Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer

doi:10.1056/NEJMoa1806395

科研成果详情

题名	Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer
作者	Ramirez, Pedro T.1; Frumovitz, Michael 1; Pareja, Rene 2; Lopez, Aldo 3; Vieira, Marcelo 4; Ribeiro, Reitan 5; Buda, Alessandro 7; Yan, Xiaojian8; Shuzhong, Yao 9; Chetty, Naven 11; Isla, David 15; Tamura, Mariano 6; Zhu, Tao 10; Robledo, Kristy P.12; Gebski, Val 12; Asher, Rebecca 12; Behan, Vanessa 13; Nicklin, James L.14; Coleman, Robert L.1; Obermair, Andreas 13
发表日期	2018-11-15
发表期刊	NEW ENGLAND JOURNAL OF MEDICINE 影响因子和分区
语种	英语
原始文献类型	Article
其他关键词	RANDOMIZED CLINICAL-TRIAL ; LAPAROSCOPIC-ASSISTED RESECTION ; GYNECOLOGIC-ONCOLOGY ; PATHOLOGICAL OUTCOMES ; SURVIVAL OUTCOMES ; RECTAL-CANCER ; SURGERY ; METAANALYSIS ; LAPAROTOMY ; EXPERIENCE
摘要	BACKGROUND There are limited data from retrospective studies regarding whether survival outcomes after laparoscopic or robot-assisted radical hysterectomy (minimally invasive surgery) are equivalent to those after open abdominal radical hysterectomy (open surgery) among women with early-stage cervical cancer. METHODS In this trial involving patients with stage IA1 (lymphovascular invasion), IA2, or IB1 cervical cancer and a histologic subtype of squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, we randomly assigned patients to undergo minimally invasive surgery or open surgery. The primary outcome was the rate of disease-free survival at 4.5 years, with noninferiority claimed if the lower boundary of the two-sided 95% confidence interval of the between-group difference (minimally invasive surgery minus open surgery) was greater than -7.2 percentage points (i.e., closer to zero). RESULTS A total of 319 patients were assigned to minimally invasive surgery and 312 to open surgery. Of the patients who were assigned to and underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% robot-assisted surgery. Overall, the mean age of the patients was 46.0 years. Most patients (91.9%) had stage I131 disease. The two groups were similar with respect to histologic subtypes, the rate of lymphovascular invasion, rates of parametrial and lymph-node involvement, tumor size, tumor grade, and the rate of use of adjuvant therapy. The rate of disease-free survival at 4.5 years was 86.0% with minimally invasive surgery and 96.5% with open surgery, a difference of-10.6 percentage points (95% confidence interval (CI), -16.4 to -4.7). Minimally invasive surgery was associated with a lower rate of diseasefree survival than open surgery (3-year rate, 91.2% vs. 97.1%; hazard ratio for disease recurrence or death from cervical cancer, 3.74; 95% CI, 1.63 to 8.58), a difference that remained after adjustment for age, body-mass index, stage of disease, lymphovascular invasion, and lymph-node involvement; minimally invasive surgery was also associated with a lower rate of overall survival (3-year rate, 93.8% vs. 99.0%; hazard ratio for death from any cause, 6.00; 95% CI, 1.77 to 20.30). CONCLUSIONS In this trial, minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer.
资助项目	Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center; MedtronicMedtronic
出版者	MASSACHUSETTS MEDICAL SOC
出版地	WALTHAM
ISSN	0028-4793
EISSN	1533-4406
卷号	379 期号:20 页码:1895-1904
DOI	10.1056/NEJMoa1806395
页数	10
WOS类目	Medicine, General & Internal
WOS研究方向	General & Internal Medicine
WOS记录号	WOS:000450049800004
收录类别	SCIE ; PUBMED ; SCOPUS
URL	查看原文
PubMed ID	30380365
SCOPUSEID	2-s2.0-85056625527
ESI热点论文	2020-01 ; 2020-03 ; 2020-05 ; 2020-09 ; 2020-11 ; 2021-01
ESI高被引论文	2020-03 ; 2020-05 ; 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	T1类
通讯作者地址	[Ramirez, Pedro T.]Department of Gynecologic Oncology and Reproductive Medicine,Unit 1362,University of Texas,M.D. Anderson Cancer Center,1515 Holcombe Blvd.,Houston,77030,United States
Scopus学科分类	Medicine (all)
TOP期刊	TOP期刊
引用统计	被引频次：885[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/20752
专题	附属第一医院
通讯作者	Ramirez, Pedro T.
作者单位	1.Department of Gynecologic Oncology and Reproductive Medicine,Unit 1362,University of Texas,M.D. Anderson Cancer Center,1515 Holcombe Blvd.,Houston,77030,United States; 2.Department of Gynecologic Oncology,Instituto Nacional de Cancerología,Bogota,and Clínica de Oncología Astorga,Medellin,Colombia; 3.Department of Gynecologic Surgery,Instituto Nacional de Enfermedades Neoplásicas,Lima,Peru; 4.Department of Gynecologic Oncology,Barretos Cancer Hospital,Barretos,Brazil; 5.Department of Surgical Oncology,Erasto Gaertner Hospital,Curitiba,Brazil; 6.Department of Gynecologic Oncology,Albert Einstein Hospital,São Paulo,Brazil; 7.Unit of Gynecologic Oncology Surgery,Department of Obstetrics and Gynecology,San Gerardo Hospital,Monza,Italy; 8.Department of Gynecology,First Affiliated Hospital of Wenzhou Medical University,Wenzhou,China; 9.Department of Obstetrics and Gynecology,First Affiliated Hospital of Sun Yat-sen University,Guangzhou,China; 10.Department of Gynecologic Oncology,Zhejiang Cancer Hospital,Hangzhou,China; 11.Department of Gynecologic Oncology,Mater Health Services Brisbane,South Brisbane,United States; 12.National Health and Medical Research,Council Clinical Trials Centre,University of Sydney,Sydney,Australia; 13.Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine,University of Queensland,Australia; 14.Department of Gynaecologic Oncology,Royal Brisbane and Women's Hospital,Herston,Australia; 15.Department of Gynecologic Oncology,Instituto Nacional de Cancerología,Mexico City,Mexico
推荐引用方式 GB/T 7714	Ramirez, Pedro T.,Frumovitz, Michael,Pareja, Rene,et al. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer[J]. NEW ENGLAND JOURNAL OF MEDICINE,2018,379(20):1895-1904.
APA	Ramirez, Pedro T.., Frumovitz, Michael., Pareja, Rene., Lopez, Aldo., Vieira, Marcelo., ... & Obermair, Andreas. (2018). Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. NEW ENGLAND JOURNAL OF MEDICINE, 379(20), 1895-1904.
MLA	Ramirez, Pedro T.,et al."Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer".NEW ENGLAND JOURNAL OF MEDICINE 379.20(2018):1895-1904.