Turning a hypothesis on its head

In 2018, MD Anderson’s Gynecology Oncology and Reproductive Medicine physicians decided to change how they talked to their cervical cancer patients about surgical treatment options. They would stop touting the ease of recovery from minimally invasive radical hysterectomies and spend more time talking about the associated risk.

The charge was led by a surprising source: Pedro Ramirez, M.D., the director of Minimally Invasive Surgical Research and Education and a gynecologic oncologist who had built much of his career on embracing and teaching others how to successfully adopt minimally invasive surgery.

Ramirez had just completed a study comparing surgical techniques for radical hysterectomies, the standard of care treatment for early-stage cervical cancer patients. And to him, it was now clear that cervical cancer patients would live longer, healthier lives with lower risk of recurrence if surgeons abandoned minimally invasive radical hysterectomies and instead relied on abdominal hysterectomies, also called “open” hysterectomies.

“You have to be willing to put what you believed in aside if it means saving more patients’ lives,” Ramirez says.

Cervical cancer clinical trial yields a surprising discovery

When Ramirez and his team started the study in June 2008, they planned to include 740 patients.

But when the results were published in the New England Journal of Medicine in the fall of 2018, it only included data from 631 patients.

That’s because Ramirez received word from the data and safety monitoring committee that the study needed to close to any new patients in September 2017. An interim analysis demonstrated that one of the techniques was harming patients.

The data and safety monitoring committee met with Ramirez to share the results. Patients who had minimally invasive radical hysterectomies were four times more likely to develop a recurrence than those who had an abdominal hysterectomy. Their survival rates were lower, too.  

Ramirez was shocked. No one had expected this. The study itself had been routine, expected to conclude with no surprises.

“From then on I knew we had a responsibility to our patients. We had to give them all the information, and if necessary, change how we do surgery,” Ramirez says.

Making clinical practice changes for cervical cancer treatment

Although it hadn’t been published yet, Ramirez presented his research at the Society of Gynecologic Oncology annual meeting, one of the largest and most prestigious conferences for gynecologic oncologists. Ramirez looked at the faces of the audience members. Some sat, their mouths open in shock. Others exchanged skeptical whispers.

Not all surgeons have met the study with open arms. For some, it signifies the potential end of a technique for cervical cancer hysterectomies that they may have spent years perfecting or even built reputations and practices on.

But two other retrospective studies – one led by Alejandro Rauh-Hain, M.D., an MD Anderson gynecologic oncologist, and the other from Northwestern University –  that evaluated large national databases, echo with similar findings.

“It’s not just once, but three times, we’ve seen these results,” Ramirez says.

The rest of the Gynecologic Oncology and Reproductive Medicine faculty, Ramirez’ colleagues and leaders, knew they needed to take action in response to the study to set an example for other surgeons.

“The scientific standard is publication, not an abstract, but based on the information we had, we all felt comfortable making the change,” says Amir Jazaeri, M.D., who at the time was serving as the ad-interm chair of Gynecologic Oncology Reproductive Medicine.

Typically, the department’s faculty hold retreats twice a year to review recent studies and determine if they should make any changes to their everyday practices. This study brought change outside of the normal routine, explained Pamela Soliman, M.D., a gynecologic oncologist and director of the Gynecologic Medical Center at MD Anderson.

“Since the research was done here, we had more information and were able to make changes quickly,” Soliman says.

The data didn’t reveal why minimally invasive surgery had a higher risk of recurrence. The study wasn’t set up at the way. But the increased risk was enough to motivate change.

“A lot of questions remain unanswered, but this data signified a need for such a big change, we didn’t feel like it could wait until the retreat,” Jazaeri says.

Now Ramirez hopes the rest of the gynecologic oncology community will accept the findings, too, and make similar changes to help patients live longer without recurrence.  

“I believe acceptance is a very important part of life and medicine,” Ramirez says. “After all, challenging what we already know is exactly why we do research.”