Chemotherapy with Temozolomide in Patients with Malignant Glioma at First Relapse

Temozolomide is an alkylating agent that has demonstrated clinical antitumor activity and a relatively well-tolerated safety profile in patients with various advanced cancers, including malignant gliomas. We report the antitumor efficacy and safety profile of temozolomide in patients with malignant glioma at first relapse. Nineteen patients with astrocytic tumors (anaplastic oligoastrocytoma [AOA] : 2, anaplastic astrocytoma [AA] : 10, glioblastoma [GB] : 7) were treated. Median age was 50 years. Patients were treated with temozolomide 200 mg/m2/day. Patients previously treated with chemotherapy received temozolomide 150 mg/m2/day ; the dose could be increased to 200 mg/m2/day in the absence of grade 3/4 toxicity. Therapy was administered orally on the first 5 days of a 28-day cycle. Progression-free survival (PFS) at 6 months was 60%. The median PFS was 6.2 months. The median overall survival was 9 months. The objective response rate was 26% (5% complete response [CR], 21% partial response [P11]), with an additional 37% of patients with stable disease (SD). Adverse events were mild to moderate, with hematologic side effects occurring in 15% of patients. Temozolomide demonstrated good single-agent activity, an acceptable safety profile, and documented health-related quality of life benefits in patients with recurrent malignant glioma