title: Phase II trial of pulse dactinomycin as salvage therapy for failed low-risk gestational trophoblastic neoplasia: a Gynecologic Oncology Group study.
abstract: BACKGROUND
  The purpose of the study was to determine the activity and toxicity of pulse dactinomycin as salvage treatment of patients with low-risk gestational trophoblastic neoplasia (GTN) who failed methotrexate therapy.
  
  
  METHODS
  Eligible patients had persistent/recurrent low-risk GTN defined by changes in serum human chorionic gonadotropin (hCG) levels (<10% fall over 3 consecutive weekly titers, >20% rise over the previous value, or a rise after attaining institutional normal [>5 mu/mL]); World Health Organization (WHO) score 2-6; Gynecologic Oncology Group (GOG) performance status 0-1; and previous treatment restricted to methotrexate. Dactinomycin administration was 1.25 mg/m2 intravenous (i.v.) every 2 weeks until documented complete response (CR) or treatment failure. CR was defined as an institutional normal serum hCG level sustained for >or=4 consecutive weeks; treatment failure was a <10% fall (3 assays over 4 weeks) or >20% rise (over previous value) in hCG serum level. Levels were monitored biweekly x 8 weeks beyond the first normal value, then monthly x 10.
  
  
  RESULTS
  Five of 44 enrolled patients were ineligible due to choriocarcinoma and normal pretreatment serum hCG level (2 each), no history of methotrexate (1), and 1 patient with documented phantom hCG syndrome was unevaluable. In all, 28 of 38 (74%) evaluable patients attained CR. The median number of cycles was 4 (range, 2-10). Severe toxicity was minimal, causing no patient to discontinue therapy. All treatment failures achieved a CR after receiving subsequent chemotherapy; 3 patients also underwent hysterectomy.
  
  
  CONCLUSIONS
  Pulse dactinomycin is an active regimen for patients with low-risk GTN who fail previous methotrexate therapy.
authors.affiliation: Division of Gynecology/Oncology, University of Toronto, Toronto, Ontario, Canada. al.covens@sw.ca
authors.forename: Allan
authors.initials: A
authors.lastname: Covens
authors.forename: Virginia L
authors.initials: VL
authors.lastname: Filiaci
authors.forename: Robert A
authors.initials: RA
authors.lastname: Burger
authors.forename: Raymond
authors.initials: R
authors.lastname: Osborne
authors.forename: M Dwight
authors.initials: MD
authors.lastname: Chen
mesh_terms: D000328:Adult; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006063:Chorionic Gonadotropin / Q000097:blood; D003609:Dactinomycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D031901:Gestational Trophoblastic Disease / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007275:Injections, Intravenous; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D011247:Pregnancy; D020551:Pulse Therapy, Drug; D012307:Risk Factors; D016879:Salvage Therapy; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000903:Antibiotics, Antineoplastic; D006063:Chorionic Gonadotropin; D003609:Dactinomycin