June 23, 2023
4 min read
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Disclosures: Bixel reports no relevant financial disclosures.
Researchers at The Ohio State University have launched an international clinical trial that will compare minimally invasive robotic surgery with open surgery for women undergoing radical hysterectomy for cervical cancer.
The study will revisit the question of which option is better in light of the 2018 Laparoscopic Approach to Cervical Cancer (LACC) trial, which raised concerns about increased risk for mortality and cancer recurrence among women undergoing minimally invasive surgery. The findings of that study, which closed early due to concerns about patient harm, have led to a decrease in use of minimally invasive surgery for early-stage cervical cancer.
“We have used minimally invasive techniques for many different types of surgery, and we know there are significant benefits to our patients: much shorter hospital stay, less intraoperative blood loss, lower rates of postoperative complications and faster recovery,” Kristin L. Bixel, MD, gynecologic oncologist at The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, told Healio. “So, when the LACC study was published that really hit us all, because we have been pushing to move things in a less invasive direction.”
Bixel spoke with Healio about the status of the study, what she hopes to learn from it, and the crucial adjustment she made to the minimally invasive approach to ensure patient safety.
Healio: What prompted this investigation?
Bixel: The LACC trial showed evidence that minimally invasive surgery in this patient population is potentially harming patients and creating worse cancer outcomes. I immediately thought, “Why is this happening?” In my opinion, there is very clearly something we are doing differently at the time of that surgery. When you look at the specimens that come out, they look very similar, but when you think about the techniques we are using, they are very different. So, knowing we had all these benefits to minimally invasive surgery and recognizing that we were doing these surgeries differently, I thought if we could address those differences, we could potentially afford our patients the benefits of minimally invasive surgery and improve their outcomes or achieve similar outcomes.
Healio: What will you do differently in performing the minimally invasive procedures in your study?
Bixel: I felt passionate about the fact that we couldn’t repeat this study without a clear change in the procedure that could potentially benefit patients. So, we started thinking again about these differences.
When you perform this surgery in an open fashion, you remove the same structures: uterus, cervix, fallopian tubes, and the tissue beside the cervix and the upper vagina. You put a clamp below the tumor to access the vagina, and then you cut below so that you’re dividing the vagina. However, the tumor is always protected — it is never exposed to the abdominal cavity or the peritoneal cavity.
In a minimally invasive procedure, that step was previously often skipped. The vagina was divided without this covering or protecting of the tumor. So, in theory, this tumor is exposed to the abdominal cavity. Circulating gas could potentially circulate tumor cells. Increased pressure could possibly increase the chance that those cells implant or take hold in new places. We don’t have a randomized trial showing that happened, but in theory it seems very reasonable that could be the case.
Retrospective studies have looked at patients who had tumor containment before minimally invasive surgery. Interestingly, their outcomes seemed very, very similar to those of the patients who had open surgery.
Again, these were retrospective studies. They’re hypothesis-generating and support the concept that if we modify the techniques, the outcomes could be the same between the open and the minimally invasive procedure. We drew from this retrospective data and hypothesized that changing the surgical procedure would improve outcomes. We used this hypothesis to create the protocol. The participants are randomly assigned to surgery with an open technique or with a standard robotic technique, but with tumor containment
Healio: Where does the study currently stand?
Bixel: Our study is underway. It is being conducted through the Gynecologic Oncology Group. It is funded with an unrestricted research grant from Intuitive Foundation, which makes the Da Vinci robot. That funding is unrestricted. Intuitive has no say in how the study is designed or performed but felt this was an important enough question to warrant investigation.
I worked with my co-principal investigator, Mario M, Leitao, MD, from Memorial Sloan Kettering Cancer Center. We are still opening at various sites, with a target of 80 sites. We plan to enroll a total of 840 patients. We’re meeting frequently with a safety advisory board that reviews all the data to ensure we don’t have any early signals that the response or recurrence rates could be higher in the minimally invasive arm, or that it could be harming patients.
Healio: What could be the implications of this study? Could it lead to more frequent use of minimally invasive surgery in this population?
Bixel: Yes. It would effectively make minimally invasive surgery part of the standard of care. Minimally invasive surgery was previously endorsed by national committees and national guidelines, but we didn’t have any data to show whether it was equivalent or not. If our study shows that the outcomes are similar with a minimally invasive technique, I am sure it will absolutely become standard of care. Prior to publication of the LACC trial, more than 50% of radical hysterectomies were performed using robotic or laparoscopic techniques. So, I think it would be rapidly reintroduced.
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For more information:
Kristin L. Bixel, MD, can be reached at kristin.bixel@osumc.edu; Twitter: @kbixelMD.
Trial to take new look at minimally invasive vs. open surgery for early cervical cancer - Healio
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