1. This randomized controlled trial of women with early-stage cervical cancer reports that patients who underwent minimally invasive radical hysterectomy had lower rates of overall survival and disease-free survival at 4.5 years compared to women who underwent abdominal radical hysterectomy.
2. Women randomized to the minimally invasive group also appeared to have higher rates of local cervical cancer recurrence compared to the open surgery group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Early cervical cancer is currently most commonly treated with radical hysterectomy. While most surgeries had traditionally been performed through open laparotomy, minimally invasive options are now considered as a standard alternative surgical approach as they are generally associated with lower risks of infection and faster recovery times compared to open surgery. To date, long term outcomes of minimally invasive surgery versus open surgery have mainly been studied in retrospective fashion and as a result there is limited data on prospective survival outcomes. In this current analysis, the Laparoscopic Approach to Cervical Cancer (LACC) trial randomized women with early stage cervical cancer to undergo either a minimally invasive surgical approach (laparoscopic or robotic radical hysterectomy) versus open radical hysterectomy, hypothesizing that minimally invasive techniques are non-inferior to open surgical methods based on disease-free survival, overall-survival and cancer recurrence rates. Overall, researchers found that minimally invasive radical hysterectomies were associated with lower disease-free and overall survival rates at 4.5 years compared to open abdominal surgery. In addition, minimally invasive surgeries in this population were also associated with higher rates of local cervical cancer recurrence.
Together these results challenge previous literature reporting no survival difference between minimally invasive or open surgery routes for cervical cancer. Strengths of this study include its randomized design, per-protocol and intention-to-treat analysis, and length of follow-up. Limitations were inclusion of most patients in one oncologic stage and limited secondary outcomes assessed.
In-Depth [randomized controlled trial]: This phase three, multicenter, randomized controlled trial enrolled 631 patients with either stage IA1, IA2 or IB1 squamous-cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix. Patients were randomly assigned to undergo minimally invasive surgery (n=319) or open laparotomy (n=312). Enrollment for this study took place from June 2008 to June 2017. The primary outcome of this analysis was to evaluate for non-inferiority of minimally invasive surgical methods to treat cervical cancer compared to abdominal radical hysterectomy, based on the percent of patients who were disease-free 4.5 years after surgery. Secondary outcomes included cancer recurrence rates and overall survival rates at the end of the study period. Of note, study enrollment ended early as safety monitoring committees found that the minimally invasive surgical intervention group had higher rates of death by June 2017 as compared to the abdominal hysterectomy group. Baseline characteristics were balanced between groups, and most patients in the cohort had stage IB1 disease (582/631 patients; 91.9%). No significant differences were noted between groups when comparing postsurgical tumor grade (21.0% of the minimally invasive group and 21.6% of the abdominal group had a tumor grade of III), lymphovascular invasion (24.1% in the minimally invasive group, 28.7% in the open group), parametrial involvement (6.5% in the minimally invasive group, 3.9% in the open group) or lymph-node involvement (12.4% in the minimally invasive group, 13.1% in the open group). The minimally invasive group had a 4.5 year disease free survival rate of 86.0%, compared to 96.5% in the open surgery group (-10.6 point difference; 95% confidence interval [CI], -16.4 to -4.7; P=0.87 for non-inferiority). The minimally invasive group also had a lower 3 year disease-free survival rate (91.2% vs 97.1%; hazard ratio [HR], 3.74; 95% CI, 1.63 to 8.58), lower 3-year overall survival rate (93.8% vs 99.0%; HR, 6.0; 95% CI, 1.77 to 20.30), higher 3-year death rate from cervical cancer (4.4% vs 0.6%; HR, 6.56; 95% CI, 1.48 to 29.00), and a higher 3-year rate of regional recurrence (3-year recurrence-free survival rates 94.3% vs 98.3%; HR, 4.26; 95% CI, 1.44 to 12.60).
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