouraged. Experimental studies will also be accepted if they have obvious relevance to clinical oncology. Membership in the Japan Society of Clinical Oncology is not a prerequisite for submission to the journal. Papers are received on the understanding that: their contents have not been published in whole or in part elsewhere; that they are subject to peer review by at least two referees and the Editors, and to editorial revision of the language and contents; and that the Editors are responsible for their acceptance, rejection, and order of publication.
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