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Five-Day Intravascular Methotrexate Versus Biweekly Actinomycin-D in the Treatment of Low-Risk Gestational Trophoblastic Neoplasia: A Clinical Randomized Trial
  1. Fariba Yarandi, MD,
  2. Azamsadat Mousavi, MD,
  3. Fereshteh Abbaslu, MD,
  4. Soheila Aminimoghaddam, MD,
  5. Sepideh Nekuie, MD,
  6. Khadijeh Adabi, MD and
  7. Parviz Hanjani, MD
  1. * Department of Gynecological Oncology, Moheb Yas Women General Hospital, Tehran University of Medical Sciences,
  2. Department of Gynecological Oncology, Vali-e-Asr Hospital, Tehran University of Medical Sciences, Tehran, Iran;
  3. Rosenfeld Cancer Center, Abington Memorial Hospital, Abington, Pennsylvania.
  1. Address correspondence and reprint requests to Khadijeh Adabi, Moheb Yas Women General Hospital, North Ostad Nejatolahi Avenue, Karim Khan Street, Tehran, Iran, Postcode 1598718311. E-mail: khadabi{at}


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/m2 (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.

  • Single-agent chemotherapy
  • Methotrexate
  • Actinomycin-D
  • Low-risk gestational trophoblastic neoplasia

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  • The authors received no funding for this work.

  • The authors declare no conflicts of interest.