Simple Hysterectomy Noninferior to Radical Hysterectomy in Low-Risk Cervical Cancer

Patients with low-risk cervical cancer have similar rates of pelvic recurrence whether they undergo a simple hysterectomy or a radical hysterectomy, according to research published in The New England Journal of Medicine.

Researchers found that the 3-year incidence of pelvic recurrence was not significantly different with the 2 surgeries, and simple hysterectomy was associated with a lower risk of urinary incontinence or retention.

These results come from the phase 3 SHAPE trial (ClinicalTrials.gov identifier: NCT01658930), which included 700 patients with low-risk cervical cancer. They had squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, FIGO 2009 stage IA2 or IB1 tumors, lesions measuring 2 cm or smaller, and limited depth of cervical stromal invasion.

The patients were randomly assigned to undergo simple hysterectomy or radical hysterectomy. The intent-to-treat (ITT) population included 350 patients in each arm. However, the number of evaluable patients who were treated per protocol was 317 in the simple hysterectomy arm and 312 in the radical hysterectomy arm.

The median follow-up was 4.5 years in the simple hysterectomy arm and 4.6 years in the radical hysterectomy arm.

In the ITT population, the incidence of pelvic recurrence at 3 years was 2.52% in the simple hysterectomy arm and 2.17% in the radical hysterectomy arm. The between-arm difference was 0.35 percentage points, which met criteria for noninferiority.

The overall rate of pelvic recurrence in the ITT population was 3.1% in the simple hysterectomy arm and 2.9% in the radical hysterectomy arm (hazard ratio [HR], 1.12; 95% CI, 0.47-2.67). In the per-protocol population, the rate of pelvic recurrence was 3.2% in both arms (HR, 1.01; 95% CI, 0.42-2.44).

The rate of any disease recurrence in the ITT population was 4.3% in the simple hysterectomy arm and 2.9% in the radical hysterectomy arm (HR, 1.54; 95% CI, 0.69-3.45). In the per protocol population, the rate of disease recurrence was 3.8% and 3.2%, respectively (HR, 1.19; 95% CI, 0.51-2.77).

The rate of death in the ITT population was 2.0% in both arms (HR, 1.09; 95% CI, 0.38-3.14). In the per-protocol population, the rate of death was 0.9% in the simple hysterectomy arm and 1.3% in the radical hysterectomy arm (HR, 0.71; 95% CI, 0.16-3.21).

The safety analysis included 338 patients in the simple hysterectomy arm and 344 in the radical hysterectomy arm. The rate of intraoperative surgical complications was 7.1% in the simple hysterectomy arm and 6.4% in the radical hysterectomy arm (P =.77). The rate of bladder injuries was 0.9% and 2.6%, respectively (P =.14). And the rate of ureteral injuries was 0.9% and 1.5%, respectively (P =.73).

The overall incidence of surgery-related adverse events within 4 weeks of surgery was 42.6% in the simple hysterectomy arm and 50.6% in the radical hysterectomy arm (P =.04). The incidence of urinary incontinence within 4 weeks was 2.4% and 5.5%, respectively (P =.05). The incidence of urinary incontinence beyond 4 weeks was 4.7% and 11.0%, respectively (P =.003).

The incidence of urinary retention within 4 weeks of surgery was 0.6% in the simple hysterectomy arm and 11.0% in the radical hysterectomy arm (P <.001). The incidence of urinary retention beyond 4 weeks was 0.6% and 9.9%, respectively (P <.001).

Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

This article originally appeared on Cancer Therapy Advisor