Simple hysterectomy (SH) with pelvic node dissection is a safe treatment option for people with early-stage, low-risk cervical cancer and may help improve quality-of-life, according to results from a large, international phase 3 clinical trial presented at the 2023 American Society of Clinical Oncology Annual Meeting.
The current standard of care for people with early-stage, low-risk cervical cancer is pelvic node dissection and radical hysterectomy (RH) for people not wishing to preserve fertility, or radical trachelectomy, in which the cervix is removed but the uterus is left intact, for those wishing to preserve fertility.
However, the findings of the phase 3 SHAPE trial presented at the meeting confirm that in carefully selected patients, the surgery could be safely de-escalated to SH without impacting outcomes and ushers in a new, more individualised surgical approach for women with early-stage cervical cancer.
The SHAPE study included 700 people 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 ≤2cm. The participants, who came from 12 different countries, were randomised to receive pelvic node dissection and either RH or SH. Half of the hysterectomies were done laparoscopically (56 per cent SH vs 44 per cent RH); 25 per cent robotically (24 per cent SH vs 25 per cent RH); and 23 per cent abdominally (17 per cent SH vs 29 per cent RH).
The pelvic recurrence rate at three years with SH was not inferior to RH (2.5 per cent with SH vs 2.2 per cent with RH). The extrapelvic relapse-free survival (98.1 per cent with SH vs 99.7 per cent with RH) and the overall survival (99.1 per cent with SH vs 99.4 per cent with RH) were also comparable between the two groups. Overall, 21 pelvic recurrences were identified after a median follow-up of 4.5 years (11 in the SH group vs 10 in the RH group).
Additionally, those in the SH group experienced fewer intraoperative urological surgical complications and fewer immediate- and long-term bladder problems. Several quality-of-life aspects such as body image, pain, and more sexual activity were also more favourable in the SH group. The surgical approach used (abdominal surgery vs minimally invasive surgical approach) did not seem to influence risk of recurrence in either group. The rate of positive surgical margins was also low in both groups (2.6 per cent overall; 2.1 per cent with SH vs 2.9 per cent with RH).
“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 lead author Prof Marie Plante, Gynaecologic Oncologist, CHU de Quebec, and Professor, Department of Obstetrics and Gynaecology at Laval University in Quebec, Canada.
“This trial will likely be practise-changing, with the new standard-of-care treatment for patients with low-risk disease being a simple hysterectomy instead of radical hysterectomy.”