Simple Hysterectomy Not Inferior to Radical Hysterectomy in Preventing Cancer Reoccurrence Among Patients With Low-Risk Cervical Cancer

In a multicenter, randomized, noninferiority trial, researchers observed that for patients with low-risk cervical cancer, a simple hysterectomy was not inferior to a radical hysterectomy in preventing cancer reoccurrence in the pelvic area within three years.

A radical hysterectomy is the standard of care for early-stage cervical cancer treatment. However, observational studies suggest no difference in survival rates for patients with stage IA2 cervical cancer who undergo radical hysterectomy and those who undergo simple hysterectomy. Retrospective data indicate that parametrial infiltration is less than 1% in patients with stage IB1 low-risk cervical cancer, suggesting that less radical surgery may be a safe alternative. Despite these findings, concerns about worse outcomes with simple hysterectomy persist due to the limitations of previous studies and incomplete data. The Simple Hysterectomy and Pelvic Node Assessment trial was designed to provide robust evidence comparing the safety and efficacy of simple versus radical hysterectomy in patients with low-risk, early-stage cervical cancer.

The researchers conducted an international, multicenter, randomized noninferiority trial comparing radical hysterectomy with simple hysterectomy, including lymph-node assessment, in patients with low-risk cervical cancer (lesions ≤2 cm with limited stromal invasion). Eligible patients met the International Federation of Gynecology and Obstetrics 2009 criteria for stage IA2 or IB1 tumors, and had squamous-cell, adenocarcinoma, or adenosquamous carcinoma without lymph-node metastasis.

Patients were randomly assigned 1:1 to undergo radical or simple hysterectomy, with surgery including pelvic lymph-node dissection and optional sentinel-node mapping. The primary outcome was pelvic cancer recurrence at 3 years, with secondary outcomes including overall survival, recurrence-free survival, surgical complications, and patient-reported outcomes. Analyses were conducted using intention-to-treat and per-protocol approaches. Statistical analysis employed Kaplan-Meier estimates, Cox proportional-hazards models, and Fisher's exact test for categorical outcomes.

After a median follow-up of 4.5 years, the incidence of pelvic recurrence at 3 years was 2.17% in the radical hysterectomy group and 2.52% in the simple hysterectomy group, with an absolute difference of 0.35 percentage points (90% CI, −1.62 to 2.32), demonstrating noninferiority. Urinary incontinence was significantly lower in the simple hysterectomy group both within 4 weeks after surgery (2.4% vs. 5.5%; P = .048) and beyond 4 weeks (4.7% vs. 11.0%; P = .003). Similarly, urinary retention was significantly lower in the simple hysterectomy group within 4 weeks (0.6% vs. 11.0%; P < .001) and beyond 4 weeks (0.6% vs. 9.9%; P < .001).

The main limitations of this trial include the small number of events, leading to wide confidence intervals for time-to-event outcomes, and a median follow-up time of 4.5 years, which may not capture all disease recurrences.

“In patients with low-risk cervical cancer, simple hysterectomy was not inferior to radical hysterectomy with respect to the 3-year incidence of pelvic recurrence and was associated with a lower risk of urinary incontinence or retention,” the study authors concluded.

Reference

Plante M, Kwon JS, Ferguson S, et al. Simple versus radical hysterectomy in women with low-risk cervical cancer. N Engl J Med. 2024;390:819-829. doi: 10.1056/NEJMoa2308900.