A treatment for early stage cervical cancer that has rapidly gained acceptance in the United States turns out to be worse than standard surgery, according to two studies.
The practice, now thrown into question, is called minimally invasive surgery. Instruments are threaded through small incisions, and surgeons use those to remove a diseased uterus. This technique has been growing in popularity since 2006 and has been widely adopted.
But it turns out that minimally invasive surgery for early stage cervical cancer has unexpected risks. The studies were published online Wednesday in the New England Journal of Medicine.
"Patients who underwent the minimally invasive surgery had four times greater likelihood of [cancer] recurrence than when they had the surgery through the open approach," says Dr. Pedro Ramirez at the MD Anderson Cancer Center in Houston.
That was the surprising result of a study he co-authored comparing the minimally invasive approach with standard surgery though a large incision. The study involved more than 600 women recruited at medical centers worldwide. Half had their uterus removed through open abdominal surgery; the other half had minimally invasive surgery.
A safety board overseeing the experiment called it to a halt before its scheduled completion after it became obvious that women in the minimally invasive group were doing substantially worse.
These women were also less likely to be alive 4 1/2 years following the surgery. About 94 percent of the women were still alive after minimally invasive surgery, compared with 99 percent of women who had standard surgery for the early stage cancers being studied. (Women with more advanced cervical cancer are generally treated with chemotherapy and radiation rather than surgery.)
Ramirez says surgeons at MD Anderson "decided to stop offering the minimally invasive radical hysterectomy and completely convert to the open approach."
The research team reported its preliminary results at a cancer meeting in March, and since then, Ramirez says, doctors throughout the United States have been reconsidering their approach to treating early cervical cancer.
What's causing this effect is a bit of a mystery. According to similar high-quality studies, "for uterine cancer, minimally invasive surgery is safe," Ramirez says. That suggests that cervical cancer cells may be released more readily during a procedure. Ramirez says carbon dioxide gas used to inflate the abdomen during this surgery could also be playing a role.
The study was funded in part by medical-device maker Medtronic. Ramirez said the company had no role in analyzing or publishing the results.
Making the outcome even stronger, a second study published alongside this report comes to the same conclusion about minimally invasive surgery for early cervical cancer.
For the second report, a research team headed by scientists at Northwestern University looked at national cancer data and found that after four years, 9 percent of the women with minimally invasive surgery had died, versus 5 percent of the women with open surgery.
"That is quite a big deal," says Masha Kocherginsky, an epidemiologist and co-author of the study. "These patients are early stage cancer patients, and the intent of surgical treatment is cure."
What's more, the researchers noted that the national survival trend for early cervical cancer, which had been improving for years, started to decline in 2006, just as minimally invasive surgery started becoming popular.
Word of these results has spread among physicians, and as a result the national guidelines are already changing to reflect the risks and benefits of these two approaches.
Dr. Emma Barber at Northwestern says she now tells her patients about the choice they face. "I think increasingly that's going to be open surgery for many women," she says, "but there may still be a role for minimally invasive surgery in some patients."
You can reach Richard Harris at firstname.lastname@example.org.
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Two studies out today raised concerns about a treatment for early stage cervical cancer that had gained favor in the U.S. The studies, published online in the New England Journal of Medicine, say minimally invasive surgery is actually worse for women than standard surgery. Now doctors are starting to shy away from it. NPR's Richard Harris reports.
RICHARD HARRIS, BYLINE: Early cervical cancer is often treated with surgical removal of the diseased uterus. New techniques called minimally invasive surgery started becoming popular among doctors in 2006. Dr. Pedro Ramirez at MD Anderson Cancer Center says instead of one large incision...
PEDRO RAMIREZ: It will be performed through very small incisions in the abdomen where instruments are introduced in through the abdomen through those small incisions.
HARRIS: Ramirez and his colleagues decided to compare those two approaches. Six hundred women in total volunteered for this worldwide study. Overseers stopped the study early after noticing a significant and surprising difference.
RAMIREZ: Patients who underwent the minimally invasive surgery had four times greater likelihood of returns than when they had the surgery through the open approach.
HARRIS: They were also more likely to die in the next four years. Ramirez says surgeons at MD Anderson immediately changed their treatment for early cervical cancer.
RAMIREZ: We decided to stop offering the minimally invasive radical hysterectomy and completely convert to the open approach.
HARRIS: What's causing this is a bit of a mystery. Ramirez says similar studies show that minimally invasive surgery is just as good as open surgery if a uterus is removed as a result of uterine cancer.
RAMIREZ: For uterine cancer, minimally invasive surgery is safe.
HARRIS: A second study, which analyzed national data, found the same added risk of minimally invasive surgery to treat early stage cervical cancer. Co-author Emma Barber, a physician at Northwestern University, says already national guidelines are being changed, directing doctors to discuss the benefits and risks of these two options.
EMMA BARBER: I think increasingly that's going to be open surgery for many women, but there may still be a role for a minimally invasive surgery in some patients.
HARRIS: Richard Harris, NPR News. Transcript provided by NPR, Copyright NPR.