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GOG 174

Phase III Trial of Weekly Methotrexate or Pulsed Dactinomycin for Low-Risk Gestational Trophoblastic Neoplasia: A Gynecologic Oncology Group Study

Date of Publication:

March 1, 2011

Pubmed Link:
https://pubmed.ncbi.nlm.nih.gov/21263100/
Hypothesis:

Does MTX or dactinomycin result in higher rates of complete response in women with low-risk GTN?

Control Arm(s):

pelvic US, CXR, hcgq1 wk IM MTX 30mg/m2until 1 cycle after normal hcg

Experimental Arm(s):

pelvic US, CXR, hcgq2 wk IV dactinomycin 1.25mg/m2until 1 cycle after normal hcg

Primary End Point:

complete response = normal hcg over 4 weeks

Inclusion Criteria:

WHO score 0-6

Exclusion Criteria:
Results:

MTX (n=107) vs dactinomycin (n=109):complete response: 53% vs 70% (SS)median # of cycles for CR: 8 vs 4WHO score 0-4: 58% vs 73% (SS)WHO score 5-6: 9% vs 42% hcg predictive of responsemore toxicity with dactinomycin (GI, N/V, dermatologic, neutropenia)

Conclusions:

Dactinomycin results in a higher rate of complete response than MTX in women with low-risk GTN, but carries more toxicity

Reviewer:
Olga T Filippova