(CNN) — A late-stage trial of women with cervical cancer at low risk of progression found that having a simple hysterectomy instead of a radical hysterectomy resulted in similar outcomes in terms of keeping them cancer-free, a finding that some doctors say could be “practice-changing.”
The results of the trial, presented Friday at the American Society of Clinical Oncology conference in Chicago, also showed that patients with the simpler surgery had fewer complications and a better quality of life.
A simple hysterectomy involves the removal of the uterus and cervix. Typically, the vagina, lymph nodes, ovaries and fallopian tubes are left in place, but they may also be removed. The surgery can be done through an incision in the abdomen or a small incision in the vagina, or it can even be done through laparoscopic surgery, in which a doctor inserts a surgical instrument through a small incision in the skin.
With a radical hysterectomy, surrounding parts of the cervix, part of the vagina and a wide area of tissues and ligaments around these organs are removed, as well as the uterus. This type of surgery is most often used to treat early-stage cervical cancer. The cure rates for the disease are around 80%, according to the National Cancer Institute, but the surgery canhave significant side effects.
Since such surgery can lead to bladder and bowel problems and reduce sexual function, doctors have speculated about whether they could do a less-radical procedure so patients could live longer but also have a better quality of life. Thanks to more effective screening, more women have been presenting with cervical cancer at a younger age and an earlier stage of the disease.
In the past couple of decades, the trend has been to do a less radical surgery in patients with low-risk cervical cancer, said study co-author Dr. Marie Plante, a professor in the Department of Obstetrics and Gynecology at Universite Laval in Quebec. Studies of retrospective data seem to suggest that a less radical surgery may be a safe option and may cause fewer problems.
In the new study, Plante and her fellow scientists funded by the Canadian Institutes of Health Research and Canadian Cancer Society did a late-stage randomized trial comparing radical hysterectomy and pelvic node dissection – removal of the lymph node from the pelvis to check whether the cancer has spread or if there is a risk that it will – against simple hysterectomy and pelvic node dissection in patients with low-risk early-stage cervical cancer. Women were randomized to receive a radical hysterectomy as a control group or a simple hysterectomy in the experimental group, and the researchers followed up for three years.
The results in the two groups were “actually quite comparable,” Plante said. The radical hysterectomy group had three times more bladder injuries, nearly twice as many urethral injuries and statistically more adverse events within about four weeks. Urinary incontinence and urinary retention were statistically worse with a radical hysterectomy. Sexual function was also better in the simple hysterectomy group, and there was less sexual pain. Surveys showed a better quality of life for patients with a simple hysterectomy.
“Simple hysterectomy can now be considered as a new standard of care for patients with low-risk early-stage cervical cancer,” Plante said.
The study is a “long-awaited advance in the field,” said Dr. Kathleen Moore, the Virginia Kerley Cade Endowed Chair in Cancer Developmental Therapeutics and professor of gynecologic oncology at the University of Oklahoma Health Sciences Center.
“This is a really big deal for women with cervical cancer,” said Moore, who wasn’t involved with the study.
If the findings lead to a change in practice for surgeons, it could “change the trajectory of cervical cancer globally,” she said.
Cervical cancer is not common in the US or Canada, Moore said, but it is endemic in low- and middle-income countries. There are 600,000 cases globally and almost 350,000 deaths from cervical cancer each year, mostly in low- and middle-income countries, the World Health Organization says.
For carefully selected patients, a simpler hysterectomy could be a better option, she said.
“This will be the new standard of care, and it represents a huge step forward in the care of women with early-stage cervical cancer, and honestly, the de-escalation may allow these women in low- and middle-income countries better access now that we understand what it does take to cure these early tumors,” Moore said. “So, this has broad implications on the global scale.”
Dr. Stephanie V. Blank, director of gynecologic oncology for the Mount Sinai Health System, also said the results have the potential to be a “big deal.”
She would like to see more follow-up beyond the three years captured in the study, but she applauds the findings.
“Survivorship is extremely important. I think it’s certainly encouraging,” said Blank, who wasn’t involved with the research.
“It’s not going to necessarily change my practice yet, but it certainly will make me consider this and maybe discuss it with patients,” she said. “It certainly has potential, and I certainly find it very encouraging.”