Randomized phase II study of temozolomide and radiotherapy compared with radiotherapy alone in newly diagnosed glioblastoma multiforme.

摘要: Purpose Surgery remains the standard treatment for glioma, followed by radiotherapy (RT) with or without chemotherapy. Despite multidisciplinary approaches, median survival time patients glioblastoma multiform (GBM) at less than 1 year from initial diagnosis. Temozolomide (TMZ), an oral alkylating agent, has shown promising activity in of malignant gliomas. We conducted a multicenter randomized phase II study comparing efficacy and safety TMZ administered concomitantly sequentially to RT versus alone newly diagnosed GBM. Patients Methods One hundred thirty pathologically confirmed, GBM were randomly assigned (110 assessable patients) receive either 75 mg/m2/d orally, (60 Gy 30 fractions; group A, n = 57), six cycles (150 mg/m2 on days through 5 15 19 every 28 days), B, 53). Results Median progre...