Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial

doi:10.1200/JCO.2018.79.1483

科研成果详情

题名	Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial
作者	Yang, Hong 1; Liu, Hui 1; Chen, Yuping 2; Zhu, Chengchu4; Fang, Wentao 6; Yu, Zhentao 8; Mao, Weimin 5; Xiang, Jiaqing 7; Han, Yongtao 9; Chen, Zhijian 2,3; Yang, Haihua4; Wang, Jiaming 6; Pang, Qingsong 8; Zheng, Xiao 5; Yang, Huanjun 7; Li, Tao 9; Lordick, Florian 10; D'Journo, Xavier Benoit 12; Cerfolio, Robert J.13; Korst, Robert J.14,15; Novoa, Nuria M.16; Swanson, Scott J.17; Brunelli, Alessandro 18; Ismail, Mahmoud 11; Fernando, Hiran C.19; Zhang, Xu 1; Li, Qun 1; Wang, Geng 2; Chen, Baofu4; Mao, Teng 6; Kong, Min4; Guo, Xufeng 6; Lin, Ting 1; Liu, Mengzhong 1; Fu, Jianhua 1
发表日期	2018-09-20
发表期刊	JOURNAL OF CLINICAL ONCOLOGY 影响因子和分区
语种	英语
原始文献类型	Article
其他关键词	LYMPH-NODE DISSECTION ; CERVICAL ESOPHAGOGASTROSTOMY ; TRANSTHORACIC ESOPHAGECTOMY ; PLUS SURGERY ; CANCER ; THERAPY ; CHEMOTHERAPY ; RADIOTHERAPY
摘要	PurposeThe efficacy of neoadjuvant chemoradiotherapy (NCRT) plus surgery for locally advanced esophageal squamous cell carcinoma (ESCC) remains controversial. In this trial, we compared the survival and safety of NCRT plus surgery with surgery alone in patients with locally advanced ESCC.Patients and MethodsFrom June 2007 to December 2014, 451 patients with potentially resectable thoracic ESCC, clinically staged as T1-4N1M0/T4N0M0, were randomly allocated to NCRT plus surgery (group CRT; n = 224) and surgery alone (group S; n = 227). In group CRT, patients received vinorelbine 25 mg/m(2) intravenously (IV) on days 1 and 8 and cisplatin 75 mg/m(2) IV day 1, or 25 mg/m(2) IV on days 1 to 4 every 3 weeks for two cycles, with a total concurrent radiation dose of 40.0 Gy administered in 20 fractions of 2.0 Gy on 5 days per week. In both groups, patients underwent McKeown or Ivor Lewis esophagectomy. The primary end point was overall survival.ResultsThe pathologic complete response rate was 43.2% in group CRT. Compared with group S, group CRT had a higher R0 resection rate (98.4% v 91.2%; P = .002), a better median overall survival (100.1 months v 66.5 months; hazard ratio, 0.71; 95% CI, 0.53 to 0.96; P = .025), and a prolonged disease-free survival (100.1 months v 41.7 months; hazard ratio, 0.58; 95% CI, 0.43 to 0.78; P < .001). Leukopenia (48.9%) and neutropenia (45.7%) were the most common grade 3 or 4 adverse events during chemoradiotherapy. Incidences of postoperative complications were similar between groups, with the exception of arrhythmia (group CRT: 13% v group S: 4.0%; P = .001). Peritreatment mortality was 2.2% in group CRT versus 0.4% in group S (P = .212).ConclusionThis trial shows that NCRT plus surgery improves survival over surgery alone among patients with locally advanced ESCC, with acceptable and manageable adverse events.
资助项目	Health Ministry of China [179]; Sun Yat-sen University Clinical Research 5010 Program [2007048]; National Science Foundation of ChinaNational Natural Science Foundation of China (NSFC) [81272635]; Science and Technology Fund for Projects of Guangdong Province [2012A030400007]; Major Science and Technology Special Fund for Projects of Zhejiang Province [2011C13039-2]
出版者	LIPPINCOTT WILLIAMS & WILKINS
出版地	PHILADELPHIA
ISSN	0732-183X
EISSN	1527-7755
卷号	36 期号:27 页码:2796-+
DOI	10.1200/JCO.2018.79.1483
页数	15
WOS类目	Oncology
WOS研究方向	Oncology
WOS记录号	WOS:000451484000008
收录类别	SCIE ; PUBMED ; SCOPUS
URL	查看原文
PubMed ID	30089078
PMC记录号	PMC6145832
SCOPUSEID	2-s2.0-85053700499
ESI高被引论文	2020-09 ; 2020-11 ; 2021-01 ; 2021-03 ; 2021-05 ; 2021-07 ; 2021-11 ; 2022-01 ; 2022-03 ; 2022-07 ; 2022-09 ; 2022-11 ; 2023-01 ; 2023-03 ; 2023-05 ; 2023-07 ; 2023-09 ; 2023-11 ; 2024-01 ; 2024-03 ; 2024-05 ; 2024-07 ; 2024-09 ; 2024-11
自科自定义期刊分类	T2(A)类
通讯作者地址	[Fu, Jianhua]Sun Yat Sen Univ, State Key Lab Oncol South China, Guangdong Esophageal Canc Inst,Canc Ctr, Dept Thorac Surg,Collaborat Innovat Ctr Canc Med, Guangzhou 510060, Guangdong, Peoples R China.
Scopus学科分类	Oncology;Cancer Research
TOP期刊	TOP期刊
引用统计	被引频次：334[WOS] [WOS记录] [WOS相关记录]
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/20809
专题	其他_附属台州医院（浙江省台州医院）附属台州医院
通讯作者	Fu, Jianhua
作者单位	1.Sun Yat Sen Univ, Ctr Canc, Guangzhou, Guangdong, Peoples R China; 2.Shantou Univ, Coll Med, Canc Hosp, Shantou, Peoples R China; 3.Univ Hong Kong Shenzhen Hosp, Shenzhen, Guangdong, Peoples R China; 4.Wenzhou Med Univ, Taizhou Hosp, Linhai, Peoples R China; 5.Zhejiang Canc Hosp, Hangzhou, Zhejiang, Peoples R China; 6.Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai, Peoples R China; 7.Fudan Univ, Shanghai Canc Ctr, Shanghai, Peoples R China; 8.Tianjin Med Univ, Canc Hosp, Tianjin, Peoples R China; 9.Sichuan Canc Hosp, Chengdu, Sichuan, Peoples R China; 10.Univ Med Leipzig, Univ Canc Ctr Leipzig, Leipzig, Germany; 11.Humboldt Univ, Acad Hosp, Charite Univ Med, Berlin, Germany; 12.Aix Marseille Univ, Hop Nord, Chemin Bourrely, Marseille, France; 13.New York Univ Langone Hlth, New York, NY USA; 14.Mt Sinai Hlth Syst, Icahn Sch Med, New York, NY USA; 15.Valley Mt Sinai Comprehens Canc Care, Paramus, NJ USA; 16.Univ Hosp Salamanca, Salamanca, Spain; 17.Harvard Med Sch, Dana Farber Canc Inst, Brigham & Womens Hosp, Boston, MA USA; 18.St James Univ Hosp, Leeds, W Yorkshire, England; 19.Inova Fairfax Med Ctr, Inova Schar Canc Inst, Falls Church, VA USA
推荐引用方式 GB/T 7714	Yang, Hong,Liu, Hui,Chen, Yuping,et al. Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial[J]. JOURNAL OF CLINICAL ONCOLOGY,2018,36(27):2796-+.
APA	Yang, Hong., Liu, Hui., Chen, Yuping., Zhu, Chengchu., Fang, Wentao., ... & Fu, Jianhua. (2018). Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial. JOURNAL OF CLINICAL ONCOLOGY, 36(27), 2796-+.
MLA	Yang, Hong,et al."Neoadjuvant Chemoradiotherapy Followed by Surgery Versus Surgery Alone for Locally Advanced Squamous Cell Carcinoma of the Esophagus (NEOCRTEC5010): A Phase III Multicenter, Randomized, Open-Label Clinical Trial".JOURNAL OF CLINICAL ONCOLOGY 36.27(2018):2796-+.