Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy for Stage I Endometrial Cancer
A multinational equivalence trial has shown no difference in disease-free survival with total laparoscopic hysterectomy vs total abdominal hysterectomy in women with treatment-naive stage I endometrial cancer. The findings were reported by Janda et al in JAMA.
Study Details
In the trial, 760 women with endometrial cancer from 20 tertiary gynecologic cancer centers (27 surgeons) in Australia, New Zealand, and Hong Kong were randomized between October 2005 and June 2010 to undergo total abdominal hysterectomy (n = 353) or total laparoscopic hysterectomy (n = 407). The primary outcome measure was disease-free survival at 4.5 years after randomization in the intent-to-treat population, with an equivalence margin of ≤ 7%.
Patients in the total abdominal hysterectomy and total laparoscopic hysterectomy groups had a mean age of 63 years in both (44% and 43% ≥ 65 years), 63% and 60% had a body mass index ≥ 30 kg/m2, 6.6% and 9.2% had a prior malignancy, and 55% and 57% had a Charlson comorbidity index ≥ 3.
Disease-Free Survival
Median follow-up was 4.5 years. At 4.5 years, disease-free survival was 81.3% in the total abdominal hysterectomy group vs 81.6% in the total laparoscopic hysterectomy group; the rate difference was 0.3%, meeting the criteria for equivalence (P = .007). The hazard ratio (HR) for disease-free survival was 1.03 (P = .87). Recurrence of endometrial cancer was observed in 7.9% vs 8.1% of patients (P = .93). Overall survival at 4.5 years was 92.4% vs 92.0% (HR = 1.08, P = .78).
The investigators concluded: “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.”
This study was funded by the Cancer Council Queensland, Cancer Council New South Wales, Cancer Council Victoria, and Cancer Council Western Australia, among others.
Andreas Obermair, MD, of Royal Brisbane and Women’s Hospital, is the corresponding author of the JAMA article.
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