机构：[1]Department of Nasopharyngeal Carcinoma, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, CollaborativeInnovation Center of Cancer Medicine, Guangzhou, China[2]Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangzhou, China[3]Fudan University Cancer Center, Shanghai, China[4]Union Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan,China华中科技大学同济医学院附属协和医院[5]Affiliated Hospital of Guangdong Medical University, Zhanjiang, China[6]Jiangxi Cancer Hospital, Nanchang, China[7]Hunan Cancer Hospitaland the Affiliated Cancer Hospital of Xiangya School of Medicine, Changsha, China[8]Guizhou Cancer Hospital of Guizhou Medical University, Guiyang,China[9]Shenzhen People’s Hospital, Shenzhen, China深圳市人民医院深圳医学信息中心[10]Fujian Provincial Cancer Hospital, Fuzhou, China[11]The People’s Hospital of Guangxi ZhuangAutonomous Region, Nanning, China[12]West China Hospital of Sichuan University, Chengdu, China四川大学华西医院[13]The Second Xiangya Hospital of Central SouthUniversity, Changsha, China[14]Taichung Veterans General Hospital, Taichung, Taiwan[15]Cancer Hospital of Shantou University Medical College, Shantou,China[16]Jiangsu Cancer Hospital, Nanjing, China[17]Chang Gung Memorial Hospital, Taoyuan, Taiwan中山大学附属第二医院[18]National Cancer Centre, Singapore City, Singapore[19]Nanfang Hospital, Guangzhou, China[20]Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China[21]Zhejiang Cancer Hospital, Hangzhou, China浙江省肿瘤医院[22]The Fifth Affiliated Hospital of Sun Yat-Sen University, Zhuhai, China[23]Tongji Hospital, Tongji MedicalCollege, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属同济医院[24]Shanghai General Hospital, Shanghai, China[25]Fujian Medical University UnionHospital, Fuzhou, China[26]The Fourth Hospital of Hebei Medical University Hebei Cancer Hospital, Shijiazhuang, China河北医科大学第四医院[27]Hainan General Hospital, Haikou,China[28]Liuzhou Worker’s Hospital, Liuzhou, China[29]China Medical University Hospital, Taichung, Taiwan[30]Taipei Veterans General Hospital, Taipei,Taiwan[31]National Cheng Kung University, Tainan, Taiwan[32]Tan Tock Seng Hospital, Singapore City, Singapore[33]Johns Hopkins University, Baltimore, MD,USA[34]Shanghai Junshi Biosciences, Shanghai, China[35]TopAlliance Biosciences, Rockville, MD, USA[36]Department of Medical Oncology, Sun Yat-SenUniversity Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou, China
Gemcitabine-cisplatin (GP) chemotherapy is the standard first-line systemic treatment for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). In this international, double-blind, phase 3 trial (ClinicalTrials.gov identifier: NCT03581786), 289 patients with RM-NPC and no previous chemotherapy for recurrent or metastatic disease were randomized (1/1) to receive either toripalimab, a monoclonal antibody against human programmed death-1 (PD-1), or placebo in combination with GP every 3 weeks for up to six cycles, followed by monotherapy with toripalimab or placebo. The primary endpoint was progression-free survival (PFS) as assessed by a blinded independent review committee according to RECIST v.1.1. At the prespecified interim PFS analysis, a significant improvement in PFS was detected in the toripalimab arm compared to the placebo arm: median PFS of 11.7 versus 8.0 months, hazard ratio (HR) = 0.52 (95% confidence interval (CI): 0.36-0.74), P = 0.0003. An improvement in PFS was observed across key subgroups, including PD-L1 expression. As of 18 February 2021, a 40% reduction in risk of death was observed in the toripalimab arm compared to the placebo arm (HR = 0.603 (95% CI: 0.364-0.997)). The incidence of grade >= 3 adverse events (AEs) (89.0 versus 89.5%), AEs leading to discontinuation of toripalimab/placebo (7.5 versus 4.9%) and fatal AEs (2.7 versus 2.8%) was similar between the two arms; however, immune-related AEs (39.7 versus 18.9%) and grade >= 3 infusion reactions (7.5 versus 0.7%) were more frequent in the toripalimab arm. In conclusion, the addition of toripalimab to GP chemotherapy as a first-line treatment for patients with RM-NPC provided superior PFS compared to GP alone, and with a manageable safety profile. Interim analysis from the randomized phase 3 JUPITER-02 trial shows that the addition of anti-PD-1 toripalimab to standard gemcitabine/cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma has manageable toxicity and improves progression-free survival, suggesting a potential new treatment standard in this setting.
基金：
National Major Science & Technology Major Projects [2017ZX09302009]; Shanghai Science and Technology Committee Technology Grant [17431900700]; Shanghai Junshi Biosciences
基金编号：2017ZX0930200917431900700
语种：
外文
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被引次数：
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PubmedID：
中科院(CAS)分区：
出版当年[2021]版：
大类|1 区医学
小类|1 区生化与分子生物学1 区细胞生物学1 区医学：研究与实验
最新[2023]版：
大类|1 区医学
小类|1 区生化与分子生物学1 区细胞生物学1 区医学：研究与实验
JCR分区：
出版当年[2021]版：
Q1BIOCHEMISTRY & MOLECULAR BIOLOGYQ1CELL BIOLOGYQ1MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版：
Q1BIOCHEMISTRY & MOLECULAR BIOLOGYQ1CELL BIOLOGYQ1MEDICINE, RESEARCH & EXPERIMENTAL
第一作者机构：[1]Department of Nasopharyngeal Carcinoma, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, CollaborativeInnovation Center of Cancer Medicine, Guangzhou, China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Mai Hai-Qiang,Chen Qiu-Yan,Chen Dongping,et al.Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial[J].NATURE MEDICINE.2021,27(9):1536-+.doi:10.1038/s41591-021-01444-0.
APA：
Mai, Hai-Qiang,Chen, Qiu-Yan,Chen, Dongping,Hu, Chaosu,Yang, Kunyu...&Xu, Rui-Hua.(2021).Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial.NATURE MEDICINE,27,(9)
MLA：
Mai, Hai-Qiang,et al."Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial".NATURE MEDICINE 27..9(2021):1536-+
医学