Comparison of Methotrexate-Folinic Acid versus Pulsed Actinomycin-D in Treatment of Stage I, Low Risk Gestational Trophoblastic Neoplasia: A Randomized Clinical Trial

Jafari Shobeiri, Mehri and Vejdani, Razieh and Sayyah Melli, Manijeh and Oulad Saheb Madarek, Elaheh and Mostafa Garebaghi, Parvin and Atash khoei, Simin and Ghojazadeh, Morteza and Asgharzadeh, Ali (2014) Comparison of Methotrexate-Folinic Acid versus Pulsed Actinomycin-D in Treatment of Stage I, Low Risk Gestational Trophoblastic Neoplasia: A Randomized Clinical Trial. The Iranian Journal of Obstetrics, Gynecology and Infertility, 17 (91). pp. 1-11.

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Abstract

Introduction: Methotrexate and Actinomycin-D are still used for low risk gestational trophoblastic neoplasia (GTN). The aim of this study was to compare the efficacy and side effects of pulsed Actinomycin-D (ACT-D) and Methotrexate-Folinic Acid (MTX-FA) for Stage I, low-risk gestational trophoblastic neoplasia (GTN). Methods: This single-blind randomized clinical trial was conducted on 64 patients with stage I, low-risk GTN referred to gynecological oncology clinic of Tabriz University of Medical Sciences, Iran during 2011 and 2012. 32 patients were randomly assigned to receive a pulsed intravenous bolus of ACT-D 1.25 mg/m2 every 2 weeks and 32 patients received an intramuscular Methotrexate 1mg/kg per day on days 1,3,5,and 7 with intramuscular Folinic Acid 0.1 ml/kg per day on days 2,4,6, and 8. Data were analyzed using SPSS software (version 16) and Fisher exact test, Mann-Whitney U test, independent t-test and chi-square test. P value less than 0.05 was considered significant. Results: Response to treatment rate were 61.3 (19 patients) for MTX-FA group and 84.85 (28 patients) for ACT-D group (p=0.032). The risk of treatment failure with MTX-FA was 72 times more than ACT-D (p=0.032). The interval between drug administration and response was shorter with ACT-D in compare with MTX-FA (p<0.001). Drug toxicity necessitating changes in chemotherapy was reported in one out of 33 patients only in MTX-FA group. MTX-FA was more cost-effect regimen than ACT-D (p<0.001). Conclusion: Pulsed ACT-D may be an appropriate option as a first-line chemotherapy agent for patients with stage I, low-risk GTN

Item Type: Article
Subjects: WP Gynecology
WQ Obstetrics
Divisions: Journals > Iranian J Obstetrics, Gynecology and Infertility
Depositing User: ijogi ijogi
Date Deposited: 25 Sep 2017 17:12
Last Modified: 25 Sep 2017 17:12
URI: http://eprints.mums.ac.ir/id/eprint/4283

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