Monika Janda1, Val Gebski2, Lucy C Davies2, Peta Forder3, Alison Brand4, Russell Hogg5, Thomas W Jobling6, Russell Land7, Tom Manolitsas8, Marcelo Nascimento7, Deborah Neesham9, James L Nicklin7, Martin K Oehler10, Geoff Otton11, Lewis Perrin7, Stuart Salfinger12, Ian Hammond13, Yee Leung14, Peter Sykes15, Hextan Ngan16, Andrea Garrett7, Michael Laney15, Tong Yow Ng16, Karfai Tam16, Karen Chan16, C David Wrede9, Selvan Pather17, Bryony Simcock15, Rhonda Farrell18, Gregory Robertson18, Graeme Walker19, Nigel R Armfield7, Nick Graves1, Anthony J McCartney20, Andreas Obermair7. 1. School of Public Health and Social Work, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia. 2. NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia. 3. Research Centre for Generational Health and Ageing, University of Newcastle, Newcastle, Australia. 4. Westmead Hospital, Department of Gynaecologic Oncology, Sydney, Australia. 5. University of Sydney and Northern Sydney Local Health District, Sydney, Australia. 6. Department of Gynaecologic Oncology, Monash Medical Centre, Melbourne, Australia. 7. Queensland Centre for Gynaecological Cancer, University of Queensland, Herston, Australia8School of Medicine, University of Queensland, Herston, Australia. 8. Box Hill Hospital, Melbourne, Australia. 9. Royal Women's Hospital, Melbourne, Australia. 10. Department of Gynaecology, Royal Adelaide Hospital, Adelaide, Australia. 11. John Hunter Hospital, Newcastle, Australia13Department of Gynaecologic Oncology, University of Newcastle, Callaghan, Australia. 12. 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. 13. School of Women's and Infants' Health, University of Western Australia, Perth. 14. 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. 15. Christchurch Women's Hospital, Christchurch, New Zealand. 16. Department of Obstetrics and Gynecology, Queen Mary Hospital, Hong Kong. 17. Royal Prince Alfred Hospital, Sydney, Australia. 18. School of Women's and Children's Health, University of New South Wales, St George Hospital, Sydney, Australia. 19. Queensland Centre for Gynaecological Cancer, University of Queensland, Herston, Australia. 20. St John of God Hospital, Perth, Australia15Gynaecological Cancer Service, King Edward Memorial Hospital, Subiaco, Australia.
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 eitherTLH 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.
RCT Entities:
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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