A Clinical Study Of Temozolomide Vs. Semustine In Patients With Malignant Gliomas

Purpose: A clinical study was performed to determine the safety and efficacy of temozolomide(TMZ) vs. semustine (CCNU) in patients with malignant gliomas.Methods: 55 eligible patients were randomized to divide into two groups during one year. TMZ and CCNU were administered respectively every 28 days according to body surface area. Meantime, clinical experience and blood examination should be performed every a month, and contrast-enhanced CT scan or GD-MRI was performed to evaluate the image-based progression comparing with the image before chemotherapy; which to evaluate disease progression and tolerability.Result: Image-based respond rates were 44.74% in TNZ group and 11. 77% in CCNU group, p=0. 017. 53% of patients experienced a clinical benefit with TMZ treatment, and 12% with CCNU, p=0. 017. The six month overall survival rate for TMZ patients was 60. 53% vs. 35. 29% for CCNU patients (p=0. 083). Non-hematologic toxicities were higher in rate in TMZ group than in CCNU group, but were easy to controlled and tolerated; and hematologic toxicities were lower in TMZ group than in CCNU group with none of grade III or IV severe adverse reaction and non-cumulatived myelotoxicity.Conclusion: TMZ expressed more efficient object respond rate compared with CCNU and better clinical experience improvement with little relative toxicities. Although the six-month survival rate doesnot be thought to have statistical significance, but TMZ could improve effectively quality of life. A further long time and comprehensive trail is warranted to prove and improve this study.