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June 15, 2023 — A simple hysterectomy is a safe, effective treatment option for women with low-risk, early-stage cervical cancer, according to new research.
As compared to the more complex radical hysterectomy, the results were similar as far as remaining free of cancer, and women reported a better quality of life.
These results come from a large, international phase III clinical trial, which was reported at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
A simple hysterectomy involves removing the uterus and cervix. In contrast, a radical hysterectomy is more extensive and typically involves removing not only the uterus and cervix, but also the lymph nodes, upper vagina, and the tissue around the cervix.
The current standard of care for women with early-stage, low-risk cervical cancer is radical hysterectomy. But even though it has a high cure rate, the surgery can have significant side effects.
“Although radical surgery is highly effective in the treatment of low-risk disease, women are at risk of suffering survivorship issues related to long-term surgical side effects, including compromised bladder, bowel, and sexual function,” said study author Marie Plante, MD, professor in the Department of Obstetrics and Gynecology at Universite Laval in Quebec, who presented the findings at the meeting.
Because of the high risk of complications, doctors have wondered if a simpler surgery could achieve the same outcomes but with fewer side effects. Plante explained that some studies have already shown that this may be possible in a low-risk population. “Less radical surgery may be a safe option associated with decreased morbidity, in what we call surgical de-escalation,” she said.
In this study, Plante and her team randomly assigned 700 women to get either a radical hysterectomy or a simple hysterectomy. In both groups, or removal of the lymph node from the pelvis was done to see if the cancer had spread. The researchers then followed the groups for 3 years.
The researchers compared the rate of cancer coming back (or recurring) in the pelvic area between the two groups. Three years after undergoing surgery, they found that the pelvic recurrence rate was similar between the two groups. The cancer recurred in 2.5% of women who got a simple hysterectomy, compared with 2.2% of women who got a radical hysterectomy. Overall, after about 4.5 years, cancer recurred in 11 women in the simple hysterectomy group and 10 in the radical hysterectomy group.
Survival was also similar in both groups. The percentage of women who were still alive 3 years after surgery was 99.1% in the simple hysterectomy group and 99.4% in the radical hysterectomy group.
Importantly, women who had a simple hysterectomy had fewer complications during surgery as well as less immediate and long-term bladder problems. Sexual function was also better in the simple hysterectomy group, and those women reported less pain and an overall better quality of life.
“Therefore, following adequate and rigorous preoperative assessment — and that’s key — simple hysterectomy can now be considered the new standard of care for patients with low-risk, early-stage cervical cancer,” said Plante.
Bhavana Pothuri, MD, a gynecological oncologist at New York University Langone Perlmutter Cancer Center, said that this trial is very exciting as it “represents ways of minimizing treatments while preserving efficacy of our cancer treatments.”
“The general takeaways are that doing less radical surgery in this group of early cervical cancers is safe and effective,” said Pothuri, who was not involved in the study.
DON DIZON: Hi. Don Dizon. I’m a professor of medicine and professor of surgery at Brown University, and I treat pelvic cancers. And I’m here at ASCO ’23. And one of the studies that was presented was called the SHAPE Trial, and it looked at people presenting with early cervical cancer. This was disease that was limited to cervix– not very big.
And the approach is typically a very complicated surgical procedure that you need specialized training to do called a radical hysterectomy, where they not only take the cervix and the uterus, but the surgery goes out to the pelvic sidewalls. And it can be a very complicated procedure with perioperative complications. But if you did not have cervical cancer, the standard procedure if you need to have your uterus removed is just a simple hysterectomy. So that’s just removing the cervix and the uterus and not doing this complicated procedure that extends to the pelvic area and the side wall.
This study tested that simpler procedure versus the standard radical procedure and ultimately showed that at three years, the survival outcomes were the same and that quality of life was better with a simple hysterectomy, particularly as it related to sexual quality of life.
DON DIZON: Hi, I’m Don Dizon. I’m a professor of medicine and professor of surgery at Brown University. And I treat pelvic cancers. One of the studies presented at ASCO 23 was the overall survival results if you add a checkpoint inhibitor to the treatment of metastatic cervical cancer.
In this study, women with cervical cancer that had gone somewhere else or had metastasized, were randomly assigned to standard treatment with chemotherapy with or without a drug called bevacizumab, which blocks a specific protein called vascular endothelial growth factor with or without a checkpoint inhibitor called pembrolizumab.
And these data, which are updated analyses shows, if we added pembrolizumab to that standard two-drug or three-drug combination, we improved overall survival by about a year. So these data truly suggest, where it’s available, chemotherapy with pembrolizumab plus or minus the use of bevacizumab is the standard of care for people living with metastatic cervical cancer.
DON DIZON: This is Don Dizon. I’m a professor of medicine and professor of surgery at Brown University, and I treat pelvic cancers.
One of the studies presented here at ASCO ’23 was called the MIRASOL trial, and this study took people with recurrent ovarian cancer whose disease had come back early after attempted treatment with a platinum and a taxane standard combination with, hopefully. The intent to cure them. So if the disease comes back early, usually around six months or less, that situation is called platinum resistance.
The MIRASOL trial took people with platinum-resistant ovarian cancer and treated them with a novel drug called mirvetuximab or standard chemotherapy. And this study showed overall survival benefits with this new drug, mirvetuximab, over standard of care chemotherapy, importantly, in a selected group of people whose tumors expressed a protein called folate receptor alpha. So again, for those people who had high-expressing folate receptor alpha ovarian cancer whose disease recurred early after chemotherapy, mirvetuxim
