Methotrexate infusion and folinic acid as primary therapy for nonmetastatic and low-risk metastatic gestational trophoblastic tumors. 15 years of experience.

OBJECTIVE: To investigate the efficacy and toxicity of methotrexate (MTX) given intravenously (i.v.) at a dose of 100 mg/m2 i.v. bolus and 200 mg/m2 infusion over 12 hours followed by folinic acid in the primary treatment of gestational trophoblastic tumors (GTTs). STUDY
DESIGN: We reviewed the records of patients at the New England Trophoblastic Disease Center who had received MTX infusion at a dose of 100 mg/m2 i.v. bolus and 200 mg/m2 infusion over 12 hours followed by folinic acid as primary therapy for GTTs that did not resolve with uterine evacuation alone. Data on the patients' age, gravity and parity, disease stage (by FIGO and WHO criteria), antecedent pregnancy, presenting level of hCG, metastatic status, courses of chemotherapy required to achieve remission, toxicity related to chemotherapy treatments and time to normalization of hCG were recorded.
RESULTS: One hundred ninety-two patients with persistent GTTs were treated with the MTX infusion protocol between December 1985 and December 2000. One hundred twenty-four patients (64.6%) achieved complete remission with the MTX infusion protocol. Complete remission was induced in 108 (87.1%) with a single course of chemotherapy; 12 others achieved remission with a single additional course of MTX. All patients found to be resistant to MTX therapy later achieved remission with other chemotherapy. Minimal toxicity was experienced during MTX treatment.
CONCLUSION: MTX infusion with folinic acid is effective and well tolerated as primary single-agent therapy for nonmetastatic and low-risk metastatic GTT.