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-naive 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 pre specified 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 pre specified 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 R3 treatment-emergent adverse events are similar between the two arms. Toripalimab plus TP significantly improves PFS and OS in patients with treatment-naive, advanced ESCC, with a manageable safety profile.
基金:
Guangdong Esophageal Cancer Institute Science and Technology Program [M201905]; National Natural Sci-ence Foundation of China [81872011, 82061160373]; Science and Technology Program of Guangdong [2019B020227002]; CAMS Innovation Fund for Medical Sciences [2019-I2M-5-036]; National Major Science AMP; Technology Major Projects [2017ZX09302009]; Shanghai Science and Technology Committee Technology Grant [17431900700]
第一作者单位:[1]Sun Yat Sen Univ, State Key Lab Oncol South China, Collaborat Innovat Ctr Canc Med, Dept Med Oncol,Canc Ctr, Guangzhou 510060, Peoples R China[2]Chinese Acad Med Sci, Res Unit Precis Diag & Treatment Gastrointestinal, Guangzhou 510060, Peoples R China
通讯作者:
通讯机构:[1]Sun Yat Sen Univ, State Key Lab Oncol South China, Collaborat Innovat Ctr Canc Med, Dept Med Oncol,Canc Ctr, Guangzhou 510060, Peoples R China[2]Chinese Acad Med Sci, Res Unit Precis Diag & Treatment Gastrointestinal, Guangzhou 510060, Peoples R China
推荐引用方式(GB/T 7714):
Wang Zi-Xian,Cui Chengxu,Yao Jun,et al.Toripalimab plus chemotherapy in treatment-naive, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial[J].CANCER CELL.2022,40(3):277-+.doi:10.1016/j.ccell.2022.02.007.
APA:
Wang, Zi-Xian,Cui, Chengxu,Yao, Jun,Zhang, Yanqiao,Li, Mengxia...&Wang, Feng.(2022).Toripalimab plus chemotherapy in treatment-naive, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial.CANCER CELL,40,(3)
MLA:
Wang, Zi-Xian,et al."Toripalimab plus chemotherapy in treatment-naive, advanced esophageal squamous cell carcinoma (JUPITER-06): A multi-center phase 3 trial".CANCER CELL 40..3(2022):277-+