机构地区：[1]Department of Thoracic Surgery,The Affiliated Cancer Hospital of Zhengzhou University,Henan Cancer Hospital,Zhengzhou,Henan,P.R.China [2]Department of Immunotherapy,The Affiliated Cancer Hospital of Zhengzhou University,Henan Cancer Hospital,Zhengzhou,Henan,P.R.China [3]Department of Endoscopy,The Affiliated Cancer Hospital of Zhengzhou University,Henan Cancer Hospital,Zhengzhou,Henan,P.R.China [4]Department of Pathology,The Affiliated Cancer Hospital of Zhengzhou University,Henan Cancer Hospital,Zhengzhou,Henan,P.R.China [5]Department of Radiology,The Affiliated Cancer Hospital of Zhengzhou University,Henan Cancer Hospital,Zhengzhou,Henan,P.R.China [6]Department of Biobank,The Affiliated Cancer Hospital of Zhengzhou University,Henan Cancer Hospital,Zhengzhou,Henan,P.R.China [7]Department of Strategic Development,The Affiliated Cancer Hospital of Zhengzhou University,Henan Cancer Hospital,Zhengzhou,Henan,P.R.China [8]Department of Statistics,LinkDoc Technology Co.,Ltd,Beijing,P.R.China [9]Department of Cancer Epidemiology,The Affiliated Cancer Hospital of Zhengzhou University,Henan Cancer Hospital,Zhengzhou,P.R.China
出 处：《Cancer Communications》2024年第10期1214-1227,共14页癌症通讯（英文）
基 金：Central Plains Young Top Talent,Grant/Award Number:2022;Henan Province Medical Science and Technology Key Projects Coconstructed by the Ministry of Health,Grant/Award Number:SBGJ202102059;Wu Jieping Medical Foundation,Grant/Award Number:320.6750.2020-15-1;Henan Province Health Science and Technology Innovation Outstanding Young Talent Training Project,Grant/Award Number:YXKC2021029;National Natural Science Foundation of China,Grant/Award Number:82002521。
摘 要：Background:In the era of immunotherapy,neoadjuvant immunochemotherapy(NAIC)for the treatment of locally advanced esophageal squamous cell carcinoma(ESCC)is used clinically but lacks of high-level clinical evidence.This study aimed to compare the safety and long-term efficacy of NAIC followed byminimally invasive esophagectomy(MIE)with those of neoadjuvant chemotherapy(NAC)followed by MIE.Methods:A prospective,single-center,open-label,randomized phase Ⅲ clinical trial was conducted at Henan Cancer Hospital,Zhengzhou,China.Patients were randomly assigned to receive either neoadjuvant toripalimab(240mg)plus paclitaxel(175 mg/m^(2))+cisplatin(75 mg/m^(2))(toripalimab group)or paclitaxel+cisplatin alone(chemotherapy group)every 3 weeks for 2 cycles.After surgery,the toripalimab group received toripalimab(240 mg every 3 weeks for up to 6 months).The primary endpoint was event-free survival(EFS).The pathological complete response(pCR)and overall survival(OS)were key secondary endpoints.Adverse events(AEs)and quality of life were also assessed.Results:Between May 15,2020 and August 13,2021,252 ESCC patients ranging fromT1N1-3M0 to T2-3N0-3M0were enrolled for interim analysis,with 127 in the toripalimab group and 125 in the chemotherapy group.The 1-year EFS rate was 77.9%in the toripalimab group compared to 64.3%in the chemotherapy group(hazard ratio[HR]=0.62;95%confidence interval[CI]=0.39 to 1.00;P=0.05).The 1-year OS rates were 94.1%and 83.0%in the toripalimab and chemotherapy groups,respectively(HR=0.48;95%CI=0.24 to 0.97;P=0.037).The patients in the toripalimab group had a higher pCR rate(18.6%vs.4.6%;P=0.001).The rates of postoperative Clavien-Dindo grade Ⅲb or higher morbidity were 9.8%in the toripalimab group and 6.8%in the chemotherapy group,with no significant difference observed(P=0.460).The rates of grade 3 or 4 treatment-related AEs did not differ between the two groups(12.5%versus 12.4%).Conclusions:The interim results of this ongoing trial showed that in resectable ESCC,the addition of perioperative tor
关 键 词：esophageal squamous cell carcinoma minimally invasive esophagectomy neoadjuvant chemotherapy neoadjuvant immunochemotherapy survival
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
正在载入数据...
