OBJECTIVE. To determine the anti-tumour efficacy and safety profile of temozolomide in local Chinese patients with recurrent malignant glioma.

DESIGN. Open-label trial.

SETTING. University teaching hospital, Hong Kong.

PATIENTS. Twenty-two patients had been enrolled in the study since 2001. Patients had to show unequivocal evidence of tumour recurrence or progression on gadolinium-enhanced magnetic resonance imaging after failing conventional radiotherapy and surgery for initial disease. Histology reviewed by a neuropathologist was required to show anaplastic glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, or mixed anaplastic oligoastrocytoma) or glioblastoma multiforme.

INTERVENTIONS. Patients were treated with temozolomide (200 mg/m2 per day for the first 5 days of a 28-day cycle for four cycles) and monitored clinically every month and radiologically (gadolinium magnetic resonance imaging) at 6 months.

MAIN OUTCOME MEASURES. Six-month progression-free survival and objective response rate.

RESULTS. Twenty-two patients with recurrent malignant glioma were recruited between January 2001 and July 2004. Progression-free survival at 6 months was 54.5%. The mean progression-free survival for all patients was 7.2 months. The objective response rate, determined by gadolinium magnetic resonance imaging, was 9% for patients demonstrating a complete or partial response and a further 45% for patients demonstrating stable disease. Temozolomide was well tolerated orally with minimal adverse events.

CONCLUSION. Preliminary results showed that temozolomide had an acceptable safety profile and anti-tumour activity in recurrent malignant glioma in local Chinese population. The results were comparable with those of western studies.

Key words: Astrocytoma; Brain neoplasms; Disease-free survival; Glioblastoma; Neoplasm recurrence

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