ABSTRACT
This pilot study was conducted on 18 newly diagnosed patients with malignant glioma [11 patients with glioblastoma multiforme [GBM] and 7 patients with anaplastic astrocytoma [AA]] to assess the safety, tolerability and efficacy of concurrent administration of temozolomide [TMZ] and radiation. The eligible patients received 40 Gy [1.8 Gy/fraction, 1 fraction/day, 5 days/week] to the computed tomography [CT] or magnetic resonance imaging [MRI] enhancing lesion and surrounding edema with a 3 cm margin, then 20 Gy to a smaller volume including the contrast enhancing lesion plus 1-2 cm margin. Starting from the first day of radiation, the patients received oral TMZ [150 mg/m2] daily for 5 days and repeated every 28 days for two cycles. The study demonstrated the safety and efficacy of concurrent TMZ with radiation in newly diagnosed high grade gliomas and supported a further continued investigation of low daily dose TMZ with concurrent radiation, preferably with some cycles of TMZ as an adjuvant to radiation, in a multicenter phase III randomized trial containing a large number of patients and comparing this regimen with radiotherapy alone in newly diagnosed high-grade astrocytomas