First-line benmelstobart plus anlotinib and chemotherapy in advanced or metastatic/recurrent esophageal squamous cell carcinoma:a multi-center phase 2 study  

作　　者：Ning Li Jin Xia Xiaohui Gao Jianwei Zhou Yonggui Hong Donghai Cui Xuesong Zhao Tao Wu Yanzhen Guo Junsheng Wang Suxia Luo 

机构地区：[1]Department of Gastrointestinal Oncology,The Affiliated Cancer Hospital of Zhengzhou University&Henan Cancer Hospital,Zhengzhou,China [2]Department of Medical Oncology,Anyang Tumor Hospital&The Affiliated Anyang Tumor Hospital of Henan University of Science and Technology,Anyang,Henan,China [3]Department of Respiratory Oncology,The First Affiliated Hospital of Henan University of Science and Technology,Luoyang,Henan,China [4]Department of Oncology,Henan Provincial People’s Hospital,Zhengzhou,Henan,China [5]Department of Tumor Radiotherapy,The People’s Hospital of Anyang City,Anyang,Henan,China

出　　处：《Signal Transduction and Targeted Therapy》2024年第12期5664-5670,共7页信号转导与靶向治疗(英文)

基　　金：Henan Province Health Science and Technology Innovation Young and Middle-Aged Leader Project(YXKC2021008).

摘　　要：Although first-line immunochemotherapy has improved prognosis for patients with advanced esophageal squamous cell carcinoma(ESCC),more effective strategies still require further investigation.This multi-center,phase II study(ClinicalTrials.gov NCT05013697)assessed the feasibility of benmelstobart(a novel PD-L1 inhibitor)plus anlotinib(multitargeted TKI)and chemotherapy in advanced or metastatic/recurrent ESCC.Eligible patients received 4-6 cycles(21-day)of benmelstobart(1200 mg),anlotinib(10 mg)plus paclitaxel(135 mg/m^(2))/cisplatin(60-75 mg/m^(2)),then maintained with benmelstobart and anlotinib.Primary endpoint was progression-free survival(PFS)assessed according to RECIST v1.1.Secondary endpoints were tumor response,overall survival(OS),and safety assessed by adverse events(AEs).From September 2021 to November 2023,50 patients were enrolled and received study treatment.With median follow-up of 23.7 months as of April 1,2024,median PFS was 14.9 months(95%CI,11.4-not estimable[NE])and the 1-year PFS was 58.5%(95%CI,41.9%-71.9%).Among 50 patients,confirmed objective response rate was 72.0%and disease control rate was 84.0%.Median duration of response of 36 responders was 16.2 months(95%CI,10.2-NE).At the cutoff date,31 patients remained alive;median OS was not reached(95%CI,13.2 months-NE)with 1-year OS of 74.8%(95%CI,59.8%-84.8%).Forty-six(92.0%)patients reported treatment-related AEs,with 37(74.0%)were grade≥3.Overall,benmelstobart plus anlotinib and chemotherapy showed promising efficacy and acceptable toxicity in advanced or metastatic/recurrent ESCC.

关 键 词：ESOPHAGEAL CHEMOTHERAPY METASTATIC 

分 类 号：R735.1[医药卫生—肿瘤]