Five-Day Intravascular Methotrexate Versus Biweekly Actinomycin-D in the Treatment of Low-Risk Gestational Trophoblastic Neoplasia: A Clinical Randomized Trial.
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.



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.



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.



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.
*Department of Gynecological Oncology, Moheb Yas Women General Hospital, Tehran University of Medical Sciences, †Department of Gynecological Oncology, Vali-e-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran; ‡Rosenfeld Cancer Center, Abington Memorial Hospital, Abington, Pennsylvania.
Fariba
F
Yarandi
Azamsadat
A
Mousavi
Fereshteh
F
Abbaslu
Soheila
S
Aminimoghaddam
Sepideh
S
Nekuie
Khadijeh
K
Adabi
Parviz
P
Hanjani
D000328:Adult; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D003609:Dactinomycin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D031901:Gestational Trophoblastic Disease / Q000188:drug therapy*; D006801:Humans; D007273:Injections, Intramuscular; D007275:Injections, Intravenous; D008727:Methotrexate / Q000008:administration & dosage*; D011247:Pregnancy; D011446:Prospective Studies
D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D003609:Dactinomycin; D008727:Methotrexate