Laparoscopic or open hysterectomy without lymph node dissection for early endometrial cancer (EC) led to similar disease control and survival, a randomized study from the Netherlands showed.
The 5-year landmark analyses all favored minimally invasive surgery, including disease-free survival (DFS; 90.3% vs 84.1%), overall survival (OS; 89.2% vs 82.8%), and disease-specific survival (DSS; 95.0% vs 89.8%). Cancer recurrence rates were similar, and laparoscopic hysterectomy was not associated with port-site or wound metastases.
The results add to data from previous studies supporting total laparoscopic hysterectomy (TLH) without lymphadenectomy as a standard-of-care procedure for early endometrial cancer, concluded Marian J.E. Mourits, MD, of University Medical Center Groningen, and co-authors in Gynecologic Oncology.
“This is the first study on long-term survival among women with early-stage EC undergoing TLH or TAH [total abdominal hysterectomy] without lymphadenectomy,” the authors wrote in conclusion. “Women showed comparable DFS rates after both surgical treatments. Combined with previous reports of improved short-term surgical outcomes, these results support the widespread use of TLH as the primary treatment for early-stage, low-grade EC.”
The incidence of endometrial cancer has increased steadily with the key risk factors of obesity and aging. Postmenopausal bleeding is a prominent early symptom of the cancer, and about 80% of women have early-stage disease at diagnosis. Most women have a good prognosis, with a 5-year survival rate of 84%, the authors noted.
Historically, TAH with bilateral salpingo-oophorectomy has been the standard of care for early endometrial cancer, but adoption of TLH has steadily increased since its introduction. Because most patients have early disease at diagnosis, the risk of lymph node metastasis is low, and clinical guidelines have omitted systematic lymphadenectomy, the authors continued.
Multiple clinical trials established the safety of TLH versus TAH, including reduced blood loss, pain, and hospital stay, as well as faster recovery and improved quality of life. However, few studies have provided data on the long-term safety and oncologic outcomes of TLH for early endometrial cancer. The multicenter randomized LACE and LAP2 trials showed comparable OS and DFS with laparoscopic and open hysterectomy but advocated for routine lymphadenectomy.
Mourits and colleagues reported 5-year follow-up data from a randomized comparison of TLH and TAH without lymphadenectomy. From 2007 to 2009, investigators at 19 Dutch centers enrolled patients with stage I low-grade endometrial cancer and randomly allocated them 2:1 to TLH or TAH, omitting lymphadenectomy in accordance with national standards.
As previously reported, the initial results showed no significant difference in major complications between the two groups. Patients consented to follow-up for 5 years after surgery. The primary outcomes of the long-term follow-up were DFS, OS, DSS, and sites of recurrence.
The 5-year data analysis included 263 of the original 279 randomized patients. Median follow-up was 5.0 years for the patients allocated to TLH and 4.8 years for those who underwent TAH. Adjuvant therapy was administered to 20.7% of the TLH group and to 27.3% of the TAH group.
At 5 years, 29 patients had developed recurrence, 16 (9.7%) in the TLH arm and 13 (15.9%) in the TAH arm. The median time to recurrence was 1.5 years in the TLH group and 1.1 years following TAH. Two patients in each group had recurrence only in the vaginal vault. The primary outcomes all favored TLH and met prespecified statistical criteria for noninferiority versus TAH.
- DFS: HR 0.69, 95% CI 0.31-1.52
- OS: HR 0.60, 95% CI 0.30-1.19
- DSS: HR 0.62, 95% CI 0.23-1.70
“The current randomized controlled multicenter TLH-TAH trial provides data in a real-life setting in the Netherlands,” the authors wrote. “The procedures were performed in both teaching and nonteaching hospitals and only by trained, experienced surgeons. … The results of this follow-up study complement the present literature, mainly in Europe, where lymphadenectomy is not a standard surgical procedure for early-stage, low-grade EC.”
In addition to the LAP2 and LACE trials, a study published in December showed similar oncologic outcomes with TLH and TAH in high-risk endometrial cancer, said Pedro Ramirez, MD, of the University of Texas MD Anderson Cancer Center in Houston. The findings reported by Mourits and colleagues “just add to what is already known in the literature regarding the safety of the laparoscopic approach.”
“As it pertains to lymphadenectomy, it is a well-known fact that patients of low risk do not require a lymphadenectomy, as the risk of lymph node metastases is very low (MedPage Today via email. “In addition, this study has significant flaws in the fact that data accuracy and completeness come in question, given that some of the ‘patient data was lost’ according to the investigators. Overall, this study does not add much in terms of novel data.”
Charles Bankhead is senior editor for oncology and also covers urology, dermatology, and ophthalmology. He joined MedPage Today in 2007. Follow
The authors reported having no relevant relationships with industry.