A simple hysterectomy is a safe treatment option that can improve quality of life for women with early-stage, low-risk cervical cancer, according to results from the CX5/SHAPE study, an international phase III clinical trial involving UBC Faculty of Medicine researchers.
The study concludes that treatment for early-stage, low-risk cervical cancers may be de-escalated with a simple hysterectomy (SH), where only the uterus and cervix are removed, compared to the standard radical hysterectomy (RH), which removes the uterus, cervix, upper parts of the vagina and other nearby tissues.
Because RH is a more complex surgery, it is associated with more acute and long-term side effects, as well as potential impacts on quality of life and sexual health for patients.
“Sexual health and quality of life are very important considerations for patients undergoing cancer treatment. The findings from this study indicate that patients can expect fewer negative effects on sexual health and many other facets of quality of life with simple hysterectomy while not compromising effects on recurrence and survival rates,” said Dr. Lori Brotto, a professor of obstetrics and gynaecology at UBC and executive director of the Women’s Health Research Institute.
Led by the Canadian Cancer Trials Group in collaboration with The Gynecological Cancer InterGroup, the study looked at the three-year pelvic recurrence rate and other health outcomes in patients receiving RH and SH.
The findings, presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, show that the extra-pelvic recurrence-free survival, the relapse-free survival, and the overall survival were comparable between the two groups. There were fewer intraoperative urological surgical complications and fewer immediate and long-term bladder problems in the SH group. Several quality-of-life aspects, such as body image, pain, and sexual health, were consistently more favorable in the SH group.
“Sexual health and quality of life are very important considerations for patients undergoing cancer treatment.”
Dr. Lori Brotto
The research team says the study has potential implications beyond North America to parts of the world where cervical cancer is endemic.
“These results are important because it demonstrates, for the first time, that a simple hysterectomy is a safe option for women with carefully selected early-stage low-risk cervical cancer,” said Dr. Marie Plante, the CX5 study lead and a gynecologic oncologist at CHU de Quebec. “This trial will likely be practice-changing, with the new standard-of-care treatment for patients with low-risk disease being a simple hysterectomy instead of radical hysterectomy.”
Worldwide, cervical cancer is the fourth most diagnosed cancer and fourth most common cause of cancer death in women. About 44 per cent of women with cervical cancer are diagnosed with early-stage disease, of which a significant proportion will meet low-risk criteria, according to the study authors. When detected at an early stage, the 5-year relative survival rate for invasive cervical cancer is 92 per cent.
The SHAPE study included 700 women ages 24 to 80 with low-risk, early-stage cervical cancer. The participants, who came from 12 different countries, were randomized to receive pelvic node dissection and either RH or SH. Canada was the lead accruing country with 186 patients, or 26 per cent of the overall patient population.
The study was directly funded by the Canadian Institute of Health Research (CIHR) and in part by the Canadian Cancer Society (CCS).
This story is adapted from a news release by the Canadian Cancer Trials Group.