RTOG 0211: A Phase 1/2 Study of Radiation Therapy With Concurrent Gefitinib for Newly Diagnosed Glioblastoma Patients
- Department of Radiation Oncology, Arthur G. James Comprehensive Cancer Center and Richard L. Solove Research Institute, The Ohio State University, Columbus, Ohio (United States)
- Radiation Therapy Oncology Group (RTOG) Statistical Center, Philadelphia, Pennsylvania (United States)
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, Wisconsin (United States)
- Department of Neurosurgery, University of Toronto, Toronto, Ontario, Canada, and Department of Radiation Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia (United States)
- Department of Radiation Oncology, Arizona Oncology Services Foundation, Phoenix, Arizona (United States)
- Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin (United States)
- Neuroscience Institute, Norton Healthcare System, Louisville, Kentucky (United States)
- HistoRx, Branford, Connecticut (United States)
- Department of Neurological Surgery, University of California–San Francisco, San Francisco, California (United States)
- Ludwig Institute for Cancer Research, University of California–San Diego, La Jolla, California (United States)
- Radiation Oncology Department, Thomas Jefferson University, Philadelphia, Pennsylvania (United States)
Purpose: To determine the safety and efficacy of gefitinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in combination with radiation for newly diagnosed glioblastoma (GBM) patients. Methods and Materials: Between March 21, 2002, and May 3, 2004, Radiation Therapy Oncology Group (RTOG) 0211 enrolled 31 and 147 GBM patients in the phase 1 and 2 arms, respectively. Treatment consisted of daily oral gefinitnib started at the time of conventional cranial radiation therapy (RT) and continued post RT for 18 months or until progression. Tissue microarrays from 68 cases were analyzed for EGFR expression. Results: The maximum tolerated dose (MTD) of gefitinib was determined to be 500 mg in patients on non-enzyme-inducing anticonvulsant drugs (non-EIAEDs). All patients in the phase 2 component were treated at a gefitinib dose of 500 mg; patients receiving EIADSs could be escalated to 750 mg. The most common side effects of gefitinib in combination with radiation were dermatologic and gastrointestinal. Median survival was 11.5 months for patients treated per protocol. There was no overall survival benefit for patients treated with gefitinib + RT when compared with a historical cohort of patients treated with RT alone, matched by RTOG recursive partitioning analysis (RPA) class distribution. Younger age was significantly associated with better outcome. Per protocol stratification, EGFR expression was not found to be of prognostic value for gefitinib + RT-treated patients. Conclusions: The addition of gefitinib to RT is well tolerated. Median survival of RTOG 0211 patients treated with RT with concurrent and adjuvant gefitinib was similar to that in a historical control cohort treated with radiation alone.
- OSTI ID:
- 22224404
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 85, Issue 5; Other Information: Copyright (c) 2013 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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