Simple hysterectomy noninferior vs radical hysterectomy for cervical cancer

Simple hysterectomy noninferior vs radical hysterectomy for cervical cancer | Image Credit: © Jo Panuwat D - © Jo Panuwat D - stock.adobe.com.

Simple hysterectomy is not inferior to radical hysterectomy in regards to pelvic recurrence within 3 years, and also leads to reduced risks of urinary incontinence and retention, according to a recent study published in the New England Journal of Medicine.¹

An invasive cervical cancer diagnosis was reported in over 600,000 individuals worldwide in 2020.² This condition is often treated through radical hysterectomy, but data has indicated no significant differences in survival rate from this procedure vs simple hysterectomy in stage IA cervical cancer.¹

Reduced odds of parametrial infiltration have also been reported from less radical surgery, indicating it as a potentially safer option in certain populations. However, current data comes from studies that vary in quality, highlighting a need for further research.

To compare the safety of simple hysterectomy with radical hysterectomy in low-risk early-stage cervical cancer patients, investigators conducted a phase 3, international, randomized trial. Participants were randomized 1:1 to receive either simple or radical hysterectomy.

Eligibility criteria included having squamous-cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix stage IA2 or IB1 tumors, limited cervical stromal invasion depth, and a histologic-grade tumor. Patients with other histologic subtypes, lesions over 2 cm, or evidence of metastatic disease were excluded from the analysis.

Type 2 radical hysterectomy involved removal of the uterus cervix, one-third of parametria, 2 cm of the uterosacral ligaments, and upper 1 to 2 cm of the vagina. During simple hysterectomy, the uterus with the cervix was removed without adjacent parametria. Complete removal of the cervix was ensured through a maximum 0.5 cm removal of the vaginal cuff.

An open vs minimally invasive surgical approach was determined through surgeon decision. Pelvic lymph-node dissection was performed in all procedures.

Cancer recurrence in the pelvic area within 3 years was reported as the primary outcome. This was based on disease presence below the pelvic brim and inferior to the L4 to L5 vertebral level.

Secondary outcomes included sentinel-node detection, parametrial involvement, disease at margins of surgically removed tissues, and pelvic-node involvement. Assessments were performed 4 to 6 weeks after surgery and at 3 months, then at 3-month intervals during week 1, 4-month intervals during year 2, 6-month intervals during year 3, and 12-month intervals until death or end of follow-up.

There were 700 participants included in the final analysis, 91.7% of whom had stage IB1 disease, 61.7% squamous histologic type, and 59.2% grade 1 or 2 disease. Similar baseline characteristics were reported between groups.

The odds of abdominal surgery were reduced in simple hysterectomy patients vs radical hysterectomy patients, at 16.9% vs 28.8%, respectively. However, laparoscopic surgery was more likely in these patients, at 55.6% vs 44.2%, respectively. Similar rates of robotic surgery were reported, at 24.3% vs 25.3%, respectively.

Loop electrosurgical excision procedure or conization occurred in 80.2% of patients. Residual disease in the hysterectomy specimen was reported in 40% of these patients who received simple hysterectomy vs 37% who received radical hysterectomy.

Of patients receiving simple hysterectomy, 37.3% underwent sentinel lymph-node mapping, vs 38.2% receiving radical hysterectomy. The procedure was successful in 61.9% vs 63.4% of these patients, respectively.

There were 11 pelvic recurrences reported in the simple hysterectomy group vs 10 in the radical hysterectomy group. These incidences were identified during median follow-up periods of 4.5 and 4.6 years, respectively, Incidence rates were 2.52% and 2.17%, respectively, indicating a difference of 0.35%.

Pelvic recurrence was found in 3.2% of simple hysterectomy patients receiving minimally invasive surgery vs 3.5% receiving open surgery. For radical hysterectomy, these rates were 2.9% and 3%, respectively.

Intraoperative surgical complications were reported in 7.1% of the simple hysterectomy group vs 6.4% of the radical hysterectomy group. Bladder injuries occurred in 0.9% and 2.6%, respectively, and ureteral injuries in 0.9% and 1.5%, respectively.

These results indicated noninferiority from simple hysterectomy vs radical hysterectomy in low-risk cervical cancer patients. Investigators noted that alongside noninferiority toward recurrence at 3 years, simple hysterectomy also led to reduced urologic complications.

References

1. Plante M, Kwon JS, Ferguson S, et al. Simple versus radical hysterectomy in women with low-risk cervical cancer. N Engl J Med. 2024;390(9):819-829. doi:10.1056/NEJMoa2308900
2. Cancer stat facts: Cervical cancer. National Cancer Institute. Accessed December 9, 2024. https://seer.cancer.gov/statfacts/html/cervix.html