Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer.

Randomized trialThe New England journal of medicine· Feb 2024

Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer.

Marie Plante, Janice S Kwon, Sarah Ferguson … CX.5 SHAPE Investigators

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Gynecologic CancerRandomized trialTreatmentQ1IF 19.7

Simple hysterectomy was noninferior to radical hysterectomy for low-risk cervical cancer

Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer.

Marie Plante … CX.5 SHAPE Investigators

The New England journal of medicine · Feb 2024 · Q1 in General Medicine

Background

Retrospective data suggest that the incidence of parametrial infiltration is low in patients with early-stage low-risk cervical cancer, which raises questions regarding the need for radical hysterectomy in these patients.

Methods

We conducted a multicenter, randomized, noninferiority trial comparing radical hysterectomy with simple hysterectomy including lymph-node assessment in patients with low-risk cervical cancer (lesions of ≤2 cm with limited stromal invasion).

n = 700 patients

Results

similarly low rate of cancer returning in the pelvis after simpler, less extensive surgery

absolute difference 0.35 (95% CI -1.62 to 2.32)

CI crosses the null - not significant

More results

Among 700 patients who underwent randomization (350 in each group), the majority had tumors that were stage IB 1 according to the 2009 International Federation of Gynecology and Obstetrics (Federation of Gynecology and Obstetrics) criteria (91.7%), that had squamous-cell histologic features (61.7%), and that were grade 1 or 2 (59.3%).

More results

Results were similar in a per-protocol analysis.

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Conclusion · 1 of 2

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.

Conclusion · 2 of 2

(Funded by the Canadian Cancer Society and others; ClinicalTrials.gov number, NCT01658930.).

Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer.

Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer.

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