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Temozolomide as First-Line Agent in Treating High-Grade Gliomas: Phase II Study

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Abstract

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.

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Authors and Affiliations

  1. Department of Neurosurgery, Livorno Hospital, Italy

    S. Chibbaro, L. Benvenuti, A. Caprio, S. Carnesecchi, F. Pulerà, F. Faggionato, D. Serino & R. Gagliardi

  2. Department of Medical Oncology, Livorno Hospital, Italy

    C. Galli & M. Andreuccetti

  3. The Walton Centre for Neurology and Neurosurgery, Liverpool, UK

    N. Buxton

Authors
  1. S. Chibbaro
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  2. L. Benvenuti
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  3. A. Caprio
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  4. S. Carnesecchi
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  6. F. Faggionato
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  7. D. Serino
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  11. R. Gagliardi
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Chibbaro, S., Benvenuti, L., Caprio, A. et al. Temozolomide as First-Line Agent in Treating High-Grade Gliomas: Phase II Study. J Neurooncol 67, 77–81 (2004). https://doi.org/10.1023/B:NEON.0000021728.36747.93

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