Phase II Trial of Temozolomide and Reirradiation Using Conformal Radiotherapy in Recurrent Brain Gliomas

Abstract

Purpose: This phase II trial was designed to assess the response rate, survival benefits and toxicity profile of temozolomide, and brain reirradiation using conformal radiotherapy for treatment of recurrent brain glioma. Design: Open-label phase II trial. Patients: Thirty patients had been enrolled in the study between February 2006 and June 2009. Patients had to show evidence of tumour recurrence on gadolinium-enhanced magnetic resonance imaging after failing conventional radiotherapy with or without temozolomide and surgery for initial disease. Histology included recurrent anaplastic astrocytoma, glioblastoma multiforme, low grade glioma, and ependymoma. Interventions: Patients were treated by temozolomide at a dose of 200 mg/m2/day for chemonaive patients,and at a dose of 150 mg/m2/day to previously treated patients, for 4-5 cycles. Then, patients underwent reirradiation by conformal radiotherapy at a dose of 30-40 Gy by conventional radiotherapy. Results: All the 30 patients were treated with temozolomide and reirradiation. Two patients achieved complete remission (CR), 5 achieved partial remission (PR), with an overall objective response rate of 23.3%, and further 10 patients had stable disease (SD), with a SD rate of 33.3%. The mean progression free survival (PFS) was 10.1 months, and the mean overall survival (OS) was 11.4 months. Additionally, treatment significantly improved quality of life (QOL). Treatment was tolerated well with mild grade 1, 2 nausea/vomiting in 40% of cycles, and mild grade 1, 2 hematological toxicities (neutropenia/thrombocytoprnia) in 9.6% of cycles. Conclusion: Temozolomide and conformal radiotherapy had an anti-tumor activity in recurrent malignant glioma, and represented a good treatment hope for patients with recurrent brain glioma.