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Temozolomide in Children with progressive low-grade glioma¹

The Preston Robert Tisch Brain Tumor Center (S.G., J.A.Q., D.A.R., J.J.V., A.D., M.A.W., J.M.K., A.H.F., H.S.F.) and the Departments of Pediatrics (S.G., D.A.R., H.S.F.), Biostatistics and Bioinformatics (J.E.H.), Medicine (J.A.Q., J.J.V.), and Surgery (S.G., J.A.Q., D.A.R., J.J.V., A.H.F., H.S.F.), Duke University Medical Center, Durham, NC 27710; Division of Oncology, Children's Hospital of Philadelphia, Philadelphia, PA 19104 (M.J.F., P.C.P.); and the Departments of Pediatrics and Neurology, New York University Medical Center, New York, NY 10016 (J.C.A.); USA

² Please address correspondence to Sridharan Gururangan, Preston Robert Tisch Brain Tumor Center, Duke University Medical Center, Box 3624, Durham, NC 27710, USA (gurur002{at}mc.duke.edu).

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 significant proportion of the patients with OPG/PA, with manageable toxicity.

Key Words: low-grade glioma • phase II trial • responses • temozolomide

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