title: Phase II study of carboplatin in children with progressive low-grade gliomas.
abstract: OBJECTIVE
  To assess the rate of tumor response and activity of carboplatin in stabilizing the growth of progressive low-grade gliomas.
  
  
  METHODS
  Eligible patients received carboplatin 560 mg/m(2) intravenously every 4 weeks for 1 year after maximum tumor response or until disease progression or unacceptable toxicity.
  
  
  RESULTS
  Between October 1993 and October 2000, 81 children (median age, 79 months; range, 6 to 204) were enrolled onto this study. Patients received a median of 11 cycles of carboplatin (range, one to 29). Median follow-up from the time of enrollment was 55 months (range, 10 to 93). The overall objective response (complete response [CR] + partial response [PR] + minor response [MR]) and disease stabilization (CR + PR + stable disease + MR) rates to carboplatin treatment were 28% (95% confidence interval [CI], 18% to 38%) and 85% (95% CI, 74% to 93%), respectively. Eleven and 14 patients suffered progressive disease on study and after stopping therapy, respectively. Toxicity was predominantly myelosuppression and included grade 3/4 neutropenia in 56 patients and grade 3/4 thrombocytopenia in 40 patients. The 3-year failure-free survival (FFS) and overall survival (OS) for all patients were 64% (95% CI, 54% to 76%) and 84% (95% CI, 76% to 93%), respectively. Patients with diencephalic tumors had inferior FFS and OS compared with those with tumor at other sites (38% v 74% for FFS, P =.011; 54% v 91% for OS, P =.004). Neurofibromatosis type 1 patients with progressive low-grade glioma had a significantly better OS (95% v 80%; P =.052).
  
  
  CONCLUSIONS
  Carboplatin, in the schedule used in this study, produced disease stabilization or improvement in a majority of children with progressive low-grade glioma, with manageable toxicity. Improved treatment strategies are particularly required for patients with diencephalic tumors.
authors.affiliation: Duke University Medical Center, Durham, NC 27710, USA. gurur002@mc.duke.edu
authors.forename: Sridharan
authors.initials: S
authors.lastname: Gururangan
authors.forename: Christina M
authors.initials: CM
authors.lastname: Cavazos
authors.forename: David
authors.initials: D
authors.lastname: Ashley
authors.forename: James E
authors.initials: JE
authors.lastname: Herndon
authors.forename: Carol S
authors.initials: CS
authors.lastname: Bruggers
authors.forename: Albert
authors.initials: A
authors.lastname: Moghrabi
authors.forename: Deborah L
authors.initials: DL
authors.lastname: Scarcella
authors.forename: Melody
authors.initials: M
authors.lastname: Watral
authors.forename: Sandra
authors.initials: S
authors.lastname: Tourt-Uhlig
authors.forename: David
authors.initials: D
authors.lastname: Reardon
authors.forename: Henry S
authors.initials: HS
authors.lastname: Friedman
mesh_terms: D000293:Adolescent; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D005910:Glioma / Q000188:drug therapy*; D006801:Humans; D007223:Infant; D007262:Infusions, Intravenous; D008297:Male; D009367:Neoplasm Staging; D016879:Salvage Therapy; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D016190:Carboplatin