Annals of Oncology 12:255-257, 2001
© 2001 European Society for Medical Oncology
research-article |
Temozolomide as a second-line systemic regimen in recurrent high-grade glioma: A phase II study
1Departments of Medical Oncology
2Departments of Neurological Sciences
3Departments of Neuroradiology
4Departments of Radiotherapy
5Departments of Neurosurgery
6Departments of Pathology Azienda Ospedaliera, Padova
7Departments of Neurosurgery Azienda Ospedaliera, Verona, Italy
Department of Medical Oncology-Direzione Azienda Ospedaliera Via Giustiniani 2 35100 Padova Italybrandes{at}uxl.unipd.it
BACKGROUND:: To investigate the efficacy of temozolomide in relation to response rate, toxicity, time to progression, and median survival time, a phase II study was conducted in patients with recurrent high-grade glioma following surgery plus radiotherapy and first-line chemotherapy based on nitro sourea, 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 multiforme, ten (24%) anaplastic astrocytoma, and nine (22%) anaplastic oligodendroglioma were administered temozolomide, 150 mg/m2/daily for five days every four weeks.
RESULTS:: Response was assessed in 40 patients. The overall response rate (complete + partial response) was 22.5% (95% confidence interval (CI): 9.5%–35%). The median time to progression for all 41 patients was 22.3 weeks; progression-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 significant (P = 0.03) for time to progression and Karnofsky performance score 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.
brain tumours, chemotherapy, recurrent, temozolomide
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