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

<b>IMPORTANCE </b> Current standard treatment for endometrial cancer involves removal of uterus, adnexa ± lymph nodes. Few randomized trials have compared disease-free survival outcomes for surgical approaches. <b>OBJECTIVE </b> To investigate whether total laparoscopic hysterectomy (TLH) is equivalent to total abdominal hysterectomy (TAH) in women with treatment-naive endometrial cancer. <b>DESIGN, SETTING, AND PARTICIPANTS </b> Multinational, randomized equivalence trial evaluating the laparoscopic approach to endometrial cancer (LACE). Between October 7, 2005 and June 30, 2010, 27 surgeons from 20 tertiary gynaecological cancer centres in Australia, New Zealand, and Hong Kong randomised 760 women with stage I endometrioid endometrial cancer to either TLH or TAH. Follow-up ended 3rd March 2016. <b>INTERVENTIONS </b> 353 patients were randomized to TAH, 407 to TLH. <b>MAIN OUTCOMES AND MEASURES </b> Analysis according to intention-to-treat assessed the primary outcome of disease-free survival (DFS, time interval between surgery and date of first recurrence including any new localized or distant endometrial cancer recurrence or any new cancers, at 4.5 years post-randomization). The pre-specified equivalence boundary was ∆=±7%. Among seven pre-specified secondary outcomes, disease recurrence and overall survival are reported. <b>RESULTS </b> Patients were followed 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 follow-up, DFS was 81.3% in the TAH and 81.6% in the TLH group. Equivalence was established with a DFS rate difference of 0.3% (favoring TLH) [95% CI: -5.53% to 6.13], p for equivalence =0.007. There was no statistical difference in endometrial cancer recurrences between the two groups (TAH 28 of 353 (7.9%) and TLH 33 of 407 (8.1%), risk difference 0.2%, 95% CI: -3.7 to 4.0%, p=0.93) or in overall survival (TAH 24 of 353 (6.8%) and TLH 30 of 407 (7.4%), risk difference 0.6%, 95% CI: -3.0 to 4.2%, p=0.76). <b>CONCLUSIONS AND RELEVANCE </b> Among women with stage I endometrioid endometrial cancer, the use of TAH compared with TLH resulted in equivalent DFS at 4.5 years and no difference in overall survival was observed. These findings support the use of laparoscopic hysterectomy for stage 1 endometrial cancer.