单位：[1]Sun Yat Sen Univ, State Key Lab Oncol South China, Collaborat Innovat Ctr Canc Med, Dept Nasopharyngeal Carcinoma, Guangzhou, Peoples R China[2]Inst Guangzhou Med Univ, Affiliated Canc Hosp, Guangzhou, Peoples R China[3]Fudan Univ, Ctr Canc, Shanghai, Peoples R China[4]Huazhong Univ Sci & Technol, Union Hosp, Tongji Med Coll, Wuhan, Peoples R China华中科技大学同济医学院附属协和医院[5]Guangdong Med Univ, Affiliated Hosp, Zhanjiang, Peoples R China[6]Jiangxi Canc Hosp, Nanchang, Jiangxi, Peoples R China[7]Hunan Canc Hosp, Affiliated Canc Hosp, Xiangya Sch Med, Changsha, Peoples R China[8]Guizhou Med Univ, Guizhou Canc Hosp, Guiyang, Peoples R China[9]Shenzhen Peoples Hosp, Shenzhen, Peoples R China深圳市人民医院深圳医学信息中心[10]Fujian Prov Canc Hosp, Fuzhou, Peoples R China[11]Peoples Hosp Guangxi Zhuang Autonomous Reg, Nanning, Peoples R China[12]Sichuan Univ, West China Hosp, Chengdu, Peoples R China四川大学华西医院[13]Cent South Univ, Xiangya Hosp 2, Changsha, Peoples R China[14]Taichung Vet Gen Hosp, Taichung, Taiwan[15]Shantou Univ, Coll Med, Canc Hosp, Shantou, Peoples R China[16]Jiangsu Canc Hosp, Nanjing, Peoples R China[17]Chang Gung Mem Hosp, Taoyuan, Taiwan[18]Natl Canc Ctr, Singapore, Singapore[19]Nanfang Hosp, Guangzhou, Peoples R China[20]Chinese Acad Med Sci, Peking Union Med Coll, Canc Hosp, Beijing, Peoples R China[21]Zhejiang Canc Hosp, Hangzhou, Peoples R China浙江省肿瘤医院[22]Sun Yat Sen Univ, Affiliated Hosp 1, Zhuhai, Peoples R China中山大学附属第一医院[23]Huazhong Univ Sci & Technol, Tongji Med Coll, Tongji Hosp, Wuhan, Peoples R China华中科技大学同济医学院附属同济医院[24]Shanghai Gen Hosp, Shanghai, Peoples R China[25]Fujian Med Univ, Union Hosp, Fuzhou, Peoples R China[26]Hebei Med Univ, Hebei Canc Hosp, Hosp 4, Shijiazhuang, Hebei, Peoples R China河北医科大学第四医院[27]Hainan Gen Hosp, Haikou, Hainan, Peoples R China[28]Liuzhou Workers Hosp, Liuzhou, Peoples R China[29]China Med Univ Hosp, Taichung, Taiwan[30]Taipei Vet Gen Hosp, Taipei, Taiwan[31]Natl Cheng Kung Univ, Tainan, Taiwan[32]Tan Tock Seng Hosp, Singapore, Singapore[33]Johns Hopkins Univ, Baltimore, MD USA[34]Shanghai Junshi Biosci, Shanghai, Peoples R China[35]Top Alliance Biosci, Rockville, MD USA[36]Sun Yat Sen Univ, Dept Med Oncol, State Key Lab Oncol South China, Collaborat Innovat Ctr Canc Med, Guangzhou, Peoples R 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
语种：
外文
高被引：
被引次数：
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PubmedID：
中科院(CAS)分区：
出版当年[2020]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[2025]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[2019]版：
Q1MEDICINE, RESEARCH & EXPERIMENTALQ1CELL BIOLOGYQ1BIOCHEMISTRY & MOLECULAR BIOLOGY
最新[2023]版：
Q1BIOCHEMISTRY & MOLECULAR BIOLOGYQ1CELL BIOLOGYQ1MEDICINE, RESEARCH & EXPERIMENTAL
第一作者单位：[1]Sun Yat Sen Univ, State Key Lab Oncol South China, Collaborat Innovat Ctr Canc Med, Dept Nasopharyngeal Carcinoma, Guangzhou, Peoples R China
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