LACC Study

Disease site

Cervix

Publication month/year

November 2018

Study question

Is minimally invasive radical Hysterectomy inferior to open radical hysterectomy in terms of disease free survival rate for early stage cervical cancer?

Type of study

Randomised controlled trial (RCT)

Interventions compared

Minimally Invasive Approach (Laparascopic or Robotic) Vs Open in Abdominal Radical Hysterectomy

Experimental arm (Intervention)

Minimally invasive Surgery

Control arm

Open surgery

Primary outcome

Overall survival (OS)

Secondary outcome
  • Recurrence Free Survival (RFS)
  • QoL
Inclusion criteria
  • Histopath: Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma.
  • Disease stage of 1A1 (LVSI +ve); 1A2 (stromal invasion, 3-5mm deep and <7mm wide); or, 1B1 (tumour <4cm and no node involvement).
  • Underwent type II or III radical hysterectomy (Piver classification)
  • Had ECOG performance status score of 0 or 1
Exclusion criteria
  • Uterine size >12cm
  • History of abdominal/pelvic radiotherapy
  • Evidence of metastatic disease on PET/MRI/CT
  • Unable to withstand surgery / lithotomy positioning + steep trendelenberg.
Results
MIS Open
Randomised(n) 312 319
Received treatment(n) 289 274
Adjuvant treatment(n,%) 92(28.8%) 86(27.6%)
Disease recurrence or Death from any cause(n,%) 32(10%) 8(2.6%)
Locoregional recurrence(n,%) 18(4.6%) 4(1.3%)
Death from any cause(n,%) 19(6%) 3(1%)
Death from cervical cancer(n,%) 14(4.4%) 2(0.6%)
Disease free survival@4.5ys (%) 86% 96.5%
  • The rate of DFS at 4.5 years was 86% in minimally invasive surgery and 96.5% with open surgery. A difference of -10.6 percentage points.
  • Minimally invasive surgery had lower rate of DFS than open (3-year rate, 91.2% Vs 97.1%; HR for disease recurrence or death from cervical cancer 3.74; 95%CI 1.63-8.58).
  • Minimally invasive surgery associated with lower rate of OS (3-year rate, 93.8% Vs. 99%).
Conclusions
  • Minimally invasive radical hysterectomy (lap or robotic) was associated with lower rates of OS and DFS when compared to open radical hysterectomy among women with early stage cervical cancer.
Study limitations
  • Final enrolment not reached.
  • At the time of analysis only 59.7% of patients had reached the 4.5 year follow up time point (median follow-up 2.5years).
  • Trial not powered to evaluate oncologic outcomes.
  • Did not account for differences in surgical proficiency.
Additional resources

Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): a secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial: //www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30081-4/fulltext

Reviewer name

Edward Jackson