title: Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free Survival Among Women With Stage I Endometrial Cancer: A Randomized Clinical Trial.
abstract: 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.
  
  
  
  To investigate whether total laparoscopic hysterectomy (TLH) is equivalent to total abdominal hysterectomy (TAH) in women with treatment-naive endometrial cancer.
  
  
  
  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.
  
  
  
  Patients were randomly assigned to undergo TAH (n = 353) or TLH (n = 407).
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  clinicaltrials.gov Identifier: NCT00096408; Australian New Zealand Clinical Trials Registry: CTRN12606000261516.
authors.affiliation: School of Public Health and Social Work, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia.
authors.forename: Monika
authors.initials: M
authors.lastname: Janda
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
authors.forename: Val
authors.initials: V
authors.lastname: Gebski
authors.affiliation: NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.
authors.forename: Lucy C
authors.initials: LC
authors.lastname: Davies
authors.affiliation: Research Centre for Generational Health and Ageing, University of Newcastle, Newcastle, Australia.
authors.forename: Peta
authors.initials: P
authors.lastname: Forder
authors.affiliation: Westmead Hospital, Department of Gynaecologic Oncology, Sydney, Australia.
authors.forename: Alison
authors.initials: A
authors.lastname: Brand
authors.affiliation: University of Sydney and Northern Sydney Local Health District, Sydney, Australia.
authors.forename: Russell
authors.initials: R
authors.lastname: Hogg
authors.affiliation: Department of Gynaecologic Oncology, Monash Medical Centre, Melbourne, Australia.
authors.forename: Thomas W
authors.initials: TW
authors.lastname: Jobling
authors.affiliation: Queensland Centre for Gynaecological Cancer, University of Queensland, Herston, Australia8School of Medicine, University of Queensland, Herston, Australia.
authors.forename: Russell
authors.initials: R
authors.lastname: Land
authors.affiliation: Box Hill Hospital, Melbourne, Australia.
authors.forename: Tom
authors.initials: T
authors.lastname: Manolitsas
authors.affiliation: Queensland Centre for Gynaecological Cancer, University of Queensland, Herston, Australia8School of Medicine, University of Queensland, Herston, Australia.
authors.forename: Marcelo
authors.initials: M
authors.lastname: Nascimento
authors.affiliation: Royal Women's Hospital, Melbourne, Australia.
authors.forename: Deborah
authors.initials: D
authors.lastname: Neesham
authors.affiliation: Queensland Centre for Gynaecological Cancer, University of Queensland, Herston, Australia8School of Medicine, University of Queensland, Herston, Australia.
authors.forename: James L
authors.initials: JL
authors.lastname: Nicklin
authors.affiliation: Department of Gynaecology, Royal Adelaide Hospital, Adelaide, Australia.
authors.forename: Martin K
authors.initials: MK
authors.lastname: Oehler
authors.affiliation: John Hunter Hospital, Newcastle, Australia13Department of Gynaecologic Oncology, University of Newcastle, Callaghan, Australia.
authors.forename: Geoff
authors.initials: G
authors.lastname: Otton
authors.affiliation: Queensland Centre for Gynaecological Cancer, University of Queensland, Herston, Australia8School of Medicine, University of Queensland, Herston, Australia.
authors.forename: Lewis
authors.initials: L
authors.lastname: Perrin
authors.affiliation: St John of God Hospital, Perth, Australia15Gynaecological Cancer Service, King Edward Memorial Hospital, Subiaco, Australia16University of Notre Dame, Perth, Australia17School of Women's and Infants' Health, University of Western Australia, Perth.
authors.forename: Stuart
authors.initials: S
authors.lastname: Salfinger
authors.affiliation: School of Women's and Infants' Health, University of Western Australia, Perth.
authors.forename: Ian
authors.initials: I
authors.lastname: Hammond
authors.affiliation: St John of God Hospital, Perth, Australia15Gynaecological Cancer Service, King Edward Memorial Hospital, Subiaco, Australia17School of Women's and Infants' Health, University of Western Australia, Perth.
authors.forename: Yee
authors.initials: Y
authors.lastname: Leung
authors.affiliation: Christchurch Women's Hospital, Christchurch, New Zealand.
authors.forename: Peter
authors.initials: P
authors.lastname: Sykes
authors.affiliation: Department of Obstetrics and Gynecology, Queen Mary Hospital, Hong Kong.
authors.forename: Hextan
authors.initials: H
authors.lastname: Ngan
authors.affiliation: Queensland Centre for Gynaecological Cancer, University of Queensland, Herston, Australia8School of Medicine, University of Queensland, Herston, Australia.
authors.forename: Andrea
authors.initials: A
authors.lastname: Garrett
authors.affiliation: Christchurch Women's Hospital, Christchurch, New Zealand.
authors.forename: Michael
authors.initials: M
authors.lastname: Laney
authors.affiliation: Department of Obstetrics and Gynecology, Queen Mary Hospital, Hong Kong.
authors.forename: Tong Yow
authors.initials: TY
authors.lastname: Ng
authors.affiliation: Department of Obstetrics and Gynecology, Queen Mary Hospital, Hong Kong.
authors.forename: Karfai
authors.initials: K
authors.lastname: Tam
authors.affiliation: Department of Obstetrics and Gynecology, Queen Mary Hospital, Hong Kong.
authors.forename: Karen
authors.initials: K
authors.lastname: Chan
authors.affiliation: Royal Women's Hospital, Melbourne, Australia.
authors.forename: C David
authors.initials: CD
authors.lastname: Wrede
authors.affiliation: Royal Prince Alfred Hospital, Sydney, Australia.
authors.forename: Selvan
authors.initials: S
authors.lastname: Pather
authors.affiliation: Christchurch Women's Hospital, Christchurch, New Zealand.
authors.forename: Bryony
authors.initials: B
authors.lastname: Simcock
authors.affiliation: School of Women's and Children's Health, University of New South Wales, St George Hospital, Sydney, Australia.
authors.forename: Rhonda
authors.initials: R
authors.lastname: Farrell
authors.affiliation: School of Women's and Children's Health, University of New South Wales, St George Hospital, Sydney, Australia.
authors.forename: Gregory
authors.initials: G
authors.lastname: Robertson
authors.affiliation: Queensland Centre for Gynaecological Cancer, University of Queensland, Herston, Australia.
authors.forename: Graeme
authors.initials: G
authors.lastname: Walker
authors.affiliation: Queensland Centre for Gynaecological Cancer, University of Queensland, Herston, Australia8School of Medicine, University of Queensland, Herston, Australia.
authors.forename: Nigel R
authors.initials: NR
authors.lastname: Armfield
authors.affiliation: School of Public Health and Social Work, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia.
authors.forename: Nick
authors.initials: N
authors.lastname: Graves
authors.affiliation: St John of God Hospital, Perth, Australia15Gynaecological Cancer Service, King Edward Memorial Hospital, Subiaco, Australia.
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: McCartney
authors.affiliation: Queensland Centre for Gynaecological Cancer, University of Queensland, Herston, Australia8School of Medicine, University of Queensland, Herston, Australia.
authors.forename: Andreas
authors.initials: A
authors.lastname: Obermair
mesh_terms: D000368:Aged; D001315:Australia; D018450:Disease Progression; D018572:Disease-Free Survival; D016889:Endometrial Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D006723:Hong Kong; D006801:Humans; D007044:Hysterectomy / Q000379:methods* / Q000401:mortality; D057194:Intention to Treat Analysis; D010535:Laparoscopy; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009366:Neoplasm Seeding; D016609:Neoplasms, Second Primary; D009520:New Zealand; D013997:Time Factors