Second Curettage for Low-Risk Nonmetastatic Gestational Trophoblastic Neoplasia (GOG 242)
Disease site
Uterus
Pubmed link
Publication month/year
September 2016
Study question
To define the efficacy and safety of second curettage in patients with persistent, nonmetastatic low-risk GTN
Type of study
Prospective two-stage single arm phase II study
Intervention (single arm)
Second Curettage for Low-Risk nonmetastatic GTN
Primary outcome
The efficacy & safety of second curettage
Secondary outcome
- Frequency & severity of adverse events
- Prognostic factors
Inclusion criteria
- Hydatidiform mole following initial curettage
- Persistently elevated β-hCG
- Nonmetastatic GTN
- WHO risk score of 0-6
Exclusion criteria
- Failing first-line therapy
- Positive or a suspicious chest radiograph
- First curettage diagnosis of choriocarcinoma, placental-site trophoblastic tumor, or epithelioid trophoblastic tumor
- An initial registration hCG level less than 20 milli-international units/mL
- Prior chemotherapy
Results
| Second Curettage for Low-Risk nonmetastatic GTN | |
|---|---|
| Total number (n) | 64 |
| Eligible patients (n) | 60 |
| Cure rate (%) | 40% |
| Patients avoided chemotherapy (%) | 46.7% |
| Surgical failure rate (%) | 59% |
Other results
- 45% derived clinical benefit from the second curettage
- 44% women between 20 and 39 years of age were cured by second curettage alone with 49% treatment success when surgical responses and cures were combined
- Cure was observed in 43.6% of the patients with WHO risk score of 4 or less
Conclusions
Second uterine curettage as initial treatment for low-risk, nonmetastatic GTN cures 40% of patients without significant morbidity.
Study limitations
- The patient numbers
- Lack of standardization that arises in multi-institution trials; especially in parts of statistical power and the technique for second uterine curettage