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Treatment > Temozolomide Clinical Trials


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


Abstract

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

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

Department of Neurosurgery (S.C., L.B., A.C., S.C., F.P., F.F., D.S., R.G.), Department of Medical Oncology, Livorno Hospital, Italy (C.G., M.A.); The Walton Centre for Neurology and Neurosurgery, Liverpool, UK (N.B.)

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]

Source: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15072451


 

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