As reported by Marie Plante, MD, and colleagues in The New England Journal of Medicine, the phase III CX.5 SHAPE trial has shown noninferiority of simple vs radical hysterectomy in terms of pelvic recurrence in women with low-risk cervical cancer. Simple hysterectomy was associated with a reduced risk of urinary complications.
Marie Plante, MD
As stated by the investigators, “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. However, data from large, randomized trials comparing outcomes of radical and simple hysterectomy are lacking.”
Study Details
In the trial, 700 women with low-risk disease (lesions of ≤ 2 cm with limited stromal invasion) recruited from sites in 12 countries between December 2012 and November 2019 were randomly assigned to undergo simple hysterectomy (n = 350) or radical hysterectomy (n = 350). Most patients (91.7%) had stage IB1 tumors on 2009 International Federation of Gynecology and Obstetrics (FIGO) criteria (91.7%), squamous cell histologic features (61.7%), and tumor grade 1 or 2 (59.3%). The primary outcome measure was cancer recurrence in the pelvic area at 3 years; the prespecified noninferiority margin for the between-group difference was an upper 90% confidence interval of 4%.
Rates of Pelvic Recurrence
Median follow-up was 4.5 years. At 3 years, the incidence of pelvic recurrence was 2.52% in the simple hysterectomy group vs 2.17% in the radical hysterectomy group. The difference was 0.35% (90% confidence interval [CI] = −1.62% to 2.32%), with the upper limit of the confidence interval meeting the criterion for noninferiority.
In a per-protocol analysis including 317 patients in the simple hysterectomy group and 312 in the radical hysterectomy group, pelvic recurrence occurred in 3.2% vs 3.2% of patients, respectively (hazard ratio = 1.01, 95% CI = 0.42–2.44).
KEY POINTS
- At 3 years, the incidence of pelvic recurrence was 2.52% in the simple hysterectomy group vs 2.17% in the radical hysterectomy group.
- The incidence of urinary incontinence and retention was lower in the simple hysterectomy group vs the radical hysterectomy group within and after 4 weeks after surgery.
Rates of Complications
Intraoperative surgical complications occurred in 7.1% of 338 patients who underwent simple hysterectomy vs 6.4% of 344 who underwent radical hysterectomy; these included bladder injury in 0.9% vs 2.6% and ureteral injury in 0.9% vs 1.5%, respectively. Surgery-related adverse events within 4 weeks after surgery occurred in 42.6% vs 50.6% of patients (P = .04).
The incidence of urinary incontinence was lower in the simple hysterectomy group vs the radical hysterectomy group within 4 weeks after surgery (2.4% vs 5.5%, P = .048) and after 4 weeks (4.7% vs 11.0%, P = .003). The incidence of urinary retention was also lower in the simple hysterectomy group within 4 weeks after surgery (0.6% vs 11.0%, P < .001) and after 4 weeks (0.6% vs 9.9%, P < .001).
The investigators concluded, “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.”
Dr. Plante, of Centre Hospitalier Universitaire de Québec, is the corresponding author for The New England Journal of Medicine article.
Disclosure: The study was funded by the Canadian Cancer Society and others. For full disclosures of the study authors, visit nejm.org.
