替膜唑胺联合放疗与单纯放疗治疗60例术后Ⅱ-Ⅳ级恶性胶质瘤的疗效比较  

Randomised Control Trial on Use of Adjuvant Temozolamide on Top of Radiotherapy in 60 Postoperative Patients with Grade Ⅱ-Ⅳ Glioma

作　　者：陆小军[1] 吴新光[1] 雷风[1] 刘玉猛[1] 叶亦菁[1] 郑斯明[1] 

机构地区：[1]中山市人民医院放疗科,广东中山市528403

出　　处：《中国神经肿瘤杂志》2005年第3期216-219,共4页Chinese Journal of Neuro-Oncology

基　　金：新疆生产建设兵团基金资助项目(NKB03SDXYY27SY)

摘　　要：背景与目的:采用替膜唑胺(Temozolomide,TMZ)联合放疗与单纯放疗治疗不全术后Ⅱ-Ⅳ级恶性胶质瘤,观察比较两组的局控率、生存率及不良反应。方法:对60例初治的不全术后Ⅱ-Ⅳ级恶性胶质瘤随机分为口服替膜唑胺加同期放疗组(TMZ-RT组)和单纯放疗组(RT组),两组各30例。替膜唑胺剂量为100- 200mg/m2.d,连续5天,每28天为一疗程,共3个疗程。两组放疗采用60C0 γ线照射,放疗开始时间均在术后 28天内。总量为55-60Gy。结果:TMZ-RT组与RT组总有效率(CR+PR)分别为80.0%和56.7%;1年累积局部复发率分别为7.14%(2/28)和28.0%(7/25);1年无复发生存率分别为92.9%(26/28)和72.0%(18/25)(P< 0.05)。TMZ-RT组常见不良反应是恶心,呕吐,白细胞和血小板下降,但仅限于Ⅰ-Ⅱ度。结论:TMZ-RT组与 RT组相比,在提高局控率、延缓肿瘤复发与提高患者无瘤生存期方面,TMZ-RT组要优于RT组。在不良反应方面,TMZ-RT组反应均较轻微,无治疗相关的死亡、终止或需降低放化疗剂量的病例。BACKGROUND ＆ OBJECTIVE：Gliomas are the most common primary intracerebral tumors and over 60% of these are malignant. Standard treatment for patients with gliomas consists of surgery and postoperative radiotherapy. Several phase II studies and one randomized trial suggest that temozolomide improves time to progression and quality of life but not overall survival. This paper is to compare and contrast the rate of local control, survival and safety between patients receiving temozolomide combined radiotherapy and radiotherapy alone in postoperative patients with grade Ⅱ -Ⅳ glioma. METHODS： 60 postoperative patients by initial treatment with grade Ⅱ -Ⅳ gliomas were randomly divided into two groups： oral temozolomide combined radiotherapy （TMZ-RT Group） and radiotherapy alone （RT-Group）. Temozolomide 100-200 mg/m^2 was administered once daily for 5 days and 28 days as a treatment course. Total 3 courses were performed. Radiotherapy was used by cobalt-60 in two groups. Radiotherapy was initially performed in 28 days after operation. The accumulated radiation dose was 55- 60Gy. RESULTS： The overall response rate （complete response and partial response） in the TMZ-RT Group and RT-Group were 80.0% and 56.7% respectively. The one-year cumulative local failure rate was 7.14% and 28% respectivdy.The one-year free from local failure survival rate（FLF）was 92.9% and 72.0%（P〈0.05）. The main toxicities including nausea, vomiting, leucopenia, and thrombocytopenia were not serious （grade Ⅰ-Ⅱ）. CONCLUSION： The TMZ-RT Group was well in local control rate, delaying relapse and increasing relapse free survival rate compared with RT-Group. The toxicities were little in both groups. There was no treatment-relative mortality. There was no need to terminate or decrease the dose of radiotherapy and chemotherapy.

关 键 词：胶质瘤 替膜唑胺 联合放疗 单纯放疗 

分 类 号：R739.41[医药卫生—肿瘤]