Temozolomide in children with progressive low-grade glioma

¹ The Preston Robert Tisch Brain Tumor Center and the Departments of Pediatrics and Surgery, Duke University Medical Center, Durham, NC 27710
² Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, PA 19104
³ Departments of Pediatrics and Neurology, New York University Medical Center, New York, NY 10016
⁴ Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC 27710
⁵ The Preston Robert Tisch Brain Tumor Center and the Departments of Medicine and Surgery, Duke University Medical Center, Durham, NC 27710
⁶ The Preston Robert Tisch Brain Tumor Center
⁷ The Preston Robert Tisch Brain Tumor Center and the Department of Surgery, Duke University Medical Center, Durham, NC 27710

^* To whom correspondence should be addressed. E-mail: gurur002{at}mc.duke.edu.

	Abstract

We conducted a phase II study to assess the efficacy of oral temozolomide (TMZ) in children with progressive low-grade glioma. Thirty eligible patients were enrolled on this study. Median age at enrollment was 10 years (range, 4-18 years). Eligible patients received TMZ (200 mg/m² per day) by mouth for five days every four weeks. Patients received a median of nine cycles (range, 2-12 cycles) of treatment. Best responses in the 26 patients (86%) with optic pathway glioma (OPG)/pilocytic astrocytoma (PA) included partial response in 3 patients (11%), minor response in 1 (4%), stable disease in 10 (38%), and progressive disease in 12 (46%). Only one of four patients with fibrillary astrocytoma had stable disease for 29 months after TMZ. The overall disease stabilization rate in patients with OPG/PA was 54%, and disease control was maintained for a median interval of 34 months. Seventeen of 26 patients had progressive disease either on or off therapy, and three have died of disease. The two-year progression-free and overall survivals in patients with OPG/PA were 49% (95% CI, 30%-67%) and 96% (95% CI, 89%-100%), respectively. Worst toxicity related to TMZ in all 30 patients included grade 2-4 thrombocytopenia in seven patients, grade 2-4 neutropenia in seven, grade 2 skin rash in one, and intratumor hemorrhage in one. TMZ given in this schedule was successful in stabilizing disease in a signficant proportion of the patients with OPG/PA, with manageable toxicity.

Key Words: Temozolomide, low-grade glioma, phase II trial, responses, 0

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