Simple hysterectomy is the ‘new standard’ for low-risk early-stage cervical cancer

Simple hysterectomy is a ‘novel’ option for patients with low-risk early-stage cervical cancer, according to the lead author of a new study that found that simple hysterectomy was as effective as radical hysterectomy and pelvic nodule removal. Anatomy of such patients has come to be considered ‘standard of care’.

Canadian Cancer Clinical Trials Group CX.5/SHAP Results

E-Trial announced ahead of the 2023 ASCO Annual Meeting in Chicago this weekend.

“Definitive surgery is highly effective in treating low-risk populations, but women are at risk of suffering survival issues, especially related to long-term surgical side effects such as bladder, bowel, and sexual dysfunction. The study’s lead author, Dr. Marie Plante, professor of obstetrics, gynecology and reproductive medicine at Laval University in Quebec City, Canada, said in a press conference ahead of the conference that the radical approach added that uterine parameters and resection of the upper vagina were also included. “Thus, radical surgery requires more extensive surgical skills and training and is associated with more surgical complications.”

According to the National Cancer Institute, a radical hysterectomy involves removal of the uterus, cervix, part of the vagina, and the tissue and ligaments surrounding these organs. A simple hysterectomy, on the other hand, only involves removing the uterus and cervix.

With a median follow-up of 4.5 years, the pelvic recurrence rate was similar in the two groups, 2.52% for patients who underwent simple hysterectomy and 2.17% for those who underwent radical hysterectomy.

Although the overall incidence of cervical cancer has declined over the past 20 years, Plante said there is a higher proportion of women who develop cervical cancer at younger ages and those with lower-risk early-stage disease. rice field.

Retrospective data suggest that less radical surgery, considered a surgical de-escalation approach, may not only be a safer option for patients, but may also be associated with reduced morbidity. suggests that

SHAPE is an intergroup study of gynecologic cancers led by the Canadian Cancer Trials Group involving 700 women with low-risk cervical cancer (squamous, adenocarcinoma, or adenosquamous) and Stage 1A2 or 1B1 disease. Parenchymal invasion <10 mm in loop electrosurgical resection/cone. <50% stromal invasion, 20 mm in greatest dimension, grade 1-3 or non-evaluable disease on MRI.

Half of the participating patients were randomly selected to undergo radical hysterectomy, and the other half underwent simple hysterectomy. Surgery included pelvic lymphadenectomy and optional sentinel lymph node (SN) mapping, regardless of which arm they were enrolled in. Although it is preferable to use a laparoscopic approach when performing SN mapping, this mode was optional.

Patients were randomized by cooperation group, SN mapping (yes vs. no), stage (1A2 vs. 1B1), histology (squamous vs. adenocarcinoma/adenosquamous carcinoma), grade (1-2 vs. 3 vs. non-evaluable). Stratified.

The primary endpoint of the trial is the 3-year pelvic recurrence rate.

Additional findings included: 1B1 histologic stage, squamous, adenocarcinoma/adenosquamous, tumor grade 1-2, non-evaluable tumor grade, pre-defined patients and patients following protocol excluded eligibility Simple hysterectomy was shown to be non-inferior to radical hysterectomy across prespecified patient subgroups, including I was not satisfied after surgery.

Additionally, the data showed a pelvic recurrence rate of 3.1% in patients who had a simple hysterectomy compared to 2.9% in those who had a radical hysterectomy. Extrapelvic recurrence (recurrence occurring outside the pelvis) occurred in 2.% and 0.6% of patients, respectively, and the pelvic and extrapelvic recurrence rates were 0.9% and 0.6%, respectively. The extrapelvic-only recurrence rate was 1.1% in the simple hysterectomy group and 0% in the radical approach group. Intrapelvic or extrapelvic recurrence rates were 4.3% and 2.9%, respectively.

There were 7 deaths in both groups, 4 deaths from cervical cancer with simple hysterectomy versus 1 death with radical hysterectomy.

Regarding postoperative complications, intraoperative injuries occurred in 24 patients undergoing simple hysterectomy and 22 patients undergoing radical hysterectomy. These occurred in the bladder, ureters, nerves, intestines, veins, etc.

Surgery-related side effects occurred within 4 weeks after surgery in 42.6% of patients in the simple hysterectomy group and 50.6% in the radical hysterectomy group. Four weeks after surgery, side effects occurred in 53.6% of patients and 60.5% of hers, respectively. The simple hysterectomy group had fewer side effects of acute urinary incontinence than the radical hysterectomy group.

Quality of life and sexual health were also assessed, with simple hysterectomy after 3, 6, and 12 months improving sexual vaginal function, and simple hysterectomy at the same interval yielding similar findings with respect to sexual pain. Got. Plante added that both approaches were further evaluated through sexual health scores, favoring the simple hysterectomy group.

Dr. Kathleen N. Moore, Associate Director of Clinical Research at Stevenson Cancer Center, Director of the Oklahoma TSET Phase I Program, and Professor of Gynecologic Oncology at the University of Oklahoma School of Medicine, said at a press conference: commented as Global impact of her SHAPE findings after presentation of Plante’s data.

“The SHAPE trial shows that radical hysterectomy can be changed to simple hysterectomy, including minimally invasive, in carefully selected tumors. It’s an important thing to do,” emphasized Moore. “But we can do this without losing control of the tumor and, importantly, we can reduce surgical complications, postoperative morbidity, especially urological morbidity.” In an instant, this will become the new standard of care.This represents a major step forward in the care of women with early-stage cervical cancer.In all honesty, the de-escalation will allow women in low- and middle-income countries to …) may be more susceptible to curative surgical intervention.”

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