A phase II study of conventional radiation therapy and thalidomide for supratentorial, newly-diagnosed glioblastoma (RTOG 9806) |
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Authors: | Brian M Alexander Meihua Wang W K Alfred Yung Howard A Fine Bernadine A Donahue Ivo W Tremont Ray S Richards Kevin J Kerlin Alan C Hartford Walter J Curran Minesh P Mehta |
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Institution: | 1. Dana-Farber/Brigham and Women’s Cancer Center, 75 Francis Street, ASB1-L2, Boston, MA, 02115, USA 2. RTOG Statistical Center, Philadelphia, PA, USA 3. University of Texas-MD Anderson Cancer Center, Houston, TX, USA 4. Neuro-Oncology Branch, National Cancer Institute, Bethesda, MD, USA 5. Maimonides Medical Center, Brooklyn, NY, USA 6. Intermountain Medical Center, St. George, UT, USA 7. Southeast Cancer Control Consortium, Inc., CCOP, Winston-Salem, NC, USA 8. Dartmouth Hitchcock Medical Center, Lebanon, NH, USA 9. Winship Cancer Institute of Emory University, Atlanta, GA, USA 10. Northwestern Memorial Hospital, Chicago, IL, USA
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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. |
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