title: Phase II study of Gleevec plus hydroxyurea in adults with progressive or recurrent low-grade glioma.
abstract: BACKGROUND
  We evaluated the efficacy of imatinib plus hydroxyurea in patients with progressive/recurrent low-grade glioma.
  
  
  METHODS
  A total of 64 patients with recurrent/progressive low-grade glioma were enrolled in this single-center study that stratified patients into astrocytoma and oligodendroglioma cohorts. All patients received 500 mg of hydroxyurea twice a day. Imatinib was administered at 400 mg per day for patients not on enzyme-inducing antiepileptic drugs (EIAEDs) and at 500 mg twice a day if on EIAEDs. The primary endpoint was progression-free survival at 12 months (PFS-12) and secondary endpoints were safety, median progression-free survival, and radiographic response rate.
  
  
  RESULTS
  Thirty-two patients were enrolled into each cohort. Eleven patients (17%) had before radiotherapy and 24 (38%) had received before chemotherapy. The median PFS and PFS-12 were 11 months and 39%, respectively. Outcome did not differ between the histologic cohorts. No patient achieved a radiographic response. The most common grade 3 or greater adverse events were neutropenia (11%), thrombocytopenia (3%), and diarrhea (3%).
  
  
  CONCLUSIONS
  Imatinib plus hydroxyurea was well tolerated among recurrent/progressive LGG patients but this regimen demonstrated negligible antitumor activity.
authors.affiliation: The Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Durham, North Carolina, USA. reard003@mc.duke.edu
authors.forename: David A
authors.initials: DA
authors.lastname: Reardon
authors.forename: Annick
authors.initials: A
authors.lastname: Desjardins
authors.forename: James J
authors.initials: JJ
authors.lastname: Vredenburgh
authors.forename: James E
authors.initials: JE
authors.lastname: Herndon
authors.forename: April
authors.initials: A
authors.lastname: Coan
authors.forename: Sridharan
authors.initials: S
authors.lastname: Gururangan
authors.forename: Katherine B
authors.initials: KB
authors.lastname: Peters
authors.forename: Roger
authors.initials: R
authors.lastname: McLendon
authors.forename: Sith
authors.initials: S
authors.lastname: Sathornsumetee
authors.forename: Jeremy N
authors.initials: JN
authors.lastname: Rich
authors.forename: Eric S
authors.initials: ES
authors.lastname: Lipp
authors.forename: Dorothea
authors.initials: D
authors.lastname: Janney
authors.forename: Henry S
authors.initials: HS
authors.lastname: Friedman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001254:Astrocytoma / Q000188:drug therapy* / Q000401:mortality; D001549:Benzamides; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015331:Cohort Studies; D003606:Dacarbazine / Q000031:analogs & derivatives / Q000627:therapeutic use; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage / Q000009:adverse effects; D000068877:Imatinib Mesylate; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D009503:Neutropenia / Q000139:chemically induced; D009837:Oligodendroglioma / Q000188:drug therapy* / Q000401:mortality; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects; D011743:Pyrimidines / Q000008:administration & dosage / Q000009:adverse effects; D000077204:Temozolomide; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D003606:Dacarbazine; D000068877:Imatinib Mesylate; D006918:Hydroxyurea; D000077204:Temozolomide