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An open surgical approach is preferable to minimally invasive surgery for early-stage cervical cancer and should be considered the standard of care, new data confirm.

The current standard surgical approach for International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IA2 to IB2 cervical cancer is open radical hysterectomy and lymph node staging.

Pedro Ramirez, MD, of Houston Methodist Hospital, and colleagues reported the final results of the prospective, noninferiority randomized Laparoscopic Approach to Cervical Cancer (LACC) trial of open versus minimally invasive radical hysterectomy. "Given the higher recurrence rate and worse overall survival with minimally invasive surgery, an open approach should be standard of care," the team concluded in the .

In the following interview, Ramirez, who is chair of the Department of Obstetrics & Gynecology, discusses the findings.

What does this article add to the literature?

Ramirez: The LACC trial was an international, open-label, randomized, non-inferiority trial that tested the hypothesis that for patients with FIGO 2009 stage IA1 (with lymphovascular invasion) through IB1 squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix, minimally invasive radical hysterectomy is not inferior to open radical hysterectomy in terms of disease-free survival (DFS).

Specifically, the study was designed to test the hypothesis that DFS at 4.5 years among women assigned to minimally invasive radical hysterectomy would be no more than 7.2 percentage points worse than that of women assigned to open surgery.

The study opened in 2008, with the goal of enrolling 740 patients, and recruited patients from 33 centers in 24 countries. The , and this was the first prospective, randomized trial exploring the comparison of oncological outcomes between open versus minimally invasive surgery in patients with early-stage cervical cancer undergoing radical hysterectomy.

The study showed that minimally invasive radical hysterectomy was associated with four times worse DFS when compared with the open approach.

What are the highlights of the study?

Ramirez: A total of 631 patients were enrolled: 319 patients were assigned to minimally invasive and 312 to open surgery. Of these, 289 patients (90.6%) underwent minimally invasive surgery and 274 (87.8%) had open surgery.

At 4.5 years, DFS was 85% in the minimally invasive group and 96% in the open group. Minimally invasive surgery was associated with a lower rate of DFS compared with open surgery. The overall survival (OS) rate at 4.5 years was 90.6% versus 96.2% for the minimally invasive and open surgery groups, respectively.

Given the higher recurrence rate and worse OS with minimally invasive surgery, an open approach is recommended as the standard of care. In addition to demonstrating inferior survival among women assigned to minimally invasive surgery, the LACC study also found that the approach was not associated with a reduction in intraoperative or postoperative adverse events.

In addition, we gathered the first prospective evaluation of quality of life, which showed that postoperative quality of life was similar between the treatment groups.

How do the results compare with other reports in the literature?

Ramirez: The results of this study are quite different from those in the previous literature. Up until the time of publication of the LACC trial, the retrospective literature had shown that the minimally invasive radical hysterectomy was associated with lower rates of intraoperative blood loss, lower postoperative complications, shorter length of stay, and faster return to normal daily activities.

One of the very important items to highlight here is the fact that the majority of the retrospective data had focused on perioperative outcomes rather than on oncologic outcomes. To that end, not much emphasis had been placed on looking at whether the minimally invasive approach was associated with worse oncologic outcomes than the traditional open approach.

Many of the retrospective studies had widespread methodologic limitations, including small sample size, use of historical controls, and lack of adjustment for confounders. These methodologic deficiencies contributed to a biased appraisal of the oncologic efficacy of minimally invasive surgery.

For which early-stage cervical cancer patients would minimally invasive surgery be appropriate?

Ramirez: Currently, this is one of the most debated topics of discussion in the field of gynecological oncology. We are still debating the reason for our unexpected findings. The most likely reason for the worse findings in minimally invasive radical hysterectomy is the contamination of the abdominal and pelvic cavity by gross disease when using a uterine manipulator.

In addition, the pneumoperitoneum may also play a role in the implantation of cancer cells throughout the peritoneum as the tumor is being manipulated during surgery.

Retrospective data have shown that by performing a vaginal protective maneuver (thus avoiding tumor spillage), one could potentially see similar results as an open procedure while still benefiting from minimally invasive surgery.

Given recent data, there seems to be a patient population who are considered low risk who may benefit from minimally invasive surgery. This is generally for patients who have microscopic disease which has been removed and confirmed to have negative surgical margins. However, there have been no prospective, randomized trials to show that minimally invasive surgery is safe in that setting.

What is your main message for practicing oncologists?

Ramirez: The most important message is to follow the recommendations of the NCCN [National Comprehensive Cancer Network] guidelines, which support the use of open surgery when performing radical hysterectomy in the setting of early-stage cervical cancer.

The only setting where patients with early-stage disease should be undergoing minimally invasive surgery is in clinical trials.

Read the study here and expert commentary about it here.