Purpose: The objective of the study was to evaluate the efficacy and toxicity of Temozolomide (TMZ) administered for 5 consecutive days in three daily dosing in children with recurrent or refractory high-grade glioma. Patients and methods: Twenty-four patients with a median age of 10.5 years were enrolled onto this open-label, multicenter. phase II study. The patients were previously treated with surgical resection (17 of 24), radiotherapy (19 of 24) and chemotherapy (18 of 24). Therapy was administered orally three times a day for 5 consecutive days at the dose of 200 mg/m(2) /dx5 for chemotherapy naive patients. In patients heavily pretreated with chemotherapy the starting dose was of 150 mg/m(2)/dx5. Results: A total of 95 cycles were administered. The median progression free-survival (PFS) was 3 months for the entire group while disease stabilization was obtained in 7 patients (29.1%). all with supratentorial tumors. No CR or PR was observed. TMZ treatment showed a limited toxicity. Thrombocytopenia was the most common hematological adverse effect. Our data suggest a marginal activity of TMZ in children with recurrent high-grade glioma.
Phase II trial of temozolomide in children with recurrent high-grade glioma / A., Ruggiero; G., Cefalo; M. L., Garre; M., Massimino; C., Colosimo; G., Attina; I., Lazzareschi; P., Maurizi; V., Ridola; G., Mazzarella; M., Caldarelli; C., Di Rocco; E., Madon; M. E., Abate; Clerico, Anna; A., Sandri; R., Riccardi. - In: JOURNAL OF NEURO-ONCOLOGY. - ISSN 0167-594X. - 77:1(2006), pp. 89-94. [10.1007/s11060-005-9011-2]
Phase II trial of temozolomide in children with recurrent high-grade glioma
CLERICO, Anna;
2006
Abstract
Purpose: The objective of the study was to evaluate the efficacy and toxicity of Temozolomide (TMZ) administered for 5 consecutive days in three daily dosing in children with recurrent or refractory high-grade glioma. Patients and methods: Twenty-four patients with a median age of 10.5 years were enrolled onto this open-label, multicenter. phase II study. The patients were previously treated with surgical resection (17 of 24), radiotherapy (19 of 24) and chemotherapy (18 of 24). Therapy was administered orally three times a day for 5 consecutive days at the dose of 200 mg/m(2) /dx5 for chemotherapy naive patients. In patients heavily pretreated with chemotherapy the starting dose was of 150 mg/m(2)/dx5. Results: A total of 95 cycles were administered. The median progression free-survival (PFS) was 3 months for the entire group while disease stabilization was obtained in 7 patients (29.1%). all with supratentorial tumors. No CR or PR was observed. TMZ treatment showed a limited toxicity. Thrombocytopenia was the most common hematological adverse effect. Our data suggest a marginal activity of TMZ in children with recurrent high-grade glioma.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
