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Original Investigation
March 28, 2017

Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free Survival Among Women With Stage I Endometrial CancerA Randomized Clinical Trial

Author Affiliations
  • 1School of Public Health and Social Work, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia
  • 2NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia
  • 3Research Centre for Generational Health and Ageing, University of Newcastle, Newcastle, Australia
  • 4Westmead Hospital, Department of Gynaecologic Oncology, Sydney, Australia
  • 5University of Sydney and Northern Sydney Local Health District, Sydney, Australia
  • 6Department of Gynaecologic Oncology, Monash Medical Centre, Melbourne, Australia
  • 7Queensland Centre for Gynaecological Cancer, University of Queensland, Herston, Australia
  • 8School of Medicine, University of Queensland, Herston, Australia
  • 9Box Hill Hospital, Melbourne, Australia
  • 10Royal Women’s Hospital, Melbourne, Australia
  • 11Department of Gynaecology, Royal Adelaide Hospital, Adelaide, Australia
  • 12John Hunter Hospital, Newcastle, Australia
  • 13Department of Gynaecologic Oncology, University of Newcastle, Callaghan, Australia
  • 14St John of God Hospital, Perth, Australia
  • 15Gynaecological Cancer Service, King Edward Memorial Hospital, Subiaco, Australia
  • 16University of Notre Dame, Perth, Australia
  • 17School of Women’s and Infants’ Health, University of Western Australia, Perth
  • 18Christchurch Women’s Hospital, Christchurch, New Zealand
  • 19Department of Obstetrics and Gynecology, Queen Mary Hospital, Hong Kong
  • 20Royal Prince Alfred Hospital, Sydney, Australia
  • 21School of Women’s and Children’s Health, University of New South Wales, St George Hospital, Sydney, Australia
JAMA. 2017;317(12):1224-1233. doi:10.1001/jama.2017.2068
Key Points

Question  Is total laparoscopic hysterectomy equivalent to total abdominal hysterectomy for early-stage endometrial cancer surgery?

Findings  In this clinical trial of 760 women with stage I endometrial cancer, disease-free survival at 4.5 years was 81.6% with total laparoscopic hysterectomy vs 81.3% with total abdominal hysterectomy (difference, 0.3% [favoring total laparoscopic hysterectomy], 95% CI, −5.5% to 6.1%), meeting prespecified criteria for equivalence.

Meaning  In this trial of women with early-stage endometrial cancer, disease-free survival was equivalent following total laparoscopic hysterectomy compared with total abdominal hysterectomy. Laparoscopic hysterectomy is an appropriate approach for treatment of stage I endometrial cancer.

Abstract

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 follow-up, disease-free survival was 81.3% in the TAH group and 81.6% in the TLH group. The disease-free survival rate difference was 0.3% (favoring TLH; 95% CI, −5.5% to 6.1%; P = .007), meeting criteria for equivalence. There was no statistically significant between-group difference in recurrence of endometrial cancer (28/353 in TAH group [7.9%] vs 33/407 in TLH group [8.1%]; risk difference, 0.2% [95% CI, −3.7% to 4.0%]; P = .93) or in overall survival (24/353 in TAH group [6.8%] vs 30/407 in TLH group [7.4%]; risk difference, 0.6% [95% CI, −3.0% to 4.2%]; P = .76).

Conclusions and Relevance  Among women with stage I endometrial cancer, the use of total abdominal hysterectomy compared with total laparoscopic hysterectomy resulted in equivalent disease-free survival at 4.5 years and no difference in overall survival. These findings support the use of laparoscopic hysterectomy for women with stage I endometrial cancer.

Trial Registration  clinicaltrials.gov Identifier: NCT00096408; Australian New Zealand Clinical Trials Registry: CTRN12606000261516

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