SHAPE Trial: Simple versus Radical Hysterectomy in Women with Low-Risk Cervical Cancer
Simple Hysterectomy Safe for Some Cervical Cancers - PubMed
Findings from the SHAPE trial confirm that carefully selected women with early-stage cervical cancer can undergo a simple hysterectomy instead of a radical procedure without increasing their risk of disease recurrence. The findings are likely to set a new global standard of care for patients with lo …
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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
| Criteria | Details |
|---|---|
| FIGO Stage (2009) | IA2 or IB1 |
| Lesion Size | ≤2 cm |
| Depth of Stromal Invasion | <10 mm on LEEP or Cone; MRI <50% stromal invasion |
| Lymph Node Metastasis | No evidence on preoperative imaging |
| Histologic Subtypes | Squamous or adenocarcinoma or adenosquamous(Excludes other than specified for low-risk) |
- 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 | Hazard Ratio |
|---|---|---|---|---|
| 3-Year Pelvic Recurrence Rate | 3.2% | 3.5% | NS | NA |
| Urinary Incontinence | 2.4% | 5.5% | 0.048 | NA |
| Urinary Retention (<4 weeks) | 0.6% | 11% | <0.001 | NA |
| Urinary Retention (beyond 4 weeks) | 0.6% | 9.9% | <0.001 | NA |
| Intr-op Injury | 7.1% | 6.4% | NS | NA |
Pelvic Recurrence Rates by Surgical Type and Approach
| Group | Surgical Approach | Patients (N) | Pelvic Recurrences (N) | Recurrence Rate (%) |
|---|---|---|---|---|
| Simple Hysterectomy | Minimally Invasive | 281 | 9 | 3.2 |
| Simple Hysterectomy | Open Surgery | 57 | 2 | 3.5 |
| Radical Hysterectomy | Minimally Invasive | 243 | 7 | 2.9 |
| Radical Hysterectomy | Open Surgery | 99 | 3 | 3.0 |
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.
| Criteria | SHAPE Trial (Plante et al. 2024) | CONCERV Trial (Schmeler et al. 2021) |
|---|---|---|
| FIGO Stage | IA2 or IB1 | IA2–IB1 |
| Histology | Squamous or adenocarcinoma or adenosquamous (any grade) | Squamous cell (any grade) or adenocarcinoma (grade 1 or 2 only) |
| Tumor Size | ≤2 cm | <2 cm |
| Lymphovascular Space Invasion (LVSI) | Allowed | No LVSI allowed |
| Depth of Stromal Invasion | <10 mm or <50% on MRI | <10 mm (histology only) |
| Metastatic Disease | Negative imaging for metastatic disease | Negative imaging for metastatic disease with CT scan, MRI, and/or PET scan |
| Conization Margins | Positive Conization Margins allowed | Must have negative conization margins |
| Recurrence rate at 3 years | 3.6% | 3.5% |