New- TLH vs TAH on Disease-Free Survival Stage 1 Endometrial Ca RCT

Question 1

Effect of TLH vs TAH on Disease-Free Survival Among Women with Stage 1 Endometrial Cancer: A Randomised Clinical Trial
- author, study type, N

Answer 1

Janda et al 2017
JAMA
N 760
RCT

Aim: TLH is equivalent to TAH in women with treatment-naïve endometrial cancer

Multinational, 20 tertiary gynaeonc centres ANZ
2005-2010
TAH 353, TLH 407
89% patients completed trial

Question 2

Study design, outcome: TLH vs TAH on Disease-Free Survival Stage 1 Endometrial Ca RCT

Answer 2

Primary outcome
Disease-free survival ( interval between surgery and date of 1st recurrence, incl. disease progression or development of new primary Ca or death
followed up until 4.5 years post

Secondary outcome: recurrence of endometrial Ca and overall survival

Inclusion: grade 1 endometrial Ca

Exclusion:
Histological cell type other than endometroid
Clinically advanced disease (Stage II – IV or bulky LN on imaging
Uterus size > 10 weeks’ gestation

Question 3

Results: TLH vs TAH on Disease-Free Survival Stage 1 Endometrial Ca RCT

Answer 3

Primary outcome: Equivalent disease free survival at 4.5 years follow up

• TLH 81.6%
• TAH 81.3%

Secondary outcome:
Recurrence of endometrial Ca: NO significant difference
Overall survival: NO significant difference

Subgroup analyses
TAH: Patients with lower BMI (<30) had higher disease-free survival (86.6% vs 77.4%)
TLH: Patients with higher BMI (>30) had higher disease-free survival

Low conversion rate from TLH to TAH

Question 4

Limitations: TLH vs TAH on Disease-Free Survival Stage 1 Endometrial Ca RCT

Answer 4

Blinding between patients and surgeons not possible
Randomisation performed prior to patient scheduled for surgery
Performance of pelvic +/- paraaortic LN dissection is left to surgeons  inconsistent application