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N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31.

Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer.

Author information

1
From the Department of Gynecologic Oncology and Reproductive Medicine, University of Texas M.D. Anderson Cancer Center, Houston (P.T.R., M.F., R.L.C.); the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Bogota, and Clínica de Oncología Astorga, Medellin - both in Colombia (R.P.); the Department of Gynecologic Surgery, Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru (A.L.); the Department of Gynecologic Oncology, Barretos Cancer Hospital, Barretos (M.V.), the Department of Surgical Oncology, Erasto Gaertner Hospital, Curitiba (R.R.), and the Department of Gynecologic Oncology, Albert Einstein Hospital, São Paulo (M.T.) - all in Brazil; the Unit of Gynecologic Oncology Surgery, Department of Obstetrics and Gynecology, San Gerardo Hospital, Monza, Italy (A.B.); the Department of Gynecology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou (X.Y.), the Department of Obstetrics and Gynecology, First Affiliated Hospital of Sun Yat-sen University, Guangzhou (Y.S.), and the Department of Gynecologic Oncology, Zhejiang Cancer Hospital, Hangzhou (T.Z.) - all in China; the Department of Gynecologic Oncology, Mater Health Services Brisbane, South Brisbane (N.C.), the National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney (K.P.R., V.G., R.A.), and the Queensland Centre for Gynaecological Cancer Research and the Faculty of Medicine, University of Queensland (V.B., A.O.), and the Department of Gynaecologic Oncology, Royal Brisbane and Women's Hospital (J.L.N.), Herston - all in Australia; and the Department of Gynecologic Oncology, Instituto Nacional de Cancerología, Mexico City (D.I.).

Abstract

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 IB1 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 disease-free 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. (Funded by the University of Texas M.D. Anderson Cancer Center and Medtronic; LACC ClinicalTrials.gov number, NCT00614211 .).

PMID:
30380365
DOI:
10.1056/NEJMoa1806395
[Indexed for MEDLINE]

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