Ramirez PT, et al. - In this trial, the Laparoscopic Approach to Cervical Cancer (LACC) Trial, researchers tested their premise that inferior results were not seen with minimally invasive radical hysterectomy vs open abdominal radical hysterectomy, in terms of disease-free survival rate. For this purpose, they prospectively allocated patients to either minimally invasive (conventional laparoscopic or robotic) or open abdominal radical hysterectomy and then assessed the disease-free survival rate, the rate of recurrence, and the overall survival rate between the two groups. Researchers concluded that lower rates of disease-free survival and overall survival were evident in relation to minimally invasive radical hysterectomy vs open abdominal radical hysterectomy, in women with early-stage cervical cancer.

Methods

• In this trial, researchers randomized patients with stage IA1 (lymphovascular invasion), IA2, or IB1 cervical cancer and a histologic subtype of squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma to undergo minimally invasive surgery or open surgery.
• The rate of disease-free survival at 4.5 years was assessed as the primary outcome; noninferiority was claimed if the lower boundary of the two-sided 95% confidence interval of the between-group difference (minimally invasive surgery minus open surgery) was greater than −7.2 percentage points (i.e., closer to zero).

Results

• Researchers assigned 319 patients to minimally invasive surgery and 312 to open surgery; the patients' mean age was 46.0 years and stage IB1 disease was identified in most patients (91.9%).
• Among patients who were assigned to and underwent minimally invasive surgery, laparoscopy was performed on 84.4% and robot-assisted surgery on 15.6%.
• Regarding the histologic subtypes, the rate of lymphovascular invasion, rates of parametrial and lymph-node involvement, tumor size, tumor grade, and the rate of use of adjuvant therapy, the two groups were similar.
• With minimally invasive surgery and with open surgery, the rate of disease-free survival at 4.5 years was 86.0% and 96.5%, respectively, a difference of −10.6 percentage points (95% confidence interval [CI], −16.4 to −4.7).
• A lower rate of disease-free survival was noted in association with minimally invasive surgery vs open surgery (3-year rate, 91.2% vs 97.1%; hazard ratio for disease recurrence or death from cervical cancer, 3.74; 95% CI, 1.63 to 8.58), a difference that was sustained after adjustment for age, body-mass index, stage of disease, lymphovascular invasion, and lymph-node involvement; minimally invasive surgery was also associated with a lower rate of overall survival (3-year rate, 93.8% vs 99.0%; hazard ratio for death from any cause, 6.00; 95% CI, 1.77 to 20.30).