替雷利珠单抗联合化疗用于初治的晚期食管鳞状细胞癌（JUPITER-06）：一项多中心3期试验
Toripalimab plus chemotherapy in treatment-naïve, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial.
作者信息
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, Qin Yanru, Shi Zhihong, Wei Qichun, Xiao Ke, Zhang Yan, Zhang Ying, Chen Xin, Dai Guanghai, He Jianxing, Li Junhe, Li Guanghui, Liu Yong, Liu Zhihua, Yuan Xianglin, Zhang Junping, Fu Zhichao, He Yifu, Ju Fang, Liu Zheng, Tang Peng, Wang Tiejun, Wang Weibo, Zhang Jing, Luo Xianming, Tang Xiongwen, May Rena, Feng Hui, Yao Sheng, Keegan Patricia, Xu Rui-Hua, Wang Feng
机构信息
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 Medical Sciences, Guangzhou 510060, China.
Cancer Hospital Chinese Academy of Medical Sciences, Beijing 100021, China.
出版信息
Cancer Cell. 2022 Mar 14;40(3):277-288.e3. doi: 10.1016/j.ccell.2022.02.007. Epub 2022 Mar 3.
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 (1:1) 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.
铂类化疗是晚期食管鳞状细胞癌（ESCC）的标准一线治疗方案。在这项3期研究（ClinicalTrial.gov：NCT03829969）中，514例未经治疗的晚期ESCC患者被随机（1:1）分为两组，分别接受托瑞帕利单抗或安慰剂联合紫杉醇加顺铂（TP）治疗，每3周一次，共6个周期，随后接受托瑞帕利单抗或安慰剂维持治疗。在预先设定的无进展生存期（PFS）最终分析中，托瑞帕利单抗组的PFS较安慰剂组有显著改善（风险比[HR]=0.58；95%置信区间，0.46 - 0.74；p<0.0001）。预先设定的总生存期（OS）中期分析也显示，接受托瑞帕利单抗加TP治疗的患者较接受安慰剂加TP治疗的患者OS有显著改善（HR=0.58；95%置信区间，0.43 - 0.78；p=0.0004）。两组≥3级治疗中出现的不良事件发生率相似。托瑞帕利单抗加TP可显著改善未经治疗的晚期ESCC患者的PFS和OS，且安全性可控。
Zotero 插件