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Temozolomide as first-line agent in treating high-grade gliomas: phase II study.

Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)


Posted on: 04/15/2004

Temozolomide as first-line agent in treating high-grade gliomas: phase II study.

J Neurooncol. 2004 Mar-Apr;67(1-2):77-81.

Chibbaro S, Benvenuti L, Caprio A, Carnesecchi S, Pulera F, Faggionato F, Serino D, Galli C, Andreuccetti M, Buxton N, Gagliardi R.

Department of Neurosurgery, Livorno Hospital, Italy.

Temozolomide a recent, oral, second generation alkylating agent is a chemotherapeutic with demonstrated efficacy for the treatment of high-grade gliomas; its efficacy has been demonstrated in both pre-clinical and phase I and II studies. The goal of this study is to determine the activity and safety of temozolomide in improving overall survival (OS), progression-free survival (PFS) and health-related quality of life (HQL) in patient with malignant gliomas. Forty-two patients with newly diagnosed glioblastoma, anaplastic astrocytoma and anaplastic oligodendroglioma were studied. The mean follow-up period was 12 months. The overall response rate (only responsive patient) for all histological groups was 40%, 10 patients (24%) showed a stabilization of disease. The median PFS and OS was respectively 8.35 and 14.1 months: time to progression was 34 week ranging from 21 to 47. In all patients, treatment with temozolomide was associated with improvement of performance status including the patient showing disease progression: Karnofski score improved in all patients by a minimum of 10, with a median of 20 at 6 months. No patient stopped the treatment due to side-effects, no major adverse events were recorded.

CONCLUSION: Temozolomide appears to be an ideal, first-line, single-agent, with a safe profile and demonstrated HQL benefits in patients with high-grade gliomas.

PMID: 15072451 [PubMed - in process]

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