Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free Survival Among Women With Stage I Endometrial Cancer

作者：Monika Janda, Val Gebski, Lucy Claire Davies, Peta Forder, Alison H. Brand, Russell J. Hogg, Thomas W. Jobling, Russell Land, Tom Manolitsas, Marcelo Nascimento, Deborah Neesham, James Nicklin, Martin Klaus Oehler, Geoff Otton, Lewis C Perrin, Stuart G. Salfinger, Ian G Hammond, Yee Chit Leung, Peter H. Sykes, Hys Ngan, Andrea Garrett, Michael Laney, Tong Yow Ng, Kar‐Fai Tam, Karen K. L. Chan, Casper David Wrede, Selvan Pather, Bryony J. Simcock, Rhonda Farrell, Gregory C. Robertson, Graeme Walker, Nigel R Armfield, Nick Graves, Anthony J. McCartney, Andreas Obermair · 发表于：JAMA · 年份：2017 · DOI：10.1001/jama.2017.2068 · 被引用次数：453 · 研究领域：Endometrial and Cervical Cancer Treatments、Gynecological conditions and treatments、Uterine Myomas and Treatments

Importance: Standard treatment for endometrial cancer involves removal of the uterus, tubes, ovaries, and lymph nodes. Few randomized trials have compared disease-free survival outcomes for surgical approaches. Objective: To investigate whether total laparoscopic hysterectomy (TLH) is equivalent to total abdominal hysterectomy (TAH) in women with treatment-naive endometrial cancer. Design, Setting, and Participants: The Laparoscopic Approach to Cancer of the Endometrium (LACE) trial was a multinational, randomized equivalence trial conducted between October 7, 2005, and June 30, 2010, in which 27 surgeons from 20 tertiary gynecological cancer centers in Australia, New Zealand, and Hong Kong randomized 760 women with stage I endometrioid endometrial cancer to either TLH or TAH. Follow-up ended on March 3, 2016. Interventions: Patients were randomly assigned to undergo TAH (n = 353) or TLH (n = 407). Main Outcomes and Measures: The primary outcome was disease-free survival, which was measured as the interval between surgery and the date of first recurrence, including disease progression or the development of a new primary cancer or death assessed at 4.5 years after randomization. The prespecified equivalence margin was 7% or less. Secondary outcomes included recurrence of endometrial cancer and overall survival. Results: Patients were followed up for a median of 4.5 years. Of 760 patients who were randomized (mean age, 63 years), 679 (89%) completed the trial. At 4.5 years of f...