LACE Study

Effect of Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy on Disease-Free Survival Among Women With Stage I Endometrial Cancer: A Randomized Clinical Trial LACE

Disease site

Uterine 

Publication month/year

March 2017

Study question

To investigate whether total laparoscopic hysterectomy is equivalent to total abdominal hysterectomy in women with treatment naive apparent stage 1 endometrial cancer regarding disease free survival

Type of study

Randomised controlled trial (RCT)

Interventions compared

Total laparoscopic hysterectomy vs. total abdominal hysterectomy – surgical approaches to hysterectomy, bilateral salpingo-oophorectomy +/- pelvic/para-aortic lymphadenectomy

Experimental arm (Intervention)

Total laparoscopic hysterectomy +/- lymphadenectomy

Control arm

Total abdominal hysterectomy +/- lymphadenectomy

Primary outcome

Disease free survival in stage 1 endometrial cancer defined as date of surgery to date of first recurrence interval including disease progression, new primary cancer or death assessed at 4.5 years after randomisation

Secondary outcomes
  • Endometrial cancer recurrence (histologically confirmed if feasible)
  • Overall survival
  • Patterns of recurrence
  • Morbidity
  • Pain/analgesia use
  • Quality of life
  • Cost effectiveness
Inclusion criteria
  • Histologically confirmed endometrioid adenocarcinoma of the endometrium
  • any grade (as per FIGO staging system)
  • No evidence of extra-uterine disease determined by imaging (MRI/CT abdomen/pelvis and Chest X-Ray/CT chest)
Exclusion criteria
  • Histological cell type not endometrioid on curettage
  • FIGO Stage 2+
  • Bulky lymph nodes on imaging
  • Uterus size of more than 10 weeks gestation
Results
Laparoscopy Laparotomy
Randomised(n) 407 353
Received allocated treatment(n) 356 339
Disease free survival @ 4.5 ears 81.6% 81.3%
Recurrence/new primary/death (n, %) 70(17.2) 60(17%)
Uterine cancer related death(n,%) 16(53.3%) 14(58.3%)
Overall survival 92% 92.4%
>10% improvement in QoL@4 weeks post surgery 31% 14%
Surgery time (min, median) All 130(50-300) 105(35-249)
Lymph node yield (n, median) 11(7-15) 10(5-28)
Recurrence free survival in BMI<30 77.4% 86.6%
Recurrence free survival in BMI>30 84.4% 78.9%
  • Cases balanced across both treatment arms regarding stage, grade, type, number of positive nodes, metastases, adjuvant treatment provision, stratification and other baseline factor
  • No statistical significance in rate of recurrence or primary site of recurrence of endometrial cancer between the two groups
Conclusions

Total laparoscopic hysterectomy vs. total abdominal hysterectomy results have similar disease free survival with no difference in overall survival in the management of stage 1 endometrial cancer

Study limitations
  • Adjuvant treatment recommended as per local clinical practice guidelines
  • Variation in surgical technique and potential inconsistent application of pelvic/para-aortic retroperitoneal lymph node dissection
  • Not possible to blind patients/surgeons however this was unlikely to affect disease free/overall survival
  • Lymphadenectomy rates lower in cases of total laparoscopic hysterectomy
  • Suggested statistical artifact regarding increased disease free survival for cases of total laparoscopic hysterectomy in patients with BMI≥30
  • Variation in opinion regarding need for comprehensive surgical staging and lymphadenectomy in cases of early stage endometrial cancer
Additional resources
Reviewer name