Methotrexate for 2000 FIGO Low-Risk Gestational Trophoblastic Neoplasia Patients: Efficacy and Toxicity

Abstract

Low-risk gestational trophoblastic neoplasia (GTN) responds well to chemotherapy and especially to a single agent, methotrexate (MTX), which is first-line therapy for low-risk (metastatic and nonmetastatic) disease. There are limited data on the results of treatment for patients with GTN with staging of disease classified according to the 2000 International Federation of Gynecology and Obstetrics (FIGO) classification and the FIGO scoring system. This retrospective study investigated the effectiveness and safety of an 8-day MTX regimen in the treatment of 142 patients with low-risk GTN who were diagnosed according to FIGO staging/scoring criteria. Data were obtained from review of medical records of all patients treated at the French Trophoblastic Disease Reference Center between 1999 and 2006. Patients with a FIGO risk score ≤6 were classified as having low-risk GTN, were treated with single-agent MTX and were followed by weekly measurements of serum human chorionic gonadotropin until the levels returned to normal. Patients were followed for a mean of 19.4 months ± 8.9 SD. The overall remission rate was 77.5% (110/142 patients) with the 8-day MTX protocol. Remission was achieved in 99.9% of patients with low-risk GTN who remained disease-free until the time of analysis. MTX was generally well-tolerated. Only 6 of the 142 patients (4.2%) had severe grade 3 or 4 toxicity. No major grade 4 side effects occurred other than 2 cases of bone/marrow toxicity that resolved without complications after appropriate therapy. The investigators conclude from these findings that use of the 8-day MTX regimen in patients with low-risk GTN provides both adequate treatment and low toxicity according to the 2000 FIGO scoring/staging system. The excellent global cure rate of 99.9% achieved with this regimen will allow patients to retain fertility. In addition, the data show that the required use of the FIGO criteria will allow comparison with future reports on MTX treatment for low-risk GTN.