publication date: Nov. 2, 2018

Experts: Minimally invasive procedures in gynecology gained universal acceptance before hard questions were asked

Brian Slomovitz

Brian Slomovitz

Director, Division of Gynecologic Oncology,

Department of Obstetrics and Gynecology, University of Miami, Miller School of Medicine

Co-leader, Gynecologic Cancers Site Disease Group, Sylvester Comprehensive Cancer Center

 

think these investigators should be commended in doing this trial and coming up with these results. It shows that, in a clear way, we can’t make assumptions in anything we do. The assumption that robotic surgery would be just as good as open surgery is clearly demonstrated here that it’s not a fair assumption.

In gynecologic oncology, oftentimes we follow the path of seeing that something works in a phase II setting, whether that be a drug trial or we’re seeing that optimal debulking works for ovarian cancer, and then moving forward in testing it in a prospective head-to-head setting.

That being said, phase III surgical trials are always very difficult to do, but yes, minimally invasive surgery for cervical cancer was widely accepted and embraced. These results are compelling and practice-changing in that it’s a head-to-head trial showing that the older technique was better.

When you look at the data, compared to historical controls in the MD Anderson study, it’s not that the patients who had minimally invasive surgery did worse, they did just as good as the historical controls. Patients that had open surgery, for whatever reason, did better.

It reiterates to us that we need to continue to do head-to-head trials in order to establish the standard of care. For example, was ovarian cancer debulking based on randomized trials?

No, it was based on retrospective studies that showed, patients who had optimal debulking did better than patients who didn’t have optimal debulking. We didn’t do a randomized trial to see if we debulk some patients and then debulk other patients to see who would live longer. It was based on retrospective data.

Unlike that, here, there are two approaches—minimally invasive vs. open. I would say that it’s one of the first, if the only, times that reinforces that, yes, it’s important to do these trials.

Another example in gynecologic oncology would be secondary cytoreduction surgery for ovarian cancer. We used to do it all the time, until recent study says it makes no difference and chemo alone is just as good. It’s fair to say that in cancer surgery for gynecologic malignancies, we do first, and then ask the important questions later.

I think this is another example that for us, as surgeons who care for patients that could have deadly diseases, “getting the tumor out” is not simply the answer, but how we get the tumor out and in what fashion, and whether that affects the biology and aggressiveness of the disease—we learn that here, and we learned that in morcellation for sarcoma and other uterine cancers, that it does matter.

We need to carefully evaluate the way we’re doing things and not just assume that one way is good because it’s associated with a shorter hospital stay, or it’s associated with small incisions.

I think it’s safe to say that quality of life factors and patient preference factors such as shorter hospital stay, smaller incisions, less postoperative pain—those all do play crucial roles in the management of women who have cancer.

That being said, the primary objective of these studies is survival or recurrence rates—we can’t overlook those objectives and those findings, even if robotic surgery can give you a shorter length of stay. Or, in the case of morcellation, it can give you a smaller incision.

We jump into these procedures before they are proven, and we need to remember that patient outcomes and survival come first. We have to look at ourselves carefully as a specialty that treats women and make sure that we’re moving in the right direction.

At Sylvester Comprehensive Cancer Center, we’re discussing the results with our patients, but the first choice is open surgery based on the results of the study.


Ronald Alvarez

Ronald Alvarez

Betty and Lonnie S. Burnett Professor of Obstetrics and Gynecology,

Chair, Department of Obstetrics and Gynecology, Vanderbilt University Medical Center

 

These are two important papers that use two different but methodologically sound investigative approaches to ask the question: whether radical hysterectomy for early stage cervical cancer performed by a minimally invasive approach has the same outcome when compared to radical hysterectomy performed by an open laparotomy approach.

In contrast to the results noted in prior predominantly smaller studies in early stage cervical cancer, the authors noted higher rates of recurrence when a minimally invasive approach was utilized to perform a radical hysterectomy.  

As with all good research, we are left with more questions than answers:

  • What are the reasons for the observed differences in outcomes?

  • When a minimally invasive approach is used, are the surgical margins compromised or does manipulation of the cervix or use of CO2 result in more seeding of tumor, thus increasing the risk for recurrence?

  • Would the results of these studies have been the same if restricted to patients with cervical cancers 2 cm. or less in diameter, particularly those with other low risk features?

  • Why don’t we see the same results in patients with endometrial cancer, a disease where minimally invasive surgical approaches to treatment have been widely adopted and demonstrated to have similar survival outcomes compared to when an open laparotomy approach is utilized?

Nevertheless, as clinicians, we are certainly obligated to discuss this new evidence when advising early stage cervical cancer patients, particularly those with cervical lesions that are 2.1 to 4 cm in diameter, on their surgical approach options for radical hysterectomy.


Stephen Rubin

Stephen Rubin

Chief, Division of Gynecologic Oncology,

Professor, Department of Surgical Oncology,

Paul Grotzinger and Wilbur Raab Chair in Surgical Oncology,

Fox Chase Cancer Center 

 

These are two high-quality studies: one a prospective randomized trial with excellent design and quality control, and the other a large cohort study using the National Cancer Database and a sophisticated statistical analysis. Both provided appropriate long-term oncologic follow up.

They both reached the same conclusion, that minimally invasive surgery results in significantly inferior disease-free and overall survival for women with early stage cervical cancer, compared with traditional open surgery.

These results highlight the hazards of assuming the oncologic equivalence of a new method of performing a cancer operation and adopting it widely in the absence of Level I evidence. Prior studies comparing minimally invasive and open radical hysterectomy for cervical cancer have largely been small scale retrospective studies that focused on short term surgical results such as intraoperative complications, blood loss, and duration of hospital stay, without long term cancer follow up.

Radical hysterectomy is a technically demanding operation, especially the dissection of the ureter through the paracervical tunnel, which is an essential part of achieving an appropriate oncologic margin. There are some gynecologic oncologists who have continued to prefer the open operation as they believe the tactile feedback of open surgery allows them to perform a more precise operation and attain more appropriate margins around the cervical tumor. Although the reasons for the inferior outcomes in the minimally invasive surgery patients cannot be determined from the published results, the increased incidence of pelvic recurrences may well be the result of inadequate surgical margins.

As cervical cancer is an uncommon disease in the developed world, these publications are, and are likely to remain, the definitive studies on this issue.

Taken together, these findings are practice-changing, and should prompt gynecologic oncologists to employ open surgical techniques for their patients with early cervical cancer who are candidates for radical surgery. Those of us who are involved in training the next generation of gynecologic oncologists need to ensure that our trainees are well-versed in the performance of open radical hysterectomy.

Copyright (c) 2018 The Cancer Letter Inc.