机构：[1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Dept Med Oncol, Natl Canc Ctr,Natl Clin Res Ctr Canc, Beijing, Peoples R China[2]Xinxiang Med Univ, Dept Med Oncol, Affiliated Hosp 1, Xinxiang, Peoples R China[3]Xingtai Peoples Hosp, Dept Thorac Surg, Xingtai, Peoples R China[4]Shandong First Med Univ, Canc Hosp, Shandong Canc Hosp, Dept Gastrointestinal Oncol, Jinan, Peoples R China[5]Shandong First Med Univ, Dept Med Oncol, Cent Hosp, Jinan, Peoples R China[6]Sichuan Canc Hosp, Dept Med Oncol, Chengdu, Peoples R China四川省肿瘤医院[7]Fudan Univ, Shanghai Canc Ctr, Dept Radiat Oncol, Shanghai, Peoples R China[8]Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Dept Integrated Tradit & Western Med, Shanghai, Peoples R China[9]Zunyi Med Univ, Affiliated Hosp, Dept Thorac Surg, Zunyi, Peoples R China[10]Anhui Prov Canc Hosp, Dept Med Oncol, Hefei, Peoples R China[11]Xuzhou Cent Hosp, Dept Med Oncol, Xuzhou, Peoples R China[12]Fujian Canc Hosp, Dept Med Oncol, Fuzhou, Peoples R China[13]Canc Hosp China Med Univ, Liaoning Canc Hosp & Inst, Med Oncol Dept Gastrointestinal Canc, Shenyang, Peoples R China[14]Chongqing Univ, Three Gorges Hosp, Dept Oncol, Chongqing, Peoples R China[15]First Affiliated Hosp, Bengbu Med Coll, Dept Radiat Oncol, Bengbu, Peoples R China[16]Anhui Med Univ, Dept Med Oncol, Affiliated Hosp 1, Hefei, Peoples R China[17]Xiamen Univ, Affiliated Hosp 1, Dept Med Oncol, Xiamen, Peoples R China[18]Shanghai Henlius Biotech Inc, Shanghai, Peoples R China
First-line systemic therapeutic options for advanced esophageal squamous cell carcinoma (ESCC) are limited. In this multicenter, double-blind phase 3 trial, a total of 551 patients with previously untreated, locally advanced or metastatic ESCC and PD-L1 combined positive score of >= 1 were randomized (2:1) to receive serplulimab (an anti-PD-1 antibody; 3 mg/kg) or placebo (on day 1), plus cisplatin (50 mg/m(2)) (on day 1) and continuous infusion of 5-fluorouracil (1,200 mg/m(2)) (on days 1 and 2), once every 2 weeks. The study met the primary endpoints. At the prespecified final analysis of progression-free survival (PFS) assessed by the blinded independent radiological review committee, serplulimab plus chemotherapy significantly improved PFS compared with placebo plus chemotherapy (median PFS of 5.8 months and 5.3 months, respectively; hazard ratio, 0.60; 95% confidence interval, 0.48-0.75; P < 0.0001). At the prespecified interim analysis of overall survival (OS), serplulimab plus chemotherapy also significantly prolonged OS compared with placebo plus chemotherapy (median OS of 15.3 months and 11.8 months, respectively; hazard ratio, 0.68; 95% confidence interval, 0.53-0.87; P = 0.0020). Grade 3 or higher treatment-related adverse events occurred in 201 (53%) and 81 (48%) patients in the serplulimab plus chemotherapy group and the placebo plus chemotherapy group, respectively. Serplulimab plus chemotherapy administered every 2 weeks significantly improved PFS and OS in patients with previously untreated, PD-L1-positive advanced ESCC, with a manageable safety profile. This study is registered with ClinicalTrials.gov (NCT03958890).
基金：
Shanghai Henlius Biotech, Inc.
语种：
外文
高被引：
被引次数：
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PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类|1 区医学
小类|1 区生化与分子生物学1 区细胞生物学1 区医学：研究与实验
最新[2023]版：
大类|1 区医学
小类|1 区生化与分子生物学1 区细胞生物学1 区医学：研究与实验
JCR分区：
出版当年[2023]版：
Q1BIOCHEMISTRY & MOLECULAR BIOLOGYQ1CELL BIOLOGYQ1MEDICINE, RESEARCH & EXPERIMENTAL
最新[2023]版：
Q1BIOCHEMISTRY & MOLECULAR BIOLOGYQ1CELL BIOLOGYQ1MEDICINE, RESEARCH & EXPERIMENTAL
第一作者机构：[1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Dept Med Oncol, Natl Canc Ctr,Natl Clin Res Ctr Canc, Beijing, Peoples R China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Song Yan,Zhang Bo,Xin Dao,et al.First-line serplulimab or placebo plus chemotherapy in PD-L1-positive esophageal squamous cell carcinoma: a randomized, double-blind phase 3 trial[J].NATURE MEDICINE.2023,29(2):doi:10.1038/s41591-022-02179-2.
APA：
Song, Yan,Zhang, Bo,Xin, Dao,Kou, Xiaoge,Tan, Zhenbo...&Huang, Jing.(2023).First-line serplulimab or placebo plus chemotherapy in PD-L1-positive esophageal squamous cell carcinoma: a randomized, double-blind phase 3 trial.NATURE MEDICINE,29,(2)
MLA：
Song, Yan,et al."First-line serplulimab or placebo plus chemotherapy in PD-L1-positive esophageal squamous cell carcinoma: a randomized, double-blind phase 3 trial".NATURE MEDICINE 29..2(2023)
医学