| Literature DB >> 35245446 |
Zi-Xian Wang1, Chengxu Cui2, Jun Yao3, Yanqiao Zhang4, Mengxia Li5, Jifeng Feng6, Shujun Yang7, Yun Fan8, Jianhua Shi9, Xizhi Zhang10, Lin Shen11, Yongqian Shu12, Cailian Wang13, Tianyang Dai14, Teng Mao15, Long Chen16, Zengqing Guo17, Bo Liu18, Hongming Pan19, Shundong Cang20, Yi Jiang21, Junye Wang22, Min Ye23, Zhendong Chen24, Da Jiang25, Qin Lin26, Wei Ren27, Junsheng Wang28, Lin Wu29, Yong Xu30, Zhanhui Miao31, Meili Sun32, Conghua Xie33, Ying Liu34, Qifeng Wang35, Lina Zhao36, Qi Li37, Canhong Huang38, Ke Jiang39, Kunyu Yang39, Daojun Li40, Yunpeng Liu41, Zhitu Zhu42, Rixin Chen43, Liqun Jia44, Wei Li45, Wangjun Liao46, Hong-Xu Liu47, Daiyuan Ma48, Jie Ma49, Yanru Qin50, Zhihong Shi51, Qichun Wei52, Ke Xiao53, Yan Zhang54, Ying Zhang55, Xin Chen56, Guanghai Dai57, Jianxing He58, Junhe Li59, Guanghui Li60, Yong Liu61, Zhihua Liu62, Xianglin Yuan63, Junping Zhang64, Zhichao Fu65, Yifu He66, Fang Ju67, Zheng Liu68, Peng Tang69, Tiejun Wang70, Weibo Wang71, Jing Zhang72, Xianming Luo73, Xiongwen Tang74, Rena May75, Hui Feng74, Sheng Yao74, Patricia Keegan75, Rui-Hua Xu76, Feng Wang77.
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 (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.Entities:
Keywords: PD-1 inhibitor; advanced esophageal squamous cell carcinoma; double-blind; immunotherapy; multi-center; paclitaxel plus cisplatin; randomized study
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Year: 2022 PMID： 35245446 DOI： 10.1016/j.ccell.2022.02.007
Source DB: PubMed Journal: Cancer Cell ISSN： 1535-6108 Impact factor: 31.743