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Phase II study of neoadjuvant 1, 3‐bis (2‐chloroethyl)‐1‐nitrosourea and temozolomide for newly diagnosed anaplastic glioma: A North American Brain Tumor Consortium trial by Susan M. Chang; Michael D. Prados; W. K. Alfred Yung; Howard Fine; Larry Junck; Harry Greenberg; H. Ian Robins; Minesh Mehta; Karen L. Fink; Kurt A. Jaeckle; John Kuhn; Kenneth Hess; Clifford Schold is a Medicine article available to read on EtoBox.
What is Phase II study of neoadjuvant 1, 3‐bis (2‐chloroethyl)‐1‐nitrosourea and temozolomide for newly diagnosed anaplastic glioma: A North American Brain Tumor Consortium trial about?
## Abstract ## BACKGROUND Temozolomide (TMZ) and 1, 3‐bis (2‐chloroethyl)‐1‐nitrosourea (BCNU) are reported to be active agents in anaplastic glioma (AG). TMZ has also been shown to deplete alkyltransferase, a DNA repair enzyme that contributes to nitrosourea resistance. The objective of the current study was to determine the efficacy and toxicity profile of a combination of these agents before radiotherapy in newly diagnosed AG. ## METHODS Eligibility criteria included histologically confirmed newly diagnosed AG with measurable enhancing disease, a Karnofsky performance score (KPS) ≥ 60, normal pulmonary function, and normal laboratory parameters. In addition, informed consent was obtained from all patients. BCNU given at a dose of 150 mg/m^2^ intravenously was followed after 2 hours by TMZ given at a dose of 550 mg/m^2^ orally on Day 1 of a 42‐day cycle to a maximum of 4 cycles, unless there was tumor progression or unacceptable toxicity. ## RESULTS Forty‐one eligible patients were accrued. Their median age was 40 years. Seventy‐six percent of patients had a KPS of 90–100. The histology was 81% anaplastic astrocytoma, 12% anaplastic oligodendroglioma, and 7% mixed tumors. Twenty‐
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- Author
- Susan M. Chang; Michael D. Prados; W. K. Alfred Yung; Howard Fine; Larry Junck; Harry Greenberg; H. Ian Robins; Minesh Mehta; Karen L. Fink; Kurt A. Jaeckle; John Kuhn; Kenneth Hess; Clifford Schold
- Publisher
- John Wiley and Sons; Wiley (John Wiley & Sons); John Wiley & Sons Inc.; Wiley (ISSN 0008-543X)
- Published
- 2004
- Language
- EN
- Field
- Medicine (Health Sciences)