KEY TAKEAWAYS
- The SHAPE trial aimed to assess if radical hysterectomy is necessary in early-stage low-risk cervical cancer patients by comparing outcomes with a simple hysterectomy.
- Simple hysterectomy showed comparable pelvic recurrence rates and lower urinary incontinence/retention risks than radical hysterectomy.
Past data indicates that the occurrence of parametrial infiltration appears to be minimal among individuals with early-stage low-risk cervical cancer. This prompts inquiries into the necessity of radical hysterectomy for such patients. Nonetheless, there is a dearth of substantial evidence from extensive, randomized trials comparing the outcomes of radical and simple hysterectomy procedures.
Marie Plante and her team aimed to investigate if radical hysterectomy is warranted for early-stage low-risk cervical cancer by analyzing outcomes in large randomized trials.
This multicenter, randomized, noninferiority trial compared radical hysterectomy with simple hysterectomy, including lymph node assessment, in patients diagnosed with low-risk cervical cancer (lesions of ≤2 cm with limited stromal invasion). The primary outcome under scrutiny was cancer recurrence in the pelvic area (pelvic recurrence) at 3 years. The prespecified noninferiority margin for the between-group difference in pelvic recurrence at 3 years was set at 4 percentage points.
Among the 700 patients randomized (350 in each group), the majority presented with tumors classified as stage IB1 per the 2009 International Federation of Gynecology and Obstetrics (FIGO) criteria (91.7%), characterized by squamous-cell histologic features (61.7%) and graded as 1 or 2 (59.3%). With a median follow-up duration of 4.5 years, the incidence of pelvic recurrence at 3 years stood at 2.17% in the radical hysterectomy group and 2.52% in the simple hysterectomy group, reflecting an absolute difference of 0.35 percentage points (90% CI -1.62 to 2.32). Consistent findings were observed in a per-protocol analysis.
The prevalence of urinary incontinence post-surgery was lower in the simple hysterectomy group compared to the radical hysterectomy group both within 4 weeks after surgery (2.4% vs. 5.5%; P = 0.048) and beyond 4 weeks (4.7% vs. 11.0%; P = 0.003). Similarly, the incidence of urinary retention within 4 weeks post-surgery was lower in the simple hysterectomy group compared to the radical hysterectomy group (0.6% vs. 11.0%; P<0.001), as well as beyond 4 weeks (0.6% vs. 9.9%; P<0.001).
The study concluded that among individuals diagnosed with low-risk cervical cancer, simple hysterectomy proved to be non-inferior to radical hysterectomy regarding the 3-year incidence of pelvic recurrence. Additionally, opting for a simple hysterectomy was linked to a reduced risk of experiencing urinary incontinence or retention. Research was funded by the Canadian Cancer Society and others.
Source: https://pubmed.ncbi.nlm.nih.gov/38416430/
Clinical Trial: https://clinicaltrials.gov/study/NCT01658930
Plante M, Kwon JS, Ferguson S, et al. (2024) “Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer.” N Engl J Med 2024; 390:819-829 DOI: 10.1056/NEJMoa2308900.
