Temozolomide as a second-line systemic regimen in recurrent high-grade glioma: A phase II study

Background: To investigate the efficacy of temozolomide in relation to resp onse rate, toxicity, time to progression, and median survival time, a phase II study was conducted in patients with recurrent high-grade glioma follow ing surgery plus radiotherapy and first-line chemotherapy based on nitrosou rea, procarbazine and vincristine. Patients and methods: Forty-one patients with high-grade glioma, at second recurrence or progression, of which twenty-two (54%) had glioblastoma multi forme, ten (24%) anaplastic astrocytoma, and nine (22%) anaplastic oligoden droglioma were administered temozolomide, 150 mg/m(2)/daily for five days e very four weeks. Results: Response was assessed in 40 patients. The overall response rate (c omplete + partial response) was 22.5% (95% confidence interval (CI): 9.5%-3 5%). The median time to progression for all 41 patients was 22.3 weeks; pro gression-free survival at 6 and 12 months was 48.5% and 34.7%, respectively . Median survival time was 37.1 weeks with 80.2% at 6 and 34.9% survival at 12 months. Conclusions: On multivariate analysis, response to previous treatment was s ignificant (P = 0.03) for time to progression and Karnofsky performance sco re for overall survivall (P = 0.002). Temozolomide gave a moderate response rate with acceptable toxicity as second-line chemotherapy in patients with recurrent high-grade glioma.