Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer
- Study type
- Clinical trial
- Study name
- LACC
- Phase
- Phase 3
- Design
- International randomised non-inferiority trial
- Sample size
- 631 patients
- Source
- N Engl J Med · 2018
- Trial registration
- NCT00614211
In plain words
This study showed that in radical surgery for cervical cancer, the “open” approach (a cut in the abdomen) gives better results than laparoscopic or robotic surgery: the cancer came back and patients died more often with the minimally invasive (keyhole) approach. This is why open surgery is usually recommended for this operation today, even if recovery takes a little longer.
Key results
Treatment arms and regimens
Laparoscopic (84.4%) or robot-assisted (15.6%) radical hysterectomy. This is a surgical intervention with no drug dose.
Open abdominal radical hysterectomy.
Source of the regimen details: Surgical intervention; no drug doses. Surgical complications from the LACC secondary analysis (Am J Obstet Gynecol 2020; PMC7181470)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Women with stage IA1 (with lymphovascular invasion), IA2 or IB1 cervical cancer with squamous, adenocarcinoma or adenosquamous histology; mean age 46.0 years; 91.9% stage IB1.
Endpoints
Primary endpoint: rate of disease-free survival at 4.5 years (non-inferiority if the lower limit of the 95% confidence interval of the difference was greater than −7.2 percentage points). Secondary: overall survival and pattern of recurrence.
Safety and side effects
The main outcome of this study was survival. In a secondary analysis of complications (536 patients eligible for analysis; Obermair et al., 2020): intraoperative complications of grade 2 or higher in 12% with minimally invasive surgery versus 10% with open surgery (P=0.45), and postoperative complications of grade 2 or higher within 6 months in 54% versus 48% (P=0.14); overall, 16.9% of patients had grade 3 or higher complications and 12.8% had serious complications.
Clinical significance and place in guidelines
LACC changed the surgical standard. The ESGO/ESTRO/ESP 2023 guideline considers open surgery (laparotomy) the standard approach for all surgery involving radical parametrectomy [I, A], and considers a minimally invasive approach only for low-risk tumours (less than 2 cm with clear margins after conisation) in high-volume centres and with the patient's informed consent [IV, C].
Limitations
Enrolment was stopped before the planned sample size was reached; the number of events was small; the surgeons' experience with the minimally invasive approach and the small share of robotic surgery have been debated; the exact cause of the difference (such as the use of a uterine manipulator or tumour cell spillage) is unclear.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.