title: Phase II study of temozolomide and thalidomide with radiation therapy for newly diagnosed glioblastoma multiforme.
abstract: OBJECTIVE
  The chemotherapeutic agent temozolomide (TMZ) and the antiangiogenic agent thalidomide have both demonstrated antitumor activity in patients with recurrent malignant glioma. The objectives of this study were to determine if the combined strategy of these oral agents with radiation therapy (RT) is associated with an improved median survival of patients with newly diagnosed glioblastoma multiforme and to evaluate toxicity.
  
  
  METHODS
  Sixty-seven patients were enrolled in this trial. Radiotherapy parameters were a total dose of 60 Gy delivered in 2 Gy fractions over 6 weeks. Temozolomide was administered starting the first day of RT at 150 mg/m(2) daily for 5 days every 4 weeks for the first cycle and escalated to a maximum dose of 200 mg/m(2). Thalidomide was started on Day 7 of RT at 200 mg and escalated by 100-200 mg every 1-2 weeks depending on patient tolerance, to a maximum of 1,200 mg daily.
  
  
  RESULTS
  Sixty-one patients have progressed, with a median time to progression of 22 weeks. Fifty-six patients have died, and the median survival was 73 weeks.
  
  
  CONCLUSIONS
  This strategy of combination TMZ, thalid and RT was relatively well tolerated with favorable survival outcome for patients with GM when compared to patients not treated with adjuvant chemotherapy and similar to those who have received nitrosourea adjuvant chemotherapy. It is unclear the added advantage thalid has in combination with TMZ for this patient population.
authors.affiliation: Department of Neurological Surgery, University of California, San Francisco, San Francisco, CA, USA.
authors.forename: Susan M
authors.initials: SM
authors.lastname: Chang
authors.forename: Kathleen R
authors.initials: KR
authors.lastname: Lamborn
authors.forename: Mary
authors.initials: M
authors.lastname: Malec
authors.forename: David
authors.initials: D
authors.lastname: Larson
authors.forename: William
authors.initials: W
authors.lastname: Wara
authors.forename: Penny
authors.initials: P
authors.lastname: Sneed
authors.forename: Jane
authors.initials: J
authors.lastname: Rabbitt
authors.forename: Margaretta
authors.initials: M
authors.lastname: Page
authors.forename: M Kelly
authors.initials: MK
authors.lastname: Nicholas
authors.forename: Michael D
authors.initials: MD
authors.lastname: Prados
mesh_terms: D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001932:Brain Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005909:Glioblastoma / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077204:Temozolomide; D013792:Thalidomide / Q000008:administration & dosage
chemical_list: D020533:Angiogenesis Inhibitors; D018906:Antineoplastic Agents, Alkylating; D013792:Thalidomide; D003606:Dacarbazine; D000077204:Temozolomide