Comparison of Two Therapeutic Regimens: Methotrexate-Folinic Acid (8 days) and Weekly Methotrexate in Patients with Low risk Gestational Trophoblastic neoplasia

Abstract

<strong>Background:</strong> Methotrexate is used in the treatment of Low-risk Gestational Trophoblastic Neoplasia. The purpose of this study was to compare the therapeutic responses and side effects of two therapeutic methods which were prescribed for patients suffering from Low-risk Gestational Trophoblastic Neoplasia. One method was the <em>daily use of Methotrexate-Folic Acid</em> (for 8 days) and the other was the <em>weekly use of Methotrexate.</em> <strong>Methods:</strong>This study is a randomized double-blind clinical trial which was undertaken on 122 patients suffering from Low-risk Gestational Trophoblastic Neoplasia, who referred to AfzaliPoor Hospital in Kerman City, Iran. The patients were randomly divided into two groups: one group took Methotrexate-Folic Acid daily for a period of 8 days (muscular taking of one milligram/kilogram of Methotrexate in days 1,3,5 and 7; and 0.1 milligram/kilogram of Folic Acid in days 2,4,6 and 8); the other group took the same medication weekly (muscular taking of 30 to 50 milligrams per each square meter of body mass every week). <strong>Results:</strong> Findings showed that 95% of the patients effectively responded to the <em>8-day regimen</em> and 90% responded to <em>weekly regimen</em>. Five percent of the <em>8-day regimen</em> group and 10% of the <em>weekly regimen </em>group needed a second treatment. This difference was not significant. Concerning the related side effects, only one patient in the <em>weekly regimen</em> group experienced nausea and vomiting, and one patient experienced neutropenia; while 4 patients in the <em>8-day regimen</em> group experienced nausea and vomiting, one patient had mucositis, 2 patients had conjunctivitis, two patients experienced neutropenia, and one patient had thrombocytopenia. <strong>Conclusions:</strong> Considering the related costs, the <em>8-day regimen was </em>significantly more economical and affordable than the <em>weekly regimen.</em>