MULTICENTER CRC PHASE-II TRIAL OF TEMOZOLOMIDE IN RECURRENT OR PROGRESSIVE HIGH-GRADE GLIOMA

Purpose: Patients with progressive or recurrent supratentorial high-gr ade gliomas were entered into a multicentre phase II trial to evaluate the efficacy and toxicity of temozolomide. Methods: The treatment sch edule was 150-200 mg/m(2) per day orally for 5 days repeated every 28 days. Response evaluation was by a combination of neurological status evaluation (MRC scale) and imaging. Results: Of 103 eligible patients enrolled, Il (11%)achieved an objective response and a further 48 (47% ) had stable disease. The median response duration was 4.6 months. Res ponse rates were similar for anaplastic astrocytomas (grade III) and g lioblastoma multiforme (grade III) rumours. Predictable myelosuppressi on was the major toxicity. Conclusions: The observation of objective r esponses and tolerable side effects in this heterogeneous population o f patients supports the further investigation of this agent in high-gr ade gliomas.