OBJECTIVES:Methotrexate (MTX) and Actinomycin-D (Act-D) are effective drugs used in the treatment of low-risk gestational trophoblastic neoplasia (LRGTNs). The aim of the present study was to compare intravenous (IV) MTX and IV Act-D in the treatment of LRGTNs. MATERIALS AND METHODS:Sixty-two patients with LRGTN were enrolled in a prospective randomized clinical trial between 2010 and 2013 in Moheb e Yas Hospital, Tehran University of Medical Sciences. Primary treatment regimens were IV MTX, 0.4 mg/kg daily for 5 days every 14 days (25 mg maximum daily dose), and IV Act-D, 1.25 mg/m (2 mg maximum dose) every 14 days. RESULTS:Thirty-two and 30 patients were enrolled to MTX and Act-D groups, respectively. Complete remission after receiving first-line chemotherapy was achieved in 79% of all cases, 80% in the Act-D group and 78.1% in the MTX group.Twenty percent of the Act-D patients and 21.9% of the MTX patients showed resistance to the first-line chemotherapy, of which 16.7% and 15.6% responded completely to the second-line monotherapy, respectively. Multiple drug therapy was needed in 3.3% of the Act-D group and 6.3% of the MTX group.We did not find any correlation between treatment response and beta-human chorionic gonadotropin level, uterine mass size, lung metastasis, antecedent pregnancy, and duration from diagnosis to treatment. Adverse effects were not statistically different between the 2 groups. CONCLUSIONS: Single-agent chemotherapy in the treatment of LRGTNs resulted in an overall complete remission rate of 79%, 80% in the Act-D group and 78.1% in MTX group, with no statistically significant difference. Whereas this study represents an important step in comparing single-agent treatments, comparison of other regimens will be required to determine the optimal single-agent therapy.
RCT Entities:
OBJECTIVES:Methotrexate (MTX) and Actinomycin-D (Act-D) are effective drugs used in the treatment of low-risk gestational trophoblastic neoplasia (LRGTNs). The aim of the present study was to compare intravenous (IV) MTX and IV Act-D in the treatment of LRGTNs. MATERIALS AND METHODS: Sixty-two patients with LRGTN were enrolled in a prospective randomized clinical trial between 2010 and 2013 in Moheb e Yas Hospital, Tehran University of Medical Sciences. Primary treatment regimens were IV MTX, 0.4 mg/kg daily for 5 days every 14 days (25 mg maximum daily dose), and IV Act-D, 1.25 mg/m (2 mg maximum dose) every 14 days. RESULTS: Thirty-two and 30 patients were enrolled to MTX and Act-D groups, respectively. Complete remission after receiving first-line chemotherapy was achieved in 79% of all cases, 80% in the Act-D group and 78.1% in the MTX group.Twenty percent of the Act-D patients and 21.9% of the MTXpatients showed resistance to the first-line chemotherapy, of which 16.7% and 15.6% responded completely to the second-line monotherapy, respectively. Multiple drug therapy was needed in 3.3% of the Act-D group and 6.3% of the MTX group.We did not find any correlation between treatment response and beta-human chorionic gonadotropin level, uterine mass size, lung metastasis, antecedent pregnancy, and duration from diagnosis to treatment. Adverse effects were not statistically different between the 2 groups. CONCLUSIONS: Single-agent chemotherapy in the treatment of LRGTNs resulted in an overall complete remission rate of 79%, 80% in the Act-D group and 78.1% in MTX group, with no statistically significant difference. Whereas this study represents an important step in comparing single-agent treatments, comparison of other regimens will be required to determine the optimal single-agent therapy.