A phase II trial of temolozomide in patients with untreated high grade oligodengroglial brain tumours

Abstract

13005 Background: Whilst oligodendroglial tumours are chemosensitive, the data about Temozolomide in high grade oligodendrogliomas are almost exclusively in recurrent tumours. Methods: 40 untreated patients of a planned 50 with high grade oligodendrogliomas were enrolled in a Phase II trial of Temozolomide. Eligible patients had confirmed oligodendrogliomas/astrocytomas and adequate organ function. Patients were excluded for prior chemotherapy or radiotherapy. Once recovered from surgery, patients were treated with 6 monthly cycles of Temozolomide (200 mg/m2 for five days), with post-chemotherapy radiotherapy at investigator discretion. Patients were assessed for loss of heterozygosity (LOH) of 1p and 19q, which are markers of chemosensitivity. The primary endpoint was disease-free progression at six months. Results: Patients were accrued within 42 months with 17 women (42.5%) and 37 (92.5%) having a performance status (ECOG) 0–2. Eight patients did not complete the full 6 cycles (6 progressed during chem...