Phase II trial of temozolomide and reirradiation using conformal 3D-radiotherapy in recurrent brain gliomas.

摘要: Purpose: This phase II trial was designed to assess the response rate, survival benefits and toxicity profile of temozolomide, brain reirradiation using conformal radiotherapy (RT) for treatment recurrent high grade glioma. Design: Open-label trial. Patients: Twenty-nine patients had been enrolled in study between February 2006 June 2009. Patients show unequivocal evidence tumour recurrence on gadolinium-enhanced magnetic resonance imaging (MRI) after failing conventional RT with or without temozolomide surgery initial disease. Histology included anaplastic astrocytoma, glioblastoma multiforme. Interventions: were treated by at a dose 200 mg/m 2 /day chemonaive patients, 150 previously 4-5 cycles. Then, underwent 30-40 Gy fractionation. Main outcome measures: The primary end point response. secondary points benefit. Results: All 29 reirradiation. Two achieved complete remission (CR), 4 partial (PR), an overall objective rate 20.6%, further 10 stable disease (SD), SD 34.4%. mean progression free (PFS) 10.1 months, (OS) 11.4 months. Additionally, significantly improved quality life (QOL). Treatment tolerated well mild 1, nausea/vomiting 40% cycles, haematological toxicities (neutropenia/thrombocytoprnia) 8.6% cycles. Conclusions: Temozolomide anti-tumor activity glioma, represented good hope glioma.