Second Curettage for Low-Risk Nonmetastatic Gestational Trophoblastic Neoplasia (GOG 242)

Disease site

Uterus

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
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