A multicenter, randomized, noninferiority trial determined that a simple hysterectomy may be as effective as a radical hysterectomy in preventing cancer recurrence among women with early-stage, low-risk cervical cancer.

In the study, published in the The New England Journal of Medicine, researchers compared the outcomes of 700 patients across two treatment groups after a median follow-up period of 4.5 years.

The trial included patients with cervical cancer lesions measuring ≤ 2 cm and limited stromal invasion. Most tumors were stage IB1 (91.7%) and had squamous-cell histologic features (61.7%). The primary endpoint was the 3-year incidence of pelvic recurrence, with a prespecified noninferiority margin of 4 percentage points.

At 3 years, pelvic recurrence rates were 2.17% in the radical hysterectomy group and 2.52% in the simple hysterectomy group. The absolute difference of 0.35 percentage points (90% confidence interval [CI] = −1.62 to 2.32) fell within the noninferiority margin, indicating comparable effectiveness between the two procedures.

In addition to similar recurrence rates, simple hysterectomy was associated with significantly lower rates of urinary complications. Within 4 weeks of the procedures, urinary incontinence occurred in 2.4% of patients in the simple hysterectomy group compared with 5.5% of those in the radical hysterectomy group (P = .048). Beyond 4 weeks, incontinence rates were 4.7% vs 11.0%, respectively (P = .003).

Urinary retention was also notably reduced in the simple hysterectomy group, occurring in 0.6% of patients within 4 weeks compared with 11.0% in the radical group (P < .001). Similar trends persisted beyond 4 weeks, with retention rates of 0.6% vs 9.9% (P < .001).

The researchers highlighted that these findings could influence surgical decision-making in patients with low-risk cervical cancer.

"[S]imple hysterectomy was [non]-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," emphasized lead study author Marie Plante, MD, of the Centre Hospitalier Universitaire de Québec at the University of British Columbia in Vancouver, and her colleagues.

This trial provided the first large-scale, randomized evidence comparing the two surgical techniques in this patient population.

The study was funded by the Canadian Cancer Society and other organizations, and no conflicts of interest were reported.