放、化疗同步治疗高级别胶质瘤

目的比较单纯放疗与放疗加替莫唑胺（放疗同时和放疗后给药）治疗高级别胶质瘤的局控率、生存率及不良反应。方法对52例首次术后的问变性星形及胶质母细胞瘤随机分为接受单纯放疗（分次照射局部放疗，2Gy／d，5d／w，共持续6W，总剂量60Gy）、放疗加每天持续的替莫唑胺治疗（75mg／m^2／d），7d／w，从放疗开始到放疗结束）以及6个周期的替莫唑胺辅助治疗（150～200mg／m^2，治疗5d，每28d为一个疗程）。每组26例。主要研究目标为整体生存率。结果放疗加替莫唑胺（RT—TMZ）组与单纯放疗（RT）组总有效率（CR＋PR）分别为76．9％和50．0％；6个月无进展生存率分别为73．1％和46．2％；中位无进展生存期分别为8．8个月和6．2个月（P〈0．05）。1年累积局部复发率分别为42．3％和76．9％；1年无复发生存率分别为57．7％和23．1％，1年生存率分别为65．4％和30．8％（P〈0．05）。RT—TMZ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。结论两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RT—TMZ组要优于RT组，而不良反应方面两组反应均较轻微，所以放疗加替莫唑胺治疗新确诊的间变性星形及胶质母细胞瘤有效并能够明显提高生存率而毒副作用小。

Radiotherapy plus concomitant and adjuvant temozolomide for high grade glioma

Objective To compare the rate of local control, survival and safety in patients receiving radiotherapy alone and radiotherapy plus concomitant and adjuvant temozolomide （given concomitantly with and after radiotherapy） in postoperative patients with high grade gliomas. Method A total of 52 postoperative patients with anaplastic astrocytoma and glioblastoma were randomly divided into two goups： radiotherapy alone group （fractionated focal irradiation in daily fractious of 2 Gy given 5 days per weeks for 6 weeks, for a total of 60 Gy） and radiotherapy plus concomitant and adjuvant temozolomide group （75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy） followed by six cycles of adjuvant temozolomide （ 150 to 2130 mg per square meter for 5 days during each 28-day cycle）, each group with 26 patients. The primary end point was overall survival, Resuits The overall response rate （complete response and partial response） in the radiotherapy plus concomitant and adjuvant temozolomide （RT-TMZ） group and radiotherapy alone （RT） group were 76.9% and 50.0% respectively. The sixth-month cumulative local failure rates were 73.1% and 46.2% respectively. The onc-year currulative local failure rate was 42. 3% and 76. 9% respectively. The survival rate of onc-year free from ltwal failure （FLF） was 57.7% and 23. 1% respectively. The one-year survival rate was 65.4% and 30.8% respectively （P 〈0.05）. The main side effects including nausea, vomiting, leucopema, and thrombocytopenia were not serious （gradeI-ll）. Conclusion The RT-TMZ group is better in local control rate, delaying relapse and increasing relapse free survival rate compared with RT-group. The side effects are little in both groups. The treatment of radiotherapy plus concomitant temozolomide for newly diagnosed anaplastic astrocytoma and glioblastoma results in a chnically meaningful and statistically significant survival benefit with minimal additional toxicity.