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November 2, 2018

'None of us expected this': New research warns against minimally invasive cervical cancer surgery

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    Read Advisory Board's take: How cancer programs—of all sizes—should respond

    Minimally invasive surgery for cervical cancer is more likely to lead to cancer recurrence and death than open abdominal surgery, according to new research published Wednesday in the New England Journal of Medicine.

    The results, which have been circulating among cancer specialists, are already prompting changes at cancer practices, according to the New York Times.

    What is minimally invasive surgery?

    To perform minimally invasive laparoscopic surgery for cervical cancer, a surgeon makes three to four small incisions in the patient's abdomen in order to insert the tools required to remove the uterus through the vagina. Surgeons have used the minimally invasive approach since around 2006.

    Previous research had shown the minimally invasive approach was as effective as open surgery for treating uterine cancer. However, while uterine cancer surgery involves a "simple" hysterectomy—removal of the uterus—cervical cancer requires a "radical" hysterectomy, which involves removal of the uterus as well as part of the vagina and surrounding tissue.

    Death rate higher with minimally invasive surgery, researchers find

    To better understand the differences in outcomes between open and minimally invasive surgery, MD Anderson Cancer Center and Medtronic—which makes the devices used in minimally invasive surgery—funded a clinical trial. The trial recruited 631 patients across 33 hospitals from June 2008 through June 2017. The average age was 46. All participants had early-stage cervical cancer, as surgery is not used to treat advanced cases. Patients were randomly assigned to have open or laparoscopic surgery.

    An independent review board monitored the trial to ensure patient safety.

    While the trial was still underway, the review board recommended the trial temporarily halt enrollment because the panel had observed a higher number of deaths in the minimally invasive group. Further analysis confirmed the high death rate, and researchers halted the trial, which was originally intended to include 740 patients.

    The researchers found that after 4.5 years 96.5% of patients who had open surgery were cancer-free, compared with 86% patients who had minimally invasive surgery. Among patients who received minimally invasive surgery, 14 patients died from cancer, compared with two patients who received open surgery.

    The researchers did not identify a reason for the differences in outcomes but provided several theories. One is that the instrument that passes through the cervix in some minimally invasive procedures might spread cancer cells. Researchers also suggested that carbon dioxide, which his used to inflate the abdomen during minimally invasive surgeries, might help cancer cells invade tissue. Another theory is that the minimally invasive surgery does not remove all cancerous tissue.

    A separate analysis of 2,461 cervical cancer patients found that after four years, 9.1% who had minimally invasive surgery had died, versus 5.3% of those who had open surgery.

    'That is quite a big deal'

    Jason Wright, an author of the retrospective analysis and the chief of gynecologic oncology at NewYork-Presbyterian/Columbia University Irving Medical Center, said, "None of us expected this." He added, "We expected to find [minimally invasive surgery] was as safe."

    Lee-may Chen, director of the gynecologic oncology division of the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco, said, "This turns us on our heads a bit." She added, "We thought laparoscopic surgery would be good for this patient population."

    Masha Kocherginsky, an epidemiologist at Northwestern University's Feinberg School of Medicine and co-author of the retrospective analysis, said, "That is quite a big deal." She explained, "These patients are early stage cancer patients, and the intent of surgical treatment is cure."

    Cancer specialists change practice

    News of the results has spread quickly in the medical community, and national guidelines are changing to reflect the new information about risks and benefits of the two procedures, according to NPR's "All Things Considered."

    Emma Barber, of Northwestern, tells her patients about the risks associated with each of the two choices. "I think increasingly [the choice] is going to be open surgery for many women," Barber said, adding, "but there may still be a role for minimally invasive surgery in some patients."

    Ramirez said patients should discuss the type of surgery with their doctor and "question the approach of having minimally invasive surgery if that is what is suggested to them."

    MD Anderson, according to Ramirez, has "completely stopped performing minimally invasive surgery for cervical cancer." Johns Hopkins has stopped doing the procedure and returned to open surgery "for the time being," according to Amanda Fader, director of the Kelly Gynecologic-Oncology Service at Hopkins.

    Ginger Gardner, a gynecologic oncologist at Memorial Sloan Kettering Cancer Center in New York, said Kettering was examining its own surgical results and discussing the findings with patients. Gardner said they were making decisions on a case-by-case basis (Grady, New York Times, 10/31; Harris, "All Things Considered," NPR, 10/31; Emery, Reuters, 10/31).

    Advisory Board's take

    Deirdre Saulet, Practice Manager, Oncology Roundtable

    Despite representing a relatively small number of total cancer cases, gynecologic cancers—including cervical, ovarian, uterine, and vaginal cancers—are a critical area of focus for organizations striving to provide comprehensive women's health services. However, they can be complex to treat and the research in this area is still evolving, as evidenced by this most recent study.

    “The most important element to providing high-quality gynecologic oncology care is subspecialist expertise”

    Undoubtedly, the most important element to providing high-quality gynecologic oncology care is subspecialist expertise. However, gynecologic oncologists are in short supply. And, depending on market demand and projected volumes, not every organization should invest in hiring a full-time gynecologic oncologist. Here are three strategies to ensure access to expertise based on an organization's gynecologic cancer volumes:

    1. High volumes: These organizations need to ramp up recruitment efforts, including building relationships with health and professional associations and investing in a pipeline of providers. One institution we worked with hires physicians out of the hospital's gynecologic oncology fellowship program. They sign long-term contracts with board-eligible gynecologic oncologists who agree to remain after attaining board certification. This helps defray administrative costs of operating the fellowship program, build referral network for the fellow, and lessen the challenges associated with recruiting a qualified physician.

    2. Medium volumes: Organizations that see some gynecologic cancers, but not enough to support a full-time provider, should explore ways to partner with other organizations to ensure access. For example, Asante Health System in Oregon leases subspecialist expertise from a regional academic center. The gynecologic oncologist travels onsite three days a month, during which she sees about 25 patients in the clinic. The cancer center also has an onsite medical assistant dedicated to helping her triage patient concerns.

    3. Low volumes: Hospitals and health systems seeing few gynecologic cancer patients should find innovative ways to make sure patients can readily be connected to and access gynecologic oncologists. For example, UVA Health System works with its community partners in two ways. First, they offer high-risk monthly clinics for virtual colposcopies in which a local NP performs the procedure while a gynecologic oncologist directs it via camera to ensure a high-quality biopsy. Second, they have been working to set up telemedicine consults in which community gynecologists meeting with patients will coordinate with UVA gynecologic oncologists to jointly discuss options. Patients may go to UVA for the consult and surgery, or the gynecologic oncologist may travel to the patient's community to perform the surgery and coordinate post-op care with local physicians.

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