• Hong Kong Med J · Dec 2005

    Clinical Trial

    Temozolomide in the treatment of recurrent malignant glioma in Chinese patients.

    • D T M Chan, W S Poon, Y L Chan, and H K Ng.
    • Division of Neurosurgery, Department of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong.
    • Hong Kong Med J. 2005 Dec 1; 11 (6): 452-6.

    ObjectiveTo determine the anti-tumour efficacy and safety profile of temozolomide in local Chinese patients with recurrent malignant glioma. DESIGN. Open-label trial.SettingUniversity teaching hospital, Hong Kong.PatientsTwenty-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.InterventionsPatients were treated with temozolomide (200 mg/m(2) 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 MeasuresSix-month progression-free survival and objective response rate.ResultsTwenty-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.

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