New practice-changing findings published today in the New England Journal of Medicine, suggest that opting for a simple hysterectomy is a safe, effective, and less invasive treatment option for women with low-risk early-stage cervical cancer. The CX5/SHAPE clinical trial led by the Canadian Cancer Trials Group (CCTG) at Queen’s examined the three-year pelvic recurrence rate in patients who underwent a radical hysterectomy versus those who had a simple hysterectomy where only the uterus and cervix are removed.

The findings suggest that the simpler approach significantly reduces surgical complications and presents a potential shift in the standard of care for these patients.

Funded by the Canadian Institutes of Health Research and the Canadian Cancer Society, the Phase III trial involved 700 women from 12 countries, with 26 per cent of all patients recruited from Canadian centers. The findings also revealed that the less invasive surgery may lead to improved quality of life, as it reduces the risks of long-term side effects, including three times more bladder injuries, nearly twice as many ureteral injuries, as well as compromised bowel and sexual function.

The study chair, Dr. Marie Plante, a gynecologic oncologist from CHU de Quebec, Laval University, says, “These results will likely be practice-changing with the new standard-of-care treatment being a simple hysterectomy instead of radical hysterectomy.”

Cervical cancer is recognized as the fourth most prevalent cancer and a leading cause of cancer-related deaths in women worldwide by the World Health Organization. There are over 600,000 cases and 350,000 deaths each year, predominantly in low and middle-income countries where the disease is endemic. These findings, if integrated into clinical practice, could have significant implications for low-risk, early-stage cervical cancer management globally, offering a less burdensome, yet equally effective, treatment option for eligible patients. It may also lead to more accessibility to treatment pathways, particularly in less affluent regions.

"The global impact of these results is important to note, as surgical de-escalation may allow women in low and middle-income countries easier access to less radical surgical interventions."

– Dr. Lois Shepherd

CX5 senior investigator and professor in the Department of Pathology and Molecular Medicine at Queen’s

The research was conducted in collaboration with several international partners, highlighting its broad scope and significance in global cancer research. For more information on this and other clinical trials supported by Queen’s and CCTG, visit the Canadian Cancer Trials Group website.

 

---

The study is an international collaboration with The Gynecological Cancer InterGroup (GCIG) that includes partners: Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Dutch Gynecologic Oncology Group (DGOG), National Cancer Research Institute (NCRI), Arbeitsgemeinschaft Gynaekologische Onkologie Studiengruppe Ovarialkarzinom (AGO Studiengruppe), Belgium Gynecologic Oncology Group (BGOG), Arbeitsgemeinschaft Gynaekologische, Onkologie Austria (AGO Austria), Oslo University Hospital - The Norwegian Radium Hospital, Korean Gynecologic Oncology Group (KGOG), and All Ireland Cooperative Oncology Research Group (ICORG).