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Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial.
Wang, Zi-Xian; Cui, Chengxu; Yao, Jun; Zhang, Yanqiao; Li, Mengxia; Feng, Jifeng; Yang, Shujun; Fan, Yun; Shi, Jianhua; Zhang, Xizhi; Shen, Lin; Shu, Yongqian; Wang, Cailian; Dai, Tianyang; Mao, Teng; Chen, Long; Guo, Zengqing; Liu, Bo; Pan, Hongming; Cang, Shundong; Jiang, Yi; Wang, Junye; Ye, Min; Chen, Zhendong; Jiang, Da; Lin, Qin; Ren, Wei; Wang, Junsheng; Wu, Lin; Xu, Yong; Miao, Zhanhui; Sun, Meili; Xie, Conghua; Liu, Ying; Wang, Qifeng; Zhao, Lina; Li, Qi; Huang, Canhong; Jiang, Ke; Yang, Kunyu; Li, Daojun; Liu, Yunpeng; Zhu, Zhitu; Chen, Rixin; Jia, Liqun; Li, Wei; Liao, Wangjun; Liu, Hong-Xu; Ma, Daiyuan; Ma, Jie.
Affiliation
  • Wang ZX; Department of Medical Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center of Cancer Medicine, Guangzhou 510060, China; Research Unit of Precision Diagnosis and Treatment for Gastrointestinal Cancer, Chinese Academy of Medic
  • Cui C; Cancer Hospital Chinese Academy of Medical Sciences, Beijing 100021, China.
  • Yao J; The First Affiliated Hospital of Henan University of Science and Technology, Luoyang 471000, China.
  • Zhang Y; Harbin Medical University Cancer Hospital, Harbin 150081, China.
  • Li M; Army Medical Center of PLA, Chongqing 400042, China.
  • Feng J; Jiangsu Cancer Hospital, Nanjing 210009, China.
  • Yang S; Henan Cancer Hospital & Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.
  • Fan Y; Zhejiang Cancer Hospital, Hangzhou 310022, China.
  • Shi J; Linyi Cancer Hospital, Linyi 276000, China.
  • Zhang X; The Northern Jiangsu People's Hospital, Yangzhou 225001, China.
  • Shen L; Beijing Cancer Hospital, Beijing 100142, China.
  • Shu Y; Jiangsu Province Hospital, Nanjing 210029, China.
  • Wang C; Zhongda Hospital Southeast University, Nanjing 210009, China.
  • Dai T; The Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.
  • Mao T; Shanghai Chest Hospital, Shanghai 200030, China.
  • Chen L; Guangxi Medical University Affiliated Tumor Hospital, Nanning 530000, China.
  • Guo Z; Fujian Cancer Hospital, Fuzhou 350000, China.
  • Liu B; Shandong Cancer Hospital, Jinan 250117, China.
  • Pan H; Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou 310000, China.
  • Cang S; Henan Provincial People's Hospital, Zhengzhou 450000, China.
  • Jiang Y; The Affiliated Cancer Hospital of Shantou University Medical College, Shantou 515000, China.
  • Wang J; Affiliated Hospital of Jining Medical University, Jining 272000, China.
  • Ye M; Jiangmen Central Hospital, Jiangmen 529000, China.
  • Chen Z; The Second Hospital of Anhui Medical University, Hefei 230000, China.
  • Jiang D; The Fourth Hospital of Hebei Medical University, Shijiazhuang 050000, China.
  • Lin Q; The First Affiliated Hospital of Xiamen University, Xiamen 361000, China.
  • Ren W; Nanjing Drum Tower Hospital, Nanjing 530000, China.
  • Wang J; Anyang Cancer Hospital, Anyang 455000, China.
  • Wu L; Hunan Cancer Hospital, Changsha 410000, China.
  • Xu Y; West China Hospital of Sichuan University, Chengdu 610000, China.
  • Miao Z; The First Affiliated Hospital of Xinxiang Medical University, Weihui 453100, China.
  • Sun M; Jinan Central Hospital, Jinan 250000, China.
  • Xie C; Zhongnan Hospital of Wuhan University, Wuhan 430000, China.
  • Liu Y; Henan Cancer Hospital & Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450000, China.
  • Wang Q; Sichuan Cancer Hospital, Chengdu 610000, China.
  • Zhao L; Xijing Hospital, Xi'an 710000, China.
  • Li Q; Shanghai General Hospital, Shanghai 200000, China.
  • Huang C; Nantong Tumor Hospital, Nantong 226000, China.
  • Jiang K; Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430000, China.
  • Yang K; Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan 430000, China.
  • Li D; Yichang Central People's Hospital, Yichang 443000, China.
  • Liu Y; The First Hospital of China Medical University, Shenyang 110000, China.
  • Zhu Z; The First Affiliated Hospital of Jinzhou Medical University, Jinzhou 121000, China.
  • Chen R; Liuzhou People's Hospital, Liuzhou 545000, China.
  • Jia L; China-Japan Friendship Hospital, Beijing 100000, China.
  • Li W; The First Bethune Hospital of Jilin University, Changchun 130000, China.
  • Liao W; Nanfang Hospital Southern Medical University, Guangzhou 510000, China.
  • Liu HX; Liaoning Cancer Hospital & Institute, Shenyang 110000, China.
  • Ma D; The Affiliated Hospital of North Sichuan Medical College, Nanchong 637000, China.
  • Ma J; The First Affiliated Hospital of Guangxi Medical University, Nanning 530000, China.
Cancer Cell ; 40(3): 277-288.e3, 2022 03 14.
Article in En | MEDLINE | ID: mdl-35245446
ABSTRACT
Platinum-based chemotherapy is the standard first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). In this phase 3 study (ClinicalTrial.gov NCT03829969), 514 patients with treatment-naïve advanced ESCC were randomized (11) to receive toripalimab or placebo in combination with paclitaxel plus cisplatin (TP) every 3 weeks for up to 6 cycles, followed by toripalimab or placebo maintenance. At the prespecified final analysis of progression-free survival (PFS), a significant improvement in PFS is observed for the toripalimab arm over the placebo arm (hazard ratio [HR] = 0.58; 95% CI, 0.46-0.74; p < 0.0001). The prespecified interim analysis of overall survival (OS) also reveals a significant OS improvement for patients treated with toripalimab plus TP over placebo plus TP (HR = 0.58; 95% CI, 0.43-0.78; p = 0.0004). The incidences of grade ≥3 treatment-emergent adverse events are similar between the two arms. Toripalimab plus TP significantly improves PFS and OS in patients with treatment-naïve, advanced ESCC, with a manageable safety profile.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Esophageal Neoplasms / Esophageal Squamous Cell Carcinoma Type of study: Clinical_trials Limits: Humans Language: En Journal: Cancer Cell Year: 2022 Document type: Article
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Esophageal Neoplasms / Esophageal Squamous Cell Carcinoma Type of study: Clinical_trials Limits: Humans Language: En Journal: Cancer Cell Year: 2022 Document type: Article