5-day methotrexate for women with metastatic gestational trophoblastic disease.

The objective of this study was to analyze the toxicity and the efficacy of single-agent 5-day methotrexate for women with metastatic gestational trophoblastic disease. The study is a retrospective analysis of 52 patients who received repetitive 5-day cycles of intramuscular methotrexate as primary therapy for metastatic trophoblastic disease between 1975 and 1990. The majority of patients were low-risk by both clinical and World Health Organization prognostic index score criteria. Sixty percent achieved primary remission with a median of 3 cycles of single-agent methotrexate. Therapy was changed because of toxicity and drug-resistance by hCG criteria in 11 (21%) and 10 (19%) patients, respectively. Pretherapy hCG > 10,000 mIU/ml was associated with the development of drug-resistance. Remission was achieved in all patients, with only 2 (4%) requiring multiagent therapy. The use of repetitive 5-day cycles of methotrexate is efficacious therapy of low-risk metastatic trophoblastic disease. Future studies are needed to define a cost-effective and minimally toxic therapy that retains a high primary remission rate in these patients.