Patients and methods Patients were stratified according to co-administration of enzyme-inducing anti-epileptic drugs (EIAEDs). There were 26 evaluable patients enrolled (16 on EIAEDs, 10 not on EIAEDs). All but seven patients had Glioblastoma Multiforme (GBM), and only six cases had a Karnosfsky Performance Status (KPS) of less than 80; median age was 51 years. All had received prior radiotherapy and 14 patients had no prior chemotherapy. The starting dose of temozolomide was 150 mg/m 2/day for 5 days every 28 days and could be escalated to a maximum dose of 200 mg/m 2/day in subsequent cycles. The starting dose of gefitinib was 500 mg/day given by mouth on a continuous basis. Dose-limiting toxicity was assessed in cycle one only.

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Results For patients on EIAEDs, the MTD of gefitinib was 1,000 mg/day in combination with temozolomide. Dose-limiting toxicity (DLT) was due to diarrhea, nausea and vomiting. For patients not on EIAEDs, the MTD was 250 mg/day in combination with temozolomide. The DLT was due to increases in liver transaminases. Rash was not a significant toxicity at these dose levels. The peak concentration and AUC 0-24hr at the 500 mg dose level was 1.8 and 2.5-fold lower, respectively, in the EIAED group compared to the non-EIAED group; trough levels of gefitinib increased in both groups consistent with the reported terminal half-life ranging from 27 to 51 h.

• Michael D. Prados • 1 • W. K. A. Yung • 2 • Patrick Y. Wen • 3 • Larry Junck • 4 • Timothy Cloughesy • 5 • Karen Fink • 6 • Susan Chang • 1 • H. Ian Robins • 7 • Janet Dancey • 8 • John Kuhn • 9 • 1. Department of Neurological Surgery University of California San Francisco San Francisco USA • 2. Department of Neuro-Oncology University of Texas MD Anderson Cancer Center Houston USA • 3. Dana-Farber Cancer Institute Boston USA • 4. Department of Neurology University of Michigan Hospital Ann Arbor USA • 5. Department of Neurosurgery University of California Los Angeles Los Angeles USA • 6. Department of Neurology University of Texas, Southwestern Medical Center Dallas USA • 7.

University of Wisconsin Hospital Madison USA • 8. National Cancer Institute, National Institutes of Health Bethesda USA • 9. Department of Neurology University of Texas, Southwestern Medical Center Dallas USA About this article.