小柯机器人

中山大学肿瘤防治中心王峰、徐瑞华等研究人员合作完成特瑞普利单抗联合化疗对比化疗一线治疗晚期食管鳞癌的临床试验。相关论文于2022年3月3日在线发表于国际学术期刊《癌细胞》。

研究人员表示，铂化疗是晚期食管鳞状细胞癌（ESCC）的标准一线治疗。

在这项3期研究中（ClinicalTrial.gov: NCT03829969），514名治疗无效的晚期ESCC患者被随机（1:1）接受特瑞普利单抗或安慰剂联合紫杉醇加顺铂（TP）每3周一次，最多6个周期，随后接受特瑞普利单抗或安慰剂维持治疗。在对无进展生存期（PFS）的预先指定的最终分析中，观察到特瑞普利单抗组比安慰剂组的PFS有明显改善（风险比[HR]=0.58；95%CI，0.46-0.74；P＜0.0001）。

预先指定的总生存期（OS）中期分析也显示，用特瑞普利单抗加TP治疗的患者比用安慰剂加TP治疗的患者有明显的OS改善（HR=0.58；95%CI，0.43-0.78；p=0.0004）。两组之间≥3级的治疗性不良事件的发生率相似。特瑞普利单抗加TP可显著改善治疗无效的晚期ESCC患者的PFS和OS，且安全状况可控。

附：英文原文

Title: Toripalimab plus chemotherapy in treatment-nave, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial

Author: Zi-Xian Wang, Chengxu Cui, Jun Yao, Yanqiao Zhang, Mengxia Li, Jifeng Feng, Shujun Yang, Yun Fan, Jianhua Shi, Xizhi Zhang, Lin Shen, Yongqian Shu, Cailian Wang, Tianyang Dai, Teng Mao, Long Chen, Zengqing Guo, Bo Liu, Hongming Pan, Shundong Cang, Yi Jiang, Junye Wang, Min Ye, Zhendong Chen, Da Jiang, Qin Lin, Wei Ren, Junsheng Wang, Lin Wu, Yong Xu, Zhanhui Miao, Meili Sun, Conghua Xie, Ying Liu, Qifeng Wang, Lina Zhao, Qi Li, Canhong Huang, Ke Jiang, Kunyu Yang, Daojun Li, Yunpeng Liu, Zhitu Zhu, Rixin Chen, Liqun Jia, Wei Li, Wangjun Liao, Hong-Xu Liu, Daiyuan Ma, Jie Ma, Yanru Qin, Zhihong Shi, Qichun Wei, Ke Xiao, Yan Zhang, Ying Zhang, Xin Chen, Guanghai Dai, Jianxing He, Junhe Li, Guanghui Li, Yong Liu, Zhihua Liu, Xianglin Yuan, Junping Zhang, Zhichao Fu, Yifu He, Fang Ju, Zheng Liu, Peng Tang, Tiejun Wang, Weibo Wang, Jing Zhang, Xianming Luo, Xiongwen Tang

Issue&Volume: 2022-03-03

Abstract: Platinum-based chemotherapy is the standard first-line treatment for advanced esophagealsquamous cell carcinoma (ESCC). In this phase 3 study (ClinicalTrial.gov: NCT03829969),514 patients with treatment-nave advanced ESCC were randomized (1:1) to receive toripalimabor placebo in combination with paclitaxel plus cisplatin (TP) every 3 weeks for upto 6 cycles, followed by toripalimab or placebo maintenance. At the prespecified finalanalysis of progression-free survival (PFS), a significant improvement in PFS is observedfor 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 revealsa significant OS improvement for patients treated with toripalimab plus TP over placeboplus TP (HR = 0.58; 95% CI, 0.43–0.78; p = 0.0004). The incidences of grade ≥3 treatment-emergentadverse events are similar between the two arms. Toripalimab plus TP significantlyimproves PFS and OS in patients with treatment-nave, advanced ESCC, with a manageablesafety profile.

DOI: 10.1016/j.ccell.2022.02.007

Source: https://www.cell.com/cancer-cell/fulltext/S1535-6108(22)00059-9

Cancer Cell：《癌细胞》，创刊于2002年。隶属于细胞出版社，最新IF：38.585
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