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

Background: Retrospective data suggest that the incidence of parametrial infiltration is low in patients with early-stage low-risk cervical cancer, raising questions regarding the need for radical hysterectomy in these patients. Large randomized trials comparing outcomes of radical and simple hysterectomy have been lacking. Methods: In a multicenter, randomized, noninferiority trial, we compared radical hysterectomy with simple hysterectomy including lymph-node assessment in patients with low-risk cervical cancer (lesions ≤2 cm with limited stromal invasion). The primary outcome was pelvic recurrence at 3 years. The prespecified noninferiority margin for the between-group difference was 4 percentage points. Results: Among 700 randomized patients (350 per group), most had FIGO 2009 stage IB tumors (91.7%), squamous histology (61.7%), and grade 1 or 2 (59.3%). With median follow-up of 4.5 years, the 3-year pelvic recurrence incidence was 2.17% in the radical hysterectomy group and 2.52% in the simple hysterectomy group (absolute difference, 0.35 percentage points; 90% CI, −1.62 to 2.32). Per-protocol results were similar. Urinary incontinence was lower with simple hysterectomy within 4 weeks (2.4% vs. 5.5%; P=0.048) and beyond 4 weeks (4.7% vs. 11.0%; P=0.003). Urinary retention was also lower with simple hysterectomy within 4 weeks (0.6% vs. 11.0%; P<0.001) and beyond 4 weeks (0.6% vs. 9.9%; P<0.001). Conclusions: In low-risk cervical cancer, simple hysterectomy was noninferior to radical hysterectomy regarding 3-year pelvic recurrence and was associated with a lower risk of urinary incontinence and retention. (Funded by the Canadian Cancer Society and others; ClinicalTrials.gov number, NCT01658930.)