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

Year of Publication

2024

Hypothesis

Simple hysterectomy is non-inferior to radical hysterectomy in preventing pelvic recurrence in patients with low-risk early-stage cervical cancer.

Inclusion Criteria Table

• LVSI was not an exclusion criteria
• Choice of Open vs. MIS left to surgeon

Exclusion Criteria

Lesions >2 cm, evidence of metastatic disease on preoperative imaging, other histologic subtypes.

Primary Endpoint

Pelvic recurrence within 3 years post-operation.

Experimental Arm(s)

Simple hysterectomy including lymph-node assessment.

Control Arm (or standard therapy)

Radical hysterectomy (type II) including lymph-node assessment.

Results Table with More Details

• 700 patients (350 in each group)
• 92% 1B1 patients
• 62% SCC
• 80% Prior Leep or cone
• 83% MIS cases in Simple Hyst Arm; 71% MIS cases in Rad Hyst Arm

| Outcome | Simple Hysterectomy Group | Radical Hysterectomy Group | P-value |
|---------|---------------------------|-----------------------------|---------|--------------|
| 3-Year Pelvic Recurrence Rate | 2.52% | 2.17% | NS |
| Urinary Incontinence (beyond 4 weeks) | 4.7% | 11% | 0.003 |
| Urinary Retention (<4 weeks) | 0.6% | 11% | <0.001 |
| Urinary Retention (beyond 4 weeks) | 0.6% | 9.9% | <0.001 |
| Intr-op Injury | 7.1% | 6.4% | NS|

Pelvic Recurrence Rates by Surgical Type and Approach

Conclusions

Simple hysterectomy is not inferior to radical hysterectomy regarding the 3-year incidence of pelvic recurrence and presents a lower risk of urinary complications.

Limitations

• Small number of events leading to wide confidence intervals.
• Follow-up period (median of 4.5 years) may not capture all recurrences.
• Surgical approach (open vs. minimally invasive) was not a stratification factor.
• Results may not be generalizable to non-low-risk patients or underrepresented populations.