Use of either surgery resulted in equivalent disease-free survival and no difference in overall survival.
The use of less-invasive total laparoscopic hysterectomy (TLH) was found to be equivalent in disease-free survival to total abdominal hysterectomy (TAH) in patients with early-stage endometrial cancer. Furthermore, no difference was observed in overall survival.
The standard treatment for endometrial cancer involves the surgical removal of the uterus, tubes, ovaries, and lymph nodes. To date, there have been few randomized trials that compare disease-free survival outcomes for surgical approaches.
Laparoscopic hysterectomy has been associated with less morbidity and superior recovery than open operations. However, it was unknown if the survival outcomes from the operation were equivalent to abdominal hysterectomy.
The multinational, randomized LACE equivalence trial was conducted between October 7, 2005, and June 30, 2010. Twenty-seven surgeons from 20 tertiary gynecological cancer centers in Australia, New Zealand, and Hong Kong randomized 760 women with stage 1 endometrial cancer to undergo either TLH or TAH.
The primary outcome was disease-free survival, 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. Secondary outcomes included recurrence of endometrial cancer and overall survival.
Patients were followed up for a median of 4.5 years. Of the 760 patients, 679 completed the trial.
The results of the study, published in JAMA, found that at 4.5 years, disease-free survival was 81.3% in the TAH arm and 81.6% in the TLH group. The disease-free survival rate difference was 0.3%, favoring TLH, and meeting the criteria for equivalence.
No statistically significant difference was found between the groups in recurrence of endometrial cancer.
“In this trial of women with early-stage endometrial cancer, disease-free survival was equivalent following total laparoscopic hysterectomy compared with total abdominal hysterectomy,” the authors concluded. “Laparoscopic hysterectomy is an appropriate approach for treatment of stage 1 endometrial cancer.”