Comparison of pulsed Actinomycin versus 5-day Methotrexate for the treatment of low-risk gestational trophoblastic disease in patients

The purposes of the study:Comparison of the recurrence and remission rate as well as the duration and complications of the treatment or patients with low risk gestational trophoblastic neoplasm by either pulse Actinomycine and Methotrexate.Study design:Among patients with gestational trophoblastic neoplasm who attended MirzaKuchekkhan and Imam Khomeini Hospital through years 2011 to 2014 a sample of 44 patients were selected (the volume of the sample calculated by convenience method)and filter through exclusion and inclusion criteria.Inclusion criteria: Postmolar Gestational trophoblastic neoplasm who meet FIGO stage 1,2,3criteria. Patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria : Less than 10% decrease in the βHCG level using as a reference the first value in the series of 4 values taken over a period of 3weeks ; More than 20% sustained rise in the βHCG taking as a reference the first value in The series of 3 values taken over a period of 2weeks (more than50 ); Persistently elevated βHCG level a period of 6 months (more than50 ); W.H.O. risk score 0-6; Patients must have normal hepatic, hematologic, and renal function Exclusion criteria: Patients who do not have GTN as defined Criteria; Patients who have previously been treated with cytotoxic chemotherapy. However, patients who received prior low-dose methotrexate for treatment of an ectopic pregnancy will be eligible for this study; Patients with placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT); Patients who wish to breast-feed during treatment; Patients with non-gestational choriocarcinoma; Disease progression; Pregnancy. Interventions: Group 1:Actinomycin pulse protocol(1.25 miligram per square meter)every 14 days intra vascular (maximum dose 2 miligram) ; Group2 :Methotrexate protocol (4 miligram perkilogram)every 14 days intravascular (maximum dose25 miligram) . Outcome measures: Each cycle of treatment is fourteen days with measuring the βHCG every two weeks.Once βHCG falls below5,another three cycles of chemothrapy is done unless there are signs of treatmentfailure or progression of the disease or unacceptable complications of the medication.Hence in such cases the patients get out the study.Patients are followed by βHCG every month for a year.If the βHCG levels remain high, the patients eventually go through 13 cycles of chemotherapy.

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