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Ann Oncol. 2001 Feb;12(2):255-7.

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

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1
Department of Medical Oncology, Azienda Ospedaliera, Padova, Italy. brandes@ux1.unipd.it

Abstract

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 nitrosourea, 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.

PMID:
11300334
DOI:
10.1023/a:1008336732273
[Indexed for MEDLINE]
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