“Thanks to this study, we can do a less extensive surgery in patients with early-stage low-risk cervical cancer with the same survival but fewer side effects,” said Willemien van Driel, a gynecologist from the NKI. “This is a major advance for patients with cervical cancer who need to undergo this surgery.”
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.
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.
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, including 110 women from the Netherlands, were randomized to receive pelvic node dissection and either RH or SH.
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.
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.