Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer

BACKGROUND

There are limited data from retrospective studies regarding whether survival outcomes after laparoscopic or robot-assisted radical hysterectomy (minimally invasive surgery) are equivalent to those after open abdominal radical hysterectomy (open surgery) among women with early-stage cervical cancer.

METHODS

In this trial involving patients with stage IA1 (lymphovascular invasion), IA2, or IB1 cervical cancer and a histologic subtype of squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, we randomly assigned patients to undergo minimally invasive surgery or open surgery. The primary outcome was the rate of disease-free survival at 4.5 years, with noninferiority 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

A total of 319 patients were assigned to minimally invasive surgery and 312 to open surgery. Of the patients who were assigned to and underwent minimally invasive surgery, 84.4% underwent laparoscopy and 15.6% robot-assisted surgery. Overall, the mean age of the patients was 46.0 years. Most patients (91.9%) had stage IB1 disease. The two groups were similar with respect to 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 rate of disease-free survival at 4.5 years was 86.0% with minimally invasive surgery and 96.5% with open surgery, a difference of −10.6 percentage points (95% confidence interval [CI], −16.4 to −4.7). Minimally invasive surgery was associated with a lower rate of disease-free survival than 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 remained 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).

CONCLUSIONS

In this trial, minimally invasive radical hysterectomy was associated with lower rates of disease-free survival and overall survival than open abdominal radical hysterectomy among women with early-stage cervical cancer. (Funded by the University of Texas M.D. Anderson Cancer Center and Medtronic; LACC ClinicalTrials.gov number, NCT00614211.)


Radical hysterectomy with pelvic lymphadenectomy remains the standard recommendation for patients with early-stage cervical cancer. Current guidelines from the National Comprehensive Cancer Network and European Society of Gynaecological Oncology indicate that either laparotomy (open surgery) or laparoscopy (minimally invasive surgery performed with either conventional or robotic techniques) is an acceptable approach to radical hysterectomy in patients with early-stage (IA2 to IIA) cervical cancer.1,2 These recommendations have led to widespread use of a minimally invasive approach for radical hysterectomy, although there is a paucity of adequately powered, prospective, randomized trials evaluating survival outcomes.3-6

Retrospective studies involving patients with early-stage cervical cancer have shown that laparoscopic radical hysterectomy is associated with less intraoperative blood loss, a shorter length of hospital stay, and a lower risk of postoperative complications than open abdominal radical hysterectomy.7-9 Similarly, the minimally invasive approach has not been associated with lower 5-year rates of disease-free survival or overall survival than the open approach.10-12A recent meta-analysis showed that robot-assisted radical hysterectomy was associated with better perioperative outcomes than the open approach.13 In addition, retrospective studies have shown that recurrence rates and survival rates do not differ significantly between the two approaches.14-16

 

We hypothesized that minimally invasive radical hysterectomy was not inferior to open radical hysterectomy in terms of the disease-free survival rate. In the present trial, the Laparoscopic Approach to Cervical Cancer (LACC) Trial, we tested this hypothesis by prospectively assigning patients to minimally invasive (conventional laparoscopic or robotic) or open abdominal radical hysterectomy and comparing the disease-free survival rate, the rate of recurrence, and the overall survival rate between the two groups.


Methods


TRIAL DESIGN

The trial was a phase 3, multicenter, randomized trial with the primary objective to evaluate the hypothesis that laparoscopic or robot-assisted radical hysterectomy (minimally invasive surgery) was not inferior to open abdominal radical hysterectomy (open surgery) with respect to the percentage of patients who were disease-free at 4.5 years after surgery. Secondary objectives included comparing the two groups with regard to recurrence rates and the overall survival rate. The trial design and characteristics of the patients have been published previously,<span style="margin: 0px; p

Comments

  • NoTimeForCancer
    NoTimeForCancer Member Posts: 3,353 Member
    The above study was known as

    The above study was known as the LACC Trial, Laparoscopic Approach to Cervical Cancer.  

    As scary as it is finding that you have cancer, be sure to ask your gynecologic oncologist (and that is the specialist you want to work with) if they know about the LACC Trial.  Be your own advocate. 

    I am a visitor from the Uterine board who wants to support all gyn cancers.  I got lucky that I had great doctors when I was diagnosed, but not everyone is.  

  • ChessieMae
    ChessieMae Member Posts: 7 Member
    edited April 2020 #3
    Glad to See this Posted

    Before my visit to the surgeon I had read about this and was concerned for robotic surgery.  I was not able to get a biopsy before to make sure I even had cancer. Dr. Wanted to do the robotic surgery but I refused.  Dr.  finally agreed to open surgery.  Am happy I did read about this and get the open surgery as it turned out I had serous cancer in uterus that would have been spread all over.  As it was the cancer was contained in uterus.  No cancer found in lymph nodes.  Really pays to read and research.  Did adjuvant therapy of 6 chemo and 4 brachytherapy.  

  • cmb
    cmb Member Posts: 1,001 Member

    Glad to See this Posted

    Before my visit to the surgeon I had read about this and was concerned for robotic surgery.  I was not able to get a biopsy before to make sure I even had cancer. Dr. Wanted to do the robotic surgery but I refused.  Dr.  finally agreed to open surgery.  Am happy I did read about this and get the open surgery as it turned out I had serous cancer in uterus that would have been spread all over.  As it was the cancer was contained in uterus.  No cancer found in lymph nodes.  Really pays to read and research.  Did adjuvant therapy of 6 chemo and 4 brachytherapy.  

    Congrats

    Congratulations on finishing your treatment. I hope you are doing well now. But should you have further questions about your uterine cancer, I'd like to suggest that you post them on the uterine board (https://csn.cancer.org/forum/189). The ladies there will be happy to share their experiences with you if issues pop up in the future.