Retrospective analysis of safety and feasibility of a 3 days on/11 days off temozolomide dosing regimen in recurrent adult malignant gliomas.

Objective: We report the safety and feasibility of a 3 days on/11 days off temozolomide regimen for the treatment of recurrent malignant gliomas.

Methods: Fifteen adult patients were treated; 14 were treated with 300 mg/m(2) and one treated with 250 mg/m(2).

Results: We reviewed the toxicity, progression-free survival (PFS), overall survival and objective response rate. Two patients (13%) experienced grade 3 nausea/vomiting and six patients (40%) experienced grade 3 lymphopenia. Dose reduction and treatment delay occurred in eight (53%) cases. One patient discontinued treatment due to uncontrolled nausea/vomiting. Median PFS for glioblastoma patients was 4.1 months and 6-month PFS was 25%. Twelve patients exhibited stable disease (86%), one patient (7%) had progressive disease and one patient (7%) showed a partial response.

Conclusions: The '3 on/11 off' temozolomide regimen for recurrent high-grade gliomas was tolerable and warrants further study in a larger, prospective study.