In a demonstration that newer isn’t always better, two studies published in the New England Journal of Medicine show that minimally invasive surgery techniques, including robotic surgery, lead to higher death rates from any cause than traditional, open surgery done through an incision in the abdomen.
Minimally invasive surgery — or keyhole surgery, in which doctors perform operations through small incisions rather than by opening up patients and exposing them to complications — and robotic surgery have shortened recovery times and cut back on infections and bleeding. So in many cases, surgeons prefer using those techniques over open surgery that often requires deeper anesthesia, longer recovery times and comes with a higher risk of infection.
That’s the case with cervical cancer; most surgeons today recommend minimally invasive hysterectomy to remove the uterus. Doctors at MD Anderson Cancer Center wanted to confirm that this was the best option for patients, so they set up a study to compare survival after the two surgical methods. Understanding how best to prevent recurrences is critical, since most cervical cancer that recurs is difficult to treat. They randomly assigned women diagnosed with early stage cervical cancer to receive either a hysterectomy via minimally invasive surgery or robot-assisted surgery, or through the traditional open technique of making an incision in the abdomen. They fully expected that there would be little difference between the two groups when it came to survival and recurrence of the cancer, which would support the shift toward minimally invasive surgery and its lower rate of complications.
But they were surprised to find that exactly the opposite was true. Before they could enroll all 740 people in the study, the study was stopped after four months because one group showed dramatically lower survival: the women assigned to receive the minimally invasive hysterectomy.
“We learned that people in the minimally invasive surgery arm had a four times higher likelihood of having a recurrence and of potentially dying than with the open surgery approach [after four to five years],” says Dr. Pedro Ramirez, director of minimally invasive surgery at MD Anderson and lead author of one of the studies.
In another study, researchers analyzed data from two large national databases that include about 70% of people diagnosed with different forms of cancer in the U.S. and compared outcomes for women with cervical cancer who received minimally invasive or open hysterectomy. There too the data was unexpected — women receiving minimally invasive surgery had a 65% higher chance of dying during the study’s four to five year follow-up than women who received open surgery.
Taken together, the results prompted doctors at MD Anderson to immediately shift from recommending minimally invasive surgery for early stage cervical cancer patients to advising women to receive open hysterectomy. Ramirez says that recovery and complication rates have improved significantly for the invasive surgery in recent years, and emerging data suggest that minimally invasive surgery may no longer necessarily be better than invasive surgery on these factors.
Ramirez first reported early results of the study at a conference last spring, and physicians have debated how it should change their treatment decisions ever since. “It’s been surprising to the community of gynecologic oncologists,” he says. “It’s been an unexpected finding for all of us.”
“I’m a huge minimally invasive surgeon, and for me it was like a dagger to the heart,” says Dr. Noah Goldman, associate professor and vice chair of clinical affairs in obstetrics, gynecology and women’s health at Rutgers, New Jersey Medical School. Goldman, who was not involved in the study but heard the results at the conference, says he favored minimally invasive surgery because of the lower complication rates and easier recovery for patients. But, he says, the final findings now published in the NEJM should spark more discussions between doctors and patients. “We’re definitely going to take a long, hard look at who we can offer the minimally invasive approach to,” he says.
It’s not entirely clear why minimally invasive surgery would lead to worse results, but Ramirez says his study can rule out one possibility: that the minimally invasive approach, in which surgeons rely on laparoscopic cameras inserted through small incisions to see what they’re doing, causes them to miss some tumors and leave them behind. In the study, there was no evidence that women who were getting the minimally invasive surgery had more residual tumors than women getting the open surgery.
Instead, likely explanations for the difference might have to do with technical features of the way minimally invasive surgery is done. It involves pumping CO2 gas — which some studies show could accelerate tumor cell growth — and it requires using a mechanical manipulator to shift the uterus and cervix, which may contaminate new tissues with tumor cells.
Theoretically, it’s possible that changing the way minimally invasive surgery is done could lead to similar survival outcomes achieved with open surgery, but to prove that’s the case, doctors would have to set up new studies that randomly assign women to getting open surgery or a new, modified minimally invasive procedure. Given the results of the current study — that the minimally invasive procedure increased the risk of recurrence or death by four times — it’s unlikely that doctors or patients would find that ethical.
Already, the National Comprehensive Cancer Network (NCCN), a non-profit alliance of 27 leading cancer centers that provides guidelines for the best way to treat cancer, now advises that women with early stage cervical cancer opt for open hysterectomy rather than minimally invasive surgery based on these latest study results.
Goldman notes, however, that there may still be some women for whom minimally invasive surgery makes sense, but new studies will have to identify those groups. The current study, for example, did not analyze which women had cancer that had spread to the lymph nodes.
For now, women with early stage cervical cancer should discuss with their doctor which treatment option is best for them. “I certainly will be more cautious, and will be talking to patients about what the data shows so that we can make the best treatment decision for them,” says Goldman.