title: Treatment of low-risk gestational trophoblastic neoplasia comparing biweekly eight-day Methotrexate with folinic acid versus bolus-dose Actinomycin-D, among Brazilian women.
abstract: OBJECTIVE
  To compare two single-agent chemotherapy (ChT) regimens evaluating, in first-line treatment, response and side effects and, in final single-agent treatment, the outcomes, among Brazilian patients with low-risk gestational trophoblastic neoplasia (GTN), according to International Federation of Gynecology and Obstetrics (FIGO) 2002.
  
  
  METHODS
  Retrospective analysis of two concurrent cohorts with 194 low-risk GTN patients: from 1992 to 2012, as first-line treatment, 115 patients received 4 intramuscular doses of methotrexate alternated with 4 oral doses of folinic acid (MTX/FA) repetead every 14 days and, since 1996, 79 patients received an endovenous bolus-dose of actinomycin D (Act-D), biweekly. At GTN diagnosis, patient opinion was taken into consideration when defining the initial single-agent ChT regimen, and when there was resistance or toxicity to one regimen, the other drug was used preferentially. This study was approved by the Irmandade da Santa Casa de Misericórdia de Porto Alegre Ethical Committee.
  
  
  RESULTS
  Both groups were clinically similar (p>0.05). In first-line treatments, frequency of complete response was similar (75.7% with MTX/FA and 67.1% with bolus Act-D); the number of ChT courses -median 3 (range: 1-10) with MTX/FA and 2 (range: 1-6) with bolus Act-D - and the time to remission -median 9 weeks (range: 2-16) with MTX/FA and 10 weeks (range: 2-16) with bolus Act-D) - were not different between the groups. In both groups, first-line side effects frequency were high but intensity was low; stomatitis was higher with MTX/FA (p<0.01) and nausea and vomit with Act-D (p<0.01). Final single-agent ChT responses were high in both groups (94.8% with MTX/FA and 83.5% with bolus Act-D; p<0.01) and 13% higher in the group initially treated with MTX/FA. Rates of hysterectomy and of GTN recurrence were low and similar. No patient died due to GTN.
  
  
  CONCLUSIONS
  The two regimens had similar first-line ChT response. Final single-agent response rates were high and similar in both groups but the final single-agent remission rate was higher in the MTX/FA group.
authors.affiliation: Trophoblastic Disease Center, Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, RS, Brazil.
authors.forename: Elza Maria Hartmann
authors.initials: EM
authors.lastname: Uberti
authors.affiliation: Trophoblastic Disease Center, Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, RS, Brazil.
authors.forename: Maria do Carmo
authors.initials: Mdo C
authors.lastname: Fajardo
authors.affiliation: Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, RS, Brazil.
authors.forename: Adriana Gerhardt Vieira
authors.initials: AG
authors.lastname: da Cunha
authors.affiliation: Santa Rita Hospital, Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, RS, Brazil.
authors.forename: Sirlene Soares
authors.initials: SS
authors.lastname: Frota
authors.affiliation: School of Medicine, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brazil.
authors.forename: Antônio
authors.initials: A
authors.lastname: Braga
authors.affiliation: Irmandade da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, RS, Brazil.
authors.forename: Antonio Celso Koehler
authors.initials: AC
authors.lastname: Ayub
mesh_terms: D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001938:Brazil; D003609:Dactinomycin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D031901:Gestational Trophoblastic Disease / Q000188:drug therapy*; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage*; D008727:Methotrexate / Q000008:administration & dosage*; D008875:Middle Aged; D011247:Pregnancy; D012189:Retrospective Studies; D018570:Risk Assessment; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D003609:Dactinomycin; D002955:Leucovorin; D008727:Methotrexate