Abstract
Objectives: To compare the efficacy of weekly and eight-day methotrexate (MTX) regimens for the treatment of low-risk gestational trophoblastic neoplasia (GTN). Toxicity profiles, patient satisfaction, and treatment duration were also considered for future implications. Materials and Methods: This randomized controlled trial included all patients diagnosed with low-risk gestational trophoblastic neoplasia at King Abdulaziz University Hospital over a period of four years. The primary remission rate, duration of treatment, number of treatment cycles, as well as toxicity and the change of the chemotherapeutic agent were compared following either a weekly methotrexate regimen (IM, 50 mg/m(2)) or an eight-day regimen (1 mg/kg IM every other day for four doses) and leucovorin calcium (0.1 mg/kg, given once, 24 hours after each dose). Results: Sixty patients (34 in the weekly IM group) were included. The eight-day protocol was associated with lesser treatment cycles (p = 0.011) and higher total methotrexate dose (p < 0.001) when compared to the weekly regimen. The eight-day protocol showed a relatively higher primary success rate when compared to the weekly protocol (84.6% vs. 70.6%), although this difference failed to reach statistical significance (p = 0.235). Only two cases of hepatotoxicity were reported in the single weekly group and no toxicity was reported in the eight-day group. Conclusion: The eight-day regimen was superior to the weekly regimen in terms of the remission rate, treatment duration, and toxicity profiles. Future studies should be based on larger sample size, investigate methotrexate effects on fertility, and the risk factors that may lead to methotrexate resistance.