title: A phase II study of conventional radiation therapy and thalidomide for supratentorial, newly-diagnosed glioblastoma (RTOG 9806).
abstract: The Radiation Therapy Oncology Group (RTOG) initiated the single-arm, phase II study 9806 to determine the safety and efficacy of daily thalidomide with radiation therapy in patients with newly diagnosed glioblastoma. Patients were treated with thalidomide (200 mg daily) from day one of radiation therapy, increasing by 100-200 to 1,200 mg every 1-2 weeks until tumor progression or unacceptable toxicity. The median survival time (MST) of all 89 evaluable patients was 10 months. When compared with the historical database stratified by recursive partitioning analysis (RPA) class, this end point was not different [hazard ratio (HR) = 1.18; 95 % CI: 0.95-1.46; P = 0.93]. The MST of RPA class III and IV patients was 13.9 versus 12.5 months in controls (HR = 0.99; 95 % CI: 0.73-1.36; P = 0.48), and 4.3 versus 8.6 months in RPA class V controls (HR = 1.63, 95 % CI: 1.17-2.27; P = 0.99). In all, 34 % of patients discontinued thalidomide because of adverse events or refusal. The most common grade 3-4 toxicities were venous thrombosis, fatigue, skin reactions, encephalopathy, and neuropathy. In conclusion, thalidomide given simultaneously with radiation therapy was safe, but did not improve survival in patients with newly diagnosed glioblastoma.
authors.affiliation: Dana-Farber/Brigham and Women's Cancer Center, 75 Francis Street, ASB1-L2, Boston, MA 02115, USA. bmalexander@lroc.harvard.edu
authors.forename: Brian M
authors.initials: BM
authors.lastname: Alexander
authors.forename: Meihua
authors.initials: M
authors.lastname: Wang
authors.forename: W K Alfred
authors.initials: WK
authors.lastname: Yung
authors.forename: Howard A
authors.initials: HA
authors.lastname: Fine
authors.forename: Bernadine A
authors.initials: BA
authors.lastname: Donahue
authors.forename: Ivo W
authors.initials: IW
authors.lastname: Tremont
authors.forename: Ray S
authors.initials: RS
authors.lastname: Richards
authors.forename: Kevin J
authors.initials: KJ
authors.lastname: Kerlin
authors.forename: Alan C
authors.initials: AC
authors.lastname: Hartford
authors.forename: Walter J
authors.initials: WJ
authors.lastname: Curran
authors.forename: Minesh P
authors.initials: MP
authors.lastname: Mehta
mesh_terms: D000293:Adolescent; D000328:Adult; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D059248:Chemoradiotherapy; D005260:Female; D005500:Follow-Up Studies; D005909:Glioblastoma / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D011379:Prognosis; D011879:Radiotherapy Dosage; D015996:Survival Rate; D013792:Thalidomide / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D020533:Angiogenesis Inhibitors; D013792:Thalidomide