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Efficacy and toxicity of two different schedules of methotrexate/folinic acid therapy in patients with low-risk postmolar gestational trophoblastic neoplasia

Grant number: 15/12530-0
Support type:Scholarships abroad - Research
Effective date (Start): September 22, 2015
Effective date (End): December 21, 2015
Field of knowledge:Health Sciences - Medicine - Maternal and Child Health
Principal researcher:Izildinha Maestá
Grantee:Izildinha Maestá
Host: Ross Stuart Berkowitz
Home Institution: Faculdade de Medicina (FMB). Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil
Research place: Harvard University, Boston, United States  


Introduction: Low-risk gestational trophoblastic neoplasia (GTN) can be successfully treated with single agent chemotherapy, usually methotrexate (MTX) or actinomycin-D (actD). MTX associated with folinic acid (FA) is the most used treatment, as it is less toxic than MTX alone or actD as a single agent. Objective: To assess the efficacy and toxicity of two different schedules of 8-day MTX/FA in patients with low-risk postmolar GTN. Methods: This retrospective cohort study will include patients with low-risk postmolar GTN treated with MTX/FA at the New England Trophoblastic Disease Center (NETDC), between 1974 and 2014. Study participants will be allocated into two groups, according to the 8-day MTX/FA schedule used: MTX/FA1- one single cycle followed by the monitoring of hCG regression curve; MTX/FA2 - continuing cycles at 2-week intervals until hCG normalization, followed by consolidation therapy. The efficacy of these two schedules will be evaluated through the occurrence of complete response, resistance and relapse. Toxicity will be assessed through the analysis of adverse events, which will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, National Cancer Institute. (AU)

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
MAESTA, IZILDINHA; NITECKI, RONI; HOROWITZ, NEIL S.; GOLDSTEIN, DONALD P.; SEGALLA MOREIRA, MARJORY DE FREITAS; ELIAS, KEVIN M.; BERKOWITZ, ROSS S.. Effectiveness and toxicity of first-line methotrexate chemotherapy in low-risk postmolar gestational trophoblastic neoplasia: The New England Trophoblastic Disease Center experience. GYNECOLOGIC ONCOLOGY, v. 148, n. 1, p. 161-167, . (15/12530-0)

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