TY - JOUR
T1 - Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free Survival Among Women With Stage I Endometrial Cancer A Randomized Clinical Trial
AU - Janda, Monika
AU - Gebski, Val
AU - Davies, Lucy C.
AU - Forder, Peta
AU - Brand, Alison
AU - Hogg, Russell
AU - Jobling, Thomas W.
AU - Land, Russell
AU - Manolitsas, Tom
AU - Nascimento, Marcelo
AU - Neesham, Deborah
AU - Nicklin, James L.
AU - Oehler, Martin K.
AU - Otton, Geoff
AU - Perrin, Lewis
AU - Salfinger, Stuart
AU - Hammond, Ian
AU - Leung, Yee
AU - Sykes, Peter
AU - Ngan, Hextan
AU - Garrett, Andrea
AU - Laney, Michael
AU - Ng, Tong Yow
AU - Tam, Karfai
AU - Chan, Karen
AU - Wrede, C. David
AU - Pather, Selvan
AU - Simcock, Bryony
AU - Farrell, Rhonda
AU - Robertson, Gregory
AU - Walker, Graeme
AU - Armfield, Nigel R.
AU - Graves, Nick
AU - McCartney, Anthony J.
AU - Obermair, Andreas
PY - 2017/3/28
Y1 - 2017/3/28
N2 - 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.
AB - 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.
KW - MINIMALLY INVASIVE SURGERY
KW - ROUTINE FOLLOW-UP
KW - PATHOLOGICAL OUTCOMES
KW - ASSISTED RESECTION
KW - RECTAL-CANCER
KW - RECURRENCE
KW - CARCINOMA
KW - PATTERNS
KW - SAFETY
U2 - 10.1001/jama.2017.2068
DO - 10.1001/jama.2017.2068
M3 - Article
C2 - 28350928
VL - 317
SP - 1224
EP - 1233
JO - JAMA: The Journal of the American Medical Association
JF - JAMA: The Journal of the American Medical Association
SN - 0098-7484
IS - 12
ER -
