New study results show that simple hysterectomy is a safe option for women with early-stage, low-risk cervical cancer

CX5 | SHAPE trial demonstrates that reduced radicality of surgical intervention can improve quality of life for patients

Friday, June 02, 2023

A simple hysterectomy with pelvic node dissection is a safe treatment option for women with low-risk early-stage cervical cancer and may help improve quality of life, according to results from the CX5/SHAPE study, an international phase III clinical trial led by the Canadian Cancer Trials Group in collaboration with The Gynecological Cancer InterGroup (GCIG). The research findings were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

dr Marie Plante — Dr Marie Plante, the CX5 study lead

The research concludes that treatment for early-stage, low-risk cervical cancers may be de-escalated with a simple hysterectomy compared to the standard radical hysterectomy.  This 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 Gynecologic Oncologist at CHU de Quebec, Canada. “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.”

The study looked at the three-year pelvic recurrence rate in patients receiving a radical hysterectomy (RH) versus those who had a simple hysterectomy (SH) where only the uterus and cervix are removed. 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.

Dr Brotto — Lori A. Brotto, Professor, UBC Faculty of Medicine

“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,” says Lori A. Brotto, Professor, UBC Faculty of Medicine and Executive Director, Women's Health Research Institute.

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.

About the study

The SHAPE study included 700 women ages 24 to 80 with low-risk, early-stage cervical cancer, defined as stage 1A2 or 1B1 disease, grade 1, 2, or 3, with lesions less than or equal to 2 centimeters and limited cervical stromal invasion. 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% of the overall patient population. Half of the hysterectomies were done laparoscopically (56% SH vs. 44% RH); 25% robotically (24% SH vs. 25% RH); and 23% abdominally (17% SH vs. 29% RH).

The primary endpoint of the study was to determine whether the pelvic recurrence rate at 3 years for SH was non-inferior to RH. To demonstrate non-inferiority of SH to RH, the upper limit of a one-sided 95% confidence interval for the difference in the pelvic recurrence rate at 3 years had to be lower than or equal to 4%. The pelvic recurrence rate was 2.52% for the SH group and 2.17% for the women receiving a RH with a difference of 0.35% and one-sided 95% confidence limit of 2.32%. Secondary endpoints included extra pelvic relapse-free survival, relapse-free survival, overall survival (OS), and quality of life.

About cervical cancer

Worldwide, cervical cancer is the fourth most diagnosed cancer and fourth most common cause of cancer death in women.  About 44% 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%.

"An investigator initiated surgical trial, like the SHAPE trial, which studied a relatively rare cancer, could not have been completed without the enthusiasm and willingness of international collaborators to participate in the trial through the auspices of Gynaecologic Cancer InterGroup.” Alison Brand GCIG Chair.

This was an academic study led by the Canadian Cancer Trials Group (CCTG) and was directly funded by the Canadian Institute of Health Research (CIHR) and in part by the Canadian Cancer Society (CCS). CX5/ SHAPE was conducted through an international collaboration with The Gynecological Cancer InterGroup (GCIG) that includes international partners : Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Dutch Gynecologic Oncology Group (DGOG), National Canacer 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), All Ireland Cooperative Oncology Research Group (ICORG).