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

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/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 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.